All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

benralizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
humanized origin	5263	1044511-01-4

Description:

Molecule

Description

Molfile Synonyms: benralizumab MEDI-563 fasenra

Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Ralpha) with a dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcɣRIII receptors on immune effectors cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC). Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Benralizumab, by binding to the IL-5Ralpha chain, reduces eