fluticasone furoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4554	397864-44-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluticasone furoate avamys veramyst	Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti‑inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma. Molecular weight: 538.58 Formula: C27H29F3O6S CLOGP: 4.26 LIPINSKI: 1 HAC: 6 HDO: 1 TPSA: 93.81 ALOGS: -4.09 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fluticasone furoate
avamys
veramyst

Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti‑inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.

Molecular weight: 538.58
Formula: C27H29F3O6S
CLOGP: 4.26
LIPINSKI: 1
HAC: 6
HDO: 1
TPSA: 93.81
ALOGS: -4.09
ROTB: 6

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.20	mg	N
0.11	mg	N
0.60	mg	Inhal.aerosol
0.60	mg	Inhal.powder
1.50	mg	Inhal.solution

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	4.95 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	13.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	10.60 hours	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	0.01 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability)	0.14 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company
April 22, 2009	PMDA	GlaxoSmithKline K.K.
April 27, 2007	FDA	GLAXOSMITHKLINE
Jan. 11, 2008	EMA	GlaxoSmithKline (Ireland) Limited

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Macular degeneration	770.62	18.23	278	16913	24098	63447733
Asthma	528.59	18.23	363	16828	127198	63344633
Wheezing	421.70	18.23	283	16908	95312	63376519
Obstructive airways disorder	409.64	18.23	168	17023	20531	63451300
Full blood count abnormal	311.37	18.23	158	17033	31559	63440272
Nasal congestion	245.99	18.23	176	17015	65484	63406347
Therapeutic product effect incomplete	232.24	18.23	223	16968	124833	63346998
Blepharospasm	199.01	18.23	71	17120	5925	63465906
Gastrooesophageal reflux disease	195.58	18.23	180	17011	95459	63376372
Sleep disorder due to a general medical condition	169.00	18.23	77	17114	12111	63459720
Chronic sinusitis	168.25	18.23	78	17113	12765	63459066
Dyspnoea	160.23	18.23	465	16726	660848	62810983
Throat clearing	158.85	18.23	48	17143	2371	63469460
Taste disorder	154.55	18.23	75	17116	13587	63458244
Blood immunoglobulin E increased	133.12	18.23	47	17144	3802	63468029
Bronchial haemorrhage	127.14	18.23	30	17161	562	63471269
Bronchial neoplasm	126.80	18.23	29	17162	471	63471360
Malignant mediastinal neoplasm	118.20	18.23	34	17157	1412	63470419
Cough	116.13	18.23	249	16942	292494	63179337
Nasal turbinate hypertrophy	114.62	18.23	29	17162	734	63471097
Bronchiectasis	109.57	18.23	63	17128	16079	63455752
Bronchial disorder	108.44	18.23	31	17160	1259	63470572
Chest discomfort	108.40	18.23	141	17050	109828	63362003
Endometrial ablation	107.89	18.23	29	17162	935	63470896
Rhinorrhoea	106.79	18.23	109	17082	65468	63406363
Dyspnoea exertional	105.11	18.23	104	17087	60198	63411633
Nasal obstruction	103.65	18.23	32	17159	1699	63470132
Paraesthesia oral	101.80	18.23	64	17127	19192	63452639
Secretion discharge	100.13	18.23	54	17137	12177	63459654
Epilepsy	99.96	18.23	72	17119	26993	63444838
Productive cough	99.19	18.23	103	17088	63105	63408726
Procedural pain	95.16	18.23	64	17127	21505	63450326
Hyper IgE syndrome	94.81	18.23	23	17168	487	63471344
Eczema	90.78	18.23	73	17118	32218	63439613
Dust allergy	87.44	18.23	23	17168	681	63471150
Rhonchi	87.35	18.23	31	17160	2545	63469286
Nasal polyps	80.08	18.23	37	17154	6002	63465829
Sputum discoloured	78.15	18.23	51	17140	16296	63455535
Restrictive pulmonary disease	77.97	18.23	26	17165	1769	63470062
Respiratory tract inflammation	71.52	18.23	19	17172	585	63471246
Chronic obstructive pulmonary disease	69.04	18.23	85	17106	62601	63409230
Rhinitis	65.71	18.23	40	17151	11326	63460505
Sleep apnoea syndrome	65.68	18.23	58	17133	29075	63442756
Affective disorder	64.30	18.23	32	17159	6114	63465717
Migraine	62.00	18.23	105	17086	103241	63368590
Breath sounds abnormal	61.86	18.23	38	17153	10935	63460896
Weight decreased	61.14	18.23	189	17002	276609	63195222
Granuloma	60.28	18.23	30	17161	5731	63466100
Blood test abnormal	58.66	18.23	42	17149	15587	63456244
Total lung capacity increased	53.43	18.23	21	17170	2289	63469542
Polycystic ovaries	51.92	18.23	25	17166	4446	63467385
Toxicity to various agents	51.79	18.23	4	17187	247246	63224585
Haemoptysis	49.01	18.23	49	17142	28677	63443154
Asthma-chronic obstructive pulmonary disease overlap syndrome	48.60	18.23	19	17172	2042	63469789
Dyspepsia	47.53	18.23	93	17098	102103	63369728
Respiratory disorder	46.29	18.23	55	17136	39027	63432804
Alopecia	45.96	18.23	17	17174	337519	63134312
Lung hyperinflation	45.49	18.23	16	17175	1279	63470552
Paraesthesia	44.14	18.23	117	17074	156849	63314982
Arthropathy	43.51	18.23	6	17185	234786	63237045
Death	42.97	18.23	24	17167	374357	63097474
Dyslipidaemia	42.68	18.23	26	17165	7367	63464464
Drug ineffective	42.13	18.23	449	16742	1044316	62427515
Sinusitis	42.11	18.23	146	17045	226507	63245324
Memory impairment	41.53	18.23	89	17102	104169	63367662
Vaginal flatulence	40.02	18.23	19	17172	3274	63468557
Systemic lupus erythematosus	39.52	18.23	5	17186	208913	63262918
Lactose intolerance	38.72	18.23	18	17173	2960	63468871
Sarcoidosis	38.46	18.23	24	17167	7098	63464733
Forced expiratory volume decreased	38.06	18.23	21	17170	4947	63466884
Crystal arthropathy	37.09	18.23	10	17181	326	63471505
Synovitis	36.52	18.23	4	17187	186914	63284917
Eye pruritus	33.99	18.23	33	17158	18638	63453193
Rhinitis allergic	33.98	18.23	27	17164	11700	63460131
Ear pruritus	33.83	18.23	18	17173	3947	63467884
Respiratory tract infection	32.99	18.23	48	17143	41435	63430396
Female genital tract fistula	32.30	18.23	22	17169	7537	63464294
Ligament pain	31.30	18.23	8	17183	211	63471620
Proctitis	31.06	18.23	19	17172	5422	63466409
Loss of personal independence in daily activities	30.94	18.23	76	17115	97214	63374617
Wound	30.64	18.23	4	17187	163259	63308572
Glossodynia	29.96	18.23	6	17185	178870	63292961
Joint swelling	29.71	18.23	27	17164	327639	63144192
Herpes zoster	29.01	18.23	67	17124	82395	63389436
Ankle fracture	27.81	18.23	29	17162	17826	63454005
Seasonal allergy	27.34	18.23	31	17160	20919	63450912
Asthmatic crisis	26.85	18.23	12	17179	1801	63470030
Oral candidiasis	26.85	18.23	32	17159	22766	63449065
Contraindicated product administered	26.35	18.23	13	17178	217635	63254196
Hepatic enzyme increased	26.18	18.23	11	17180	202317	63269514
Rales	26.09	18.23	24	17167	12673	63459158
Abscess	25.83	18.23	27	17164	16641	63455190
Sneezing	25.56	18.23	28	17163	18190	63453641
Fall	25.38	18.23	42	17149	392292	63079539
Eosinophilia	25.26	18.23	31	17160	22725	63449106
Restless legs syndrome	25.17	18.23	28	17163	18503	63453328
Eosinophil count increased	25.11	18.23	22	17169	10906	63460925
Abdominal discomfort	25.08	18.23	30	17161	320855	63150976
Radioallergosorbent test positive	24.88	18.23	5	17186	42	63471789
Eosinophilic granulomatosis with polyangiitis	24.68	18.23	12	17179	2180	63469651
Stomatitis	24.64	18.23	4	17187	138721	63333110
Vaginal discharge	24.16	18.23	20	17171	9178	63462653
Bronchitis	23.62	18.23	81	17110	124854	63346977
Acute kidney injury	23.52	18.23	22	17169	263393	63208438
Discomfort	23.49	18.23	8	17183	167366	63304465
Thrombocytopenia	23.44	18.23	6	17185	151151	63320680
Radiculopathy	23.20	18.23	19	17172	8592	63463239
General physical health deterioration	22.94	18.23	13	17178	201389	63270442
Breast conserving surgery	22.39	18.23	9	17182	1040	63470791
Pertussis	22.23	18.23	8	17183	683	63471148
Sinus tachycardia	22.14	18.23	30	17161	24238	63447593
Sensitivity to weather change	21.69	18.23	17	17174	7220	63464611
Chondrocalcinosis pyrophosphate	21.23	18.23	9	17182	1189	63470642
Stent placement	21.15	18.23	13	17178	3742	63468089
Hypoaesthesia	21.15	18.23	96	17095	168297	63303534
Seizure	21.08	18.23	5	17186	132629	63339202
Rash	20.74	18.23	80	17111	560791	62911040
Blood pressure systolic increased	20.65	18.23	42	17149	47355	63424476
Pulmonary function test decreased	20.55	18.23	13	17178	3934	63467897
Diarrhoea	20.54	18.23	112	17079	715254	62756577
Neutropenia	20.36	18.23	11	17180	174994	63296837
Subclavian vein thrombosis	20.24	18.23	10	17181	1880	63469951
Frustration tolerance decreased	20.06	18.23	16	17175	6972	63464859
Fatigue	19.91	18.23	150	17041	887878	62583953
Blood pressure diastolic abnormal	19.80	18.23	22	17169	14520	63457311
Sinus pain	19.70	18.23	12	17179	3398	63468433
Malaise	19.59	18.23	185	17006	415769	63056062
Swelling face	19.55	18.23	49	17142	63426	63408405
Pulmonary mass	19.21	18.23	27	17164	22569	63449262
Lung neoplasm malignant	19.03	18.23	25	17166	19608	63452223
Middle insomnia	18.73	18.23	20	17171	12623	63459208

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	307.30	20.80	168	8570	42488	34905705
Wheezing	230.76	20.80	138	8600	41264	34906929
Appendicolith	176.23	20.80	70	8668	8531	34939662
Appendicitis	139.74	20.80	70	8668	14737	34933456
Nasal polyps	127.03	20.80	40	8698	2463	34945730
Stress	106.99	20.80	76	8662	30271	34917922
Nasal congestion	105.81	20.80	68	8670	22989	34925204
Cardiogenic shock	101.62	20.80	70	8668	26548	34921645
Ventricular fibrillation	93.88	20.80	63	8675	22891	34925302
Therapeutic product effect incomplete	89.97	20.80	85	8653	50456	34897737
Sleep disorder due to a general medical condition	88.13	20.80	37	8701	5184	34943009
Blood phosphorus increased	86.32	20.80	41	8697	7680	34940513
Obstructive airways disorder	71.81	20.80	46	8692	15448	34932745
Ascites	67.41	20.80	70	8668	46501	34901692
Rhinitis	65.82	20.80	32	8706	6306	34941887
Foetal malformation	64.16	20.80	13	8725	125	34948068
Abdominal distension	64.11	20.80	76	8662	58416	34889777
Dry mouth	61.96	20.80	55	8683	30110	34918083
Lung diffusion disorder	57.51	20.80	12	8726	135	34948058
Myasthenia gravis	57.29	20.80	30	8708	6910	34941283
Sputum discoloured	56.71	20.80	31	8707	7781	34940412
Full blood count abnormal	55.03	20.80	42	8696	18626	34929567
Ocular discomfort	53.04	20.80	20	8718	2114	34946079
Seasonal allergy	52.68	20.80	28	8710	6647	34941546
Hyponatraemia	51.89	20.80	82	8656	82609	34865584
Blood uric acid increased	50.69	20.80	31	8707	9593	34938600
Cough	50.53	20.80	114	8624	150026	34798167
Fungal disease carrier	49.11	20.80	12	8726	285	34947908
Inguinal hernia repair	48.26	20.80	12	8726	307	34947886
Dyspnoea	44.69	20.80	199	8539	376583	34571610
Trisomy 18	41.95	20.80	13	8725	758	34947435
Nasal oedema	41.66	20.80	11	8727	359	34947834
Multiple organ dysfunction syndrome	41.37	20.80	71	8667	76495	34871698
Chronic sinusitis	41.32	20.80	17	8721	2262	34945931
Middle insomnia	41.26	20.80	24	8714	6778	34941415
Chest discomfort	39.74	20.80	58	8680	54472	34893721
Loss of personal independence in daily activities	39.47	20.80	45	8693	33134	34915059
Glaucoma	38.29	20.80	23	8715	6889	34941304
Rhinorrhoea	37.86	20.80	39	8699	25629	34922564
Oropharyngeal candidiasis	36.95	20.80	12	8726	815	34947378
Eye pruritus	36.59	20.80	23	8715	7466	34940727
Forced expiratory volume decreased	35.76	20.80	17	8721	3186	34945007
Chronic obstructive pulmonary disease	34.15	20.80	51	8687	48867	34899326
Dermatitis allergic	33.43	20.80	21	8717	6809	34941384
Constipation	32.37	20.80	91	8647	136891	34811302
Anosmia	32.09	20.80	17	8721	4007	34944186
Central obesity	31.91	20.80	10	8728	605	34947588
Victim of child abuse	31.70	20.80	11	8727	916	34947277
Toxicity to various agents	31.46	20.80	6	8732	200356	34747837
Eczema	30.85	20.80	30	8708	18406	34929787
SARS-CoV-2 sepsis	30.54	20.80	7	8731	125	34948068
Productive cough	30.15	20.80	42	8696	37771	34910422
Abdominal pain	29.61	20.80	99	8639	163519	34784674
Drug therapy	29.47	20.80	11	8727	1130	34947063
General physical health deterioration	29.12	20.80	84	8654	128185	34820008
Conjunctivitis	28.95	20.80	22	8716	9683	34938510
Blood cholesterol increased	28.12	20.80	30	8708	20513	34927680
Ocular hyperaemia	27.81	20.80	23	8715	11429	34936764
Analgesic therapy	27.17	20.80	10	8728	988	34947205
Nasal disorder	27.07	20.80	12	8726	1916	34946277
Sleep disorder therapy	26.92	20.80	10	8728	1013	34947180
Pharyngeal paraesthesia	26.83	20.80	9	8729	676	34947517
Nasal septum deviation	26.23	20.80	10	8728	1089	34947104
Stenotrophomonas infection	26.03	20.80	12	8726	2098	34946095
Cortisol decreased	25.98	20.80	10	8728	1117	34947076
Bronchial obstruction	25.76	20.80	11	8727	1605	34946588
Somnolence	25.43	20.80	73	8665	111043	34837150
Hyperphosphataemia	25.19	20.80	15	8723	4422	34943771
Iron deficiency	24.98	20.80	16	8722	5365	34942828
Eosinophilic pneumonia chronic	24.95	20.80	7	8731	288	34947905
Rhinitis allergic	24.64	20.80	13	8725	3037	34945156
Incorrect route of product administration	24.54	20.80	24	8714	14821	34933372
Polyp	24.32	20.80	14	8724	3878	34944315
Blood immunoglobulin E increased	23.89	20.80	12	8726	2534	34945659
Acute kidney injury	23.51	20.80	25	8713	304963	34643230
Blood test abnormal	23.48	20.80	17	8721	6954	34941239
Gastroenteritis eosinophilic	22.69	20.80	6	8732	197	34947996
Laryngeal discomfort	22.46	20.80	6	8732	205	34947988
Eosinophilic bronchitis	22.10	20.80	6	8732	218	34947975
Alpha 2 globulin decreased	22.02	20.80	4	8734	20	34948173
Otosalpingitis	22.02	20.80	4	8734	20	34948173
Free androgen index decreased	21.85	20.80	4	8734	21	34948172
Sex hormone binding globulin decreased	21.85	20.80	4	8734	21	34948172
Androgen insensitivity syndrome	21.70	20.80	4	8734	22	34948171
Viral acanthoma	21.70	20.80	4	8734	22	34948171
Testicular microlithiasis	21.40	20.80	4	8734	24	34948169
Dehydroepiandrosterone decreased	21.26	20.80	4	8734	25	34948168
Urine calcium/creatinine ratio increased	21.26	20.80	4	8734	25	34948168

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	698.69	16.54	454	22812	134641	79586481
Wheezing	585.63	16.54	385	22881	116279	79604843
Obstructive airways disorder	426.26	16.54	200	23066	31259	79689863
Full blood count abnormal	358.73	16.54	193	23073	40281	79680841
Nasal congestion	339.01	16.54	234	23032	76318	79644804
Therapeutic product effect incomplete	294.44	16.54	278	22988	141367	79579755
Sleep disorder due to a general medical condition	222.20	16.54	100	23166	14177	79706945
Chronic sinusitis	195.62	16.54	89	23177	12937	79708185
Nasal polyps	183.46	16.54	72	23194	7255	79713867
Dyspnoea	174.35	16.54	596	22670	856429	78864693
Appendicolith	162.66	16.54	69	23197	8482	79712640
Gastrooesophageal reflux disease	162.09	16.54	175	23091	104071	79617051
Cough	155.43	16.54	335	22931	366454	79354668
Throat clearing	155.06	16.54	49	23217	2605	79718517
Rhinorrhoea	142.19	16.54	141	23125	75933	79645189
Blood immunoglobulin E increased	137.48	16.54	55	23211	5827	79715295
Chest discomfort	127.20	16.54	178	23088	137866	79583256
Rhinitis	126.60	16.54	69	23197	14738	79706384
Bronchial neoplasm	124.18	16.54	29	23237	479	79720643
Blepharospasm	124.01	16.54	51	23215	5800	79715322
Sputum discoloured	121.67	16.54	77	23189	21666	79699456
Nasal turbinate hypertrophy	119.28	16.54	30	23236	685	79720437
Productive cough	117.93	16.54	137	23129	88194	79632928
Macular degeneration	117.47	16.54	60	23206	11236	79709886
Bronchiectasis	114.70	16.54	75	23191	22311	79698811
Eczema	114.33	16.54	95	23171	40723	79680399
Malignant mediastinal neoplasm	112.02	16.54	33	23233	1382	79719740
Endometrial ablation	107.94	16.54	29	23237	864	79720258
Appendicitis	104.91	16.54	69	23197	20725	79700397
Paraesthesia oral	103.45	16.54	68	23198	20403	79700719
Stress	102.14	16.54	121	23145	79491	79641631
Bronchial haemorrhage	101.07	16.54	30	23236	1290	79719832
Rhonchi	98.71	16.54	39	23227	3997	79717125
Nasal obstruction	94.27	16.54	32	23234	2132	79718990
Chronic obstructive pulmonary disease	93.73	16.54	120	23146	85299	79635823
Secretion discharge	93.67	16.54	57	23209	14965	79706157
Taste disorder	90.94	16.54	57	23209	15766	79705356
Toxicity to various agents	90.73	16.54	9	23257	421531	79299591
Hyper IgE syndrome	90.52	16.54	23	23243	548	79720574
Bronchial disorder	86.12	16.54	31	23235	2458	79718664
Restrictive pulmonary disease	84.86	16.54	31	23235	2564	79718558
Blood test abnormal	82.67	16.54	56	23210	17654	79703468
Procedural pain	82.43	16.54	62	23204	23022	79698100
Dyspnoea exertional	73.85	16.54	108	23158	86965	79634157
Blood phosphorus increased	69.01	16.54	41	23225	10306	79710816
Dust allergy	68.04	16.54	23	23243	1513	79719609
Sleep apnoea syndrome	66.98	16.54	67	23199	36411	79684711
Forced expiratory volume decreased	65.64	16.54	36	23230	7778	79713344
Ventricular fibrillation	64.90	16.54	62	23204	31864	79689258
Cardiogenic shock	64.43	16.54	70	23196	41844	79679278
Affective disorder	63.54	16.54	36	23230	8283	79712839
Respiratory tract inflammation	63.30	16.54	19	23247	849	79720273
Loss of personal independence in daily activities	59.38	16.54	107	23159	102473	79618649
Respiratory disorder	58.87	16.54	69	23197	44787	79676335
Seasonal allergy	58.43	16.54	44	23222	16362	79704760
Eye pruritus	57.84	16.54	48	23218	20522	79700600
Breath sounds abnormal	57.22	16.54	43	23223	15941	79705181
Sinusitis	57.20	16.54	155	23111	195346	79525776
Polycystic ovaries	54.15	16.54	25	23241	3754	79717368
Lung diffusion disorder	52.22	16.54	12	23254	184	79720938
Acute kidney injury	50.94	16.54	46	23220	519358	79201764
Granuloma	50.49	16.54	31	23235	8266	79712856
Migraine	49.02	16.54	90	23176	87403	79633719
Weight decreased	48.78	16.54	219	23047	354979	79366143
Total lung capacity increased	48.59	16.54	20	23246	2278	79718844
Middle insomnia	48.34	16.54	39	23227	16030	79705092
Epilepsy	47.32	16.54	59	23207	40801	79680321
Rhinitis allergic	46.14	16.54	34	23232	12235	79708887
Inguinal hernia repair	46.00	16.54	12	23254	318	79720804
Fungal disease carrier	45.10	16.54	12	23254	344	79720778
Myasthenia gravis	44.10	16.54	31	23235	10368	79710754
Vaginal flatulence	43.14	16.54	19	23247	2556	79718566
Dyspepsia	42.14	16.54	96	23170	108591	79612531
Lung hyperinflation	42.11	16.54	17	23249	1842	79719280
Lactose intolerance	41.66	16.54	18	23248	2312	79718810
Thrombocytopenia	41.29	16.54	13	23253	265246	79455876
Blood uric acid increased	39.29	16.54	32	23234	13328	79707794
Asthma-chronic obstructive pulmonary disease overlap syndrome	39.07	16.54	19	23247	3202	79717920
Anosmia	36.66	16.54	26	23240	8818	79712304
Proctitis	36.53	16.54	23	23243	6409	79714713
Treatment failure	35.70	16.54	4	23262	170482	79550640
Female genital tract fistula	35.53	16.54	22	23244	5953	79715169
Neutropenia	35.34	16.54	20	23246	287690	79433432
Polyp	33.99	16.54	24	23242	8083	79713039
Death	33.64	16.54	72	23194	566442	79154680
Synovitis	32.96	16.54	3	23263	150731	79570391
Dyslipidaemia	32.40	16.54	27	23239	11606	79709516
Eosinophilic pneumonia chronic	32.08	16.54	10	23256	508	79720614
Ear pruritus	31.94	16.54	18	23248	4097	79717025
Haemoptysis	31.86	16.54	58	23208	55941	79665181
Ascites	31.82	16.54	69	23197	75493	79645629
Bronchitis	31.80	16.54	97	23169	130547	79590575
Cardiac arrest	31.51	16.54	6	23260	172090	79549032
Haemoglobin decreased	30.98	16.54	13	23253	222106	79499016
Nasal oedema	29.78	16.54	13	23253	1711	79719411
Drug interaction	29.76	16.54	47	23219	415136	79305986
Victim of child abuse	29.74	16.54	11	23255	942	79720180
Respiratory tract infection	29.71	16.54	52	23214	48637	79672485
Dehydration	29.42	16.54	18	23248	248169	79472953
Ligament pain	29.41	16.54	8	23258	250	79720872
SARS-CoV-2 sepsis	29.25	16.54	7	23259	129	79720993
Blood pressure diastolic increased	29.09	16.54	28	23238	14514	79706608
Ankle fracture	29.01	16.54	30	23236	16939	79704183
Diarrhoea	28.66	16.54	146	23120	880343	78840779
Eosinophilic granulomatosis with polyangiitis	28.38	16.54	16	23250	3644	79717478
Abdominal distension	28.33	16.54	88	23178	119562	79601560
Respiratory failure	27.90	16.54	9	23257	180902	79540220
Swelling face	27.70	16.54	63	23203	71149	79649973
Herpes zoster	27.38	16.54	74	23192	93009	79628113
Drug therapy	27.27	16.54	11	23255	1190	79719932
Asthenia	27.18	16.54	69	23197	511620	79209502
Eosinophilia	27.12	16.54	48	23218	45297	79675825
Alopecia	27.11	16.54	17	23249	231338	79489784
Overdose	26.97	16.54	10	23256	184196	79536926
Hypotension	26.92	16.54	55	23211	440262	79280860
Sarcoidosis	26.71	16.54	21	23245	8314	79712808
Vaginal discharge	26.54	16.54	20	23246	7443	79713679
Oropharyngeal candidiasis	26.35	16.54	12	23254	1745	79719377
Ocular discomfort	26.26	16.54	17	23249	4966	79716156
Platelet count decreased	26.18	16.54	12	23254	194652	79526470
Cardiac failure congestive	25.99	16.54	5	23261	142397	79578725
Analgesic therapy	25.55	16.54	10	23256	999	79720123
Joint swelling	25.45	16.54	28	23238	288618	79432504
Sleep disorder therapy	25.41	16.54	10	23256	1014	79720108
Cardiac murmur	25.31	16.54	27	23239	15797	79705325
Gastrointestinal haemorrhage	25.30	16.54	6	23260	147713	79573409
Eosinophil count increased	25.29	16.54	28	23238	17077	79704045
Lower respiratory tract infection	25.20	16.54	89	23177	129131	79591991
Asthmatic crisis	24.84	16.54	12	23254	1994	79719128
Radioallergosorbent test positive	24.62	16.54	5	23261	41	79721081
Pancytopenia	24.26	16.54	9	23257	165736	79555386
Constipation	24.04	16.54	153	23113	282897	79438225
Oral candidiasis	24.02	16.54	36	23230	29592	79691530
Cortisol decreased	23.93	16.54	12	23254	2160	79718962
Sneezing	23.72	16.54	29	23237	19654	79701468
Sensitivity to weather change	23.08	16.54	19	23247	8028	79713094
Septic shock	23.08	16.54	4	23262	122797	79598325
Nasal disorder	22.72	16.54	14	23252	3755	79717367
Hyperphosphataemia	22.48	16.54	17	23249	6359	79714763
Malignant neoplasm progression	22.37	16.54	6	23260	135984	79585138
Paraesthesia	22.14	16.54	106	23160	176217	79544905
White blood cell count decreased	21.83	16.54	14	23252	188274	79532848
Radiculopathy	21.56	16.54	19	23247	8805	79712317
Stomatitis	21.42	16.54	8	23258	146749	79574373
Atopy	21.12	16.54	7	23259	433	79720689
Disease progression	20.98	16.54	14	23252	184348	79536774
Ovarian cyst	20.97	16.54	22	23244	12633	79708489
Febrile neutropenia	20.81	16.54	22	23244	230977	79490145
Contraindicated product administered	20.74	16.54	10	23256	157528	79563594
Sinus disorder	20.69	16.54	29	23237	22435	79698687
Renal failure	20.62	16.54	17	23249	200951	79520171
Breast conserving surgery	20.61	16.54	8	23258	782	79720340
Eosinophilic bronchitis	20.35	16.54	7	23259	485	79720637
Throat irritation	20.30	16.54	40	23226	40906	79680216
Rales	20.21	16.54	27	23239	19974	79701148
Central obesity	20.20	16.54	10	23256	1751	79719371
Oropharyngeal pain	20.20	16.54	74	23192	109279	79611843
Dry mouth	20.15	16.54	64	23202	87955	79633167
Memory impairment	20.13	16.54	75	23191	111659	79609463
Restless legs syndrome	20.11	16.54	27	23239	20065	79701057
Pertussis	19.82	16.54	8	23258	867	79720255
Crepitations	19.50	16.54	19	23247	9998	79711124
Cardio-respiratory arrest	19.40	16.54	4	23262	108506	79612616
Gastroenteritis eosinophilic	19.36	16.54	6	23260	299	79720823
Sleep disorder	19.35	16.54	62	23204	85615	79635507
Wound	19.35	16.54	5	23261	116174	79604948
Abscess	18.77	16.54	28	23238	22923	79698199
Lung neoplasm malignant	18.69	16.54	31	23235	27761	79693361
Bronchial obstruction	18.54	16.54	11	23255	2757	79718365
Neck injury	18.49	16.54	11	23255	2770	79718352
Pericarditis	18.31	16.54	4	23262	104232	79616890
Neuralgia	18.26	16.54	34	23232	33350	79687772
Arthropathy	18.15	16.54	15	23251	177096	79544026
Frustration tolerance decreased	18.02	16.54	16	23250	7486	79713636
Blood pressure diastolic abnormal	18.00	16.54	25	23241	19177	79701945
Aspartate aminotransferase increased	17.95	16.54	9	23257	138632	79582490
Anaemia	17.94	16.54	68	23198	444947	79276175
Obstruction	17.84	16.54	13	23253	4597	79716525
Pulmonary function test decreased	17.78	16.54	16	23250	7621	79713501
Stenotrophomonas infection	17.77	16.54	12	23254	3761	79717361
Autism spectrum disorder	17.70	16.54	8	23258	1144	79719978
Blood pressure systolic increased	17.48	16.54	51	23215	66935	79654187
Fall	17.48	16.54	78	23188	487551	79233571
Condition aggravated	17.47	16.54	223	23043	500901	79220221
Coma	17.41	16.54	4	23262	100645	79620477
Cerebrovascular accident	17.39	16.54	12	23254	155280	79565842
Therapy non-responder	17.36	16.54	3	23263	92302	79628820
Hyposmia	17.34	16.54	7	23259	758	79720364
Hypophosphataemia	17.30	16.54	25	23241	19888	79701234
Malaise	17.08	16.54	218	23048	489651	79231471
Hepatic enzyme increased	16.89	16.54	17	23249	182593	79538529
Nasal septum deviation	16.76	16.54	9	23257	1864	79719258
Atrial fibrillation	16.56	16.54	20	23246	197866	79523256

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D07AC17	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	R01AD08	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R01AD12	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R01AD58	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03AK06	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK10	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL08	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03BA05	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
ATC	R03BA09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
CHEBI has role	CHEBI:50857	anti-allergic drugs
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D001993	Bronchodilator Agents
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D019141	Respiratory System Agents
CHEBI has role	CHEBI:50266	Prodrugs

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Chronic obstructive lung disease	indication	13645005	DOID:3083
Allergic rhinitis	indication	61582004
Chronic bronchitis	indication	63480004	DOID:6132
Pulmonary emphysema	indication	87433001
Asthma	indication	195967001	DOID:2841
Chronic Non-Allergic Rhinitis	indication
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282
Epistaxis	contraindication	12441001
Measles	contraindication	14189004	DOID:8622
Disease caused by parasite	contraindication	17322007
Glaucoma	contraindication	23986001	DOID:1686
Viral disease	contraindication	34014006	DOID:934
Hypercortisolism	contraindication	47270006
Perforation of nasal septum	contraindication	80142000
Bacterial infectious disease	contraindication	87628006
Operation on nose	contraindication	88733004
Bilateral cataracts	contraindication	95722004
Pulmonary tuberculosis	contraindication	154283005	DOID:2957
Ophthalmic herpes simplex	contraindication	186542001
Varicella-zoster virus infection	contraindication	309465005
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Exposure to varicella	contraindication	444453009
Nasal Candidiasis	contraindication
Nasal Trauma	contraindication
Nasal Septal Ulcers	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.49	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	RE44874	March 23, 2023	FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	RE44874	March 23, 2023	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	RE44874	March 23, 2023	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	RE44874	March 23, 2023	INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	RE44874	March 23, 2023	INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 9, 2020	RX	POWDER	INHALATION	RE44874	March 23, 2023	INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	8309572	April 27, 2025	METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 9, 2020	RX	POWDER	INHALATION	8309572	April 27, 2025	METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
0.05MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 12, 2023	RX	POWDER	INHALATION	7439393	May 21, 2025	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	7439393	May 21, 2025	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	7439393	May 21, 2025	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	7439393	May 21, 2025	INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	7439393	May 21, 2025	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 9, 2020	RX	POWDER	INHALATION	7439393	May 21, 2025	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	8183257	July 27, 2025	METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA INHALATION
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	8183257	July 27, 2025	METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 9, 2020	RX	POWDER	INHALATION	8183257	July 27, 2025	METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
0.05MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 12, 2023	RX	POWDER	INHALATION	8511304	June 14, 2027	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	8511304	June 14, 2027	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	8511304	June 14, 2027	LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	8511304	June 14, 2027	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	8511304	June 14, 2027	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	8511304	June 14, 2027	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	8511304	June 14, 2027	METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 9, 2020	RX	POWDER	INHALATION	8511304	June 14, 2027	METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD
0.05MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 12, 2023	RX	POWDER	INHALATION	11116721	Feb. 26, 2029	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	11116721	Feb. 26, 2029	INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	11116721	Feb. 26, 2029	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	11116721	Feb. 26, 2029	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	11116721	Feb. 26, 2029	INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	April 30, 2015	RX	POWDER	INHALATION	11116721	Feb. 26, 2029	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	11090294	Nov. 29, 2030	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 18, 2017	RX	POWDER	INHALATION	Sept. 9, 2023	MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	TRELEGY ELLIPTA	GLAXOSMITHKLINE	N209482	Sept. 9, 2020	RX	POWDER	INHALATION	Sept. 9, 2023	NEW STRENGTH
0.05MG/INH	ARNUITY ELLIPTA	GLAXOSMITHKLINE	N205625	May 17, 2018	RX	POWDER	INHALATION	March 1, 2026	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OFSTUDY HZA114971
0.05MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 12, 2023	RX	POWDER	INHALATION	May 13, 2026	NEW STRENGTH
0.1MG/INH;EQ 0.025MG BASE/INH	BREO ELLIPTA	GLAXO GRP LTD	N204275	May 10, 2013	RX	POWDER	INHALATION	May 13, 2026	NEW PATIENT POPULATION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	IC50	10.12	CHEMBL	CHEMBL
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN		IC50	6.83	CHEMBL
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN		IC50	7.68	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		IC50	5.73	CHEMBL
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	8.30	CHEMBL

External reference:

ID	Source
D06315	KEGG_DRUG
4026165	VUID
N0000179800	NUI
4020529	VANDF
4026165	VANDF
CHEBI:74899	CHEBI
CHEBI:5134	CHEBI
GW6	PDB_CHEM_ID
CHEMBL1676	ChEMBL_ID
C523187	MESH_SUPPLEMENTAL_RECORD_UI
10892	IUPHAR_LIGAND_ID
8521	INN_ID
DB08906	DRUGBANK_ID
JS86977WNV	UNII
DB13867	DRUGBANK_ID
41126	RXNORM
109674	MMSL
23848	MMSL
51966	MMSL
d01296	MMSL
004952	NDDF
012173	NDDF
108632003	SNOMEDCT_US
397192001	SNOMEDCT_US
426409006	SNOMEDCT_US
C1948374	UMLSCUI
C0082607	UMLSCUI
CHEMBL1201396	ChEMBL_ID
9854489	PUBCHEM_CID
5636	INN_ID
90566-53-3	SECONDARY_CAS_RN
5311101	PUBCHEM_CID
D000068298	MESH_DESCRIPTOR_UI
6699	IUPHAR_LIGAND_ID
CUT2W21N7U	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FLONASE SENSIMISTALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	0135-0615	SPRAY, METERED	27.50 ug	NASAL	NDA	16 sections
FLONASE SENSIMISTALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	0135-0615	SPRAY, METERED	27.50 ug	NASAL	NDA	16 sections
FLONASE SENSIMISTALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	0135-0616	SPRAY, METERED	27.50 ug	NASAL	NDA	16 sections
FLONASE SENSIMISTALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	0135-0616	SPRAY, METERED	27.50 ug	NASAL	NDA	16 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0859	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0859	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0859	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0874	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0874	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0874	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0876	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0876	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0876	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0882	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0882	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0882	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Trelegy Ellipta	HUMAN PRESCRIPTION DRUG LABEL	3	0173-0887	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Trelegy Ellipta	HUMAN PRESCRIPTION DRUG LABEL	3	0173-0887	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Trelegy Ellipta	HUMAN PRESCRIPTION DRUG LABEL	3	0173-0887	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0888	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0888	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Arnuity Ellipta	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0888	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Trelegy Ellipta	HUMAN PRESCRIPTION DRUG LABEL	3	0173-0893	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Trelegy Ellipta	HUMAN PRESCRIPTION DRUG LABEL	3	0173-0893	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Trelegy Ellipta	HUMAN PRESCRIPTION DRUG LABEL	3	0173-0893	POWDER	200 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Breo Ellipta	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0916	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
FLONASE SENSIMISTALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	50090-5967	SPRAY, METERED	27.50 ug	NASAL	NDA	17 sections
FLONASE SENSIMISTALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	50090-6075	SPRAY, METERED	27.50 ug	NASAL	NDA	17 sections
Veramyst	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6168	SPRAY, METERED	27.50 ug	NASAL	NDA	27 sections
Fluticasone Furoate and Vilanterol	HUMAN PRESCRIPTION DRUG LABEL	2	66993-135	POWDER	100 ug	RESPIRATORY (INHALATION)	NDA authorized generic	26 sections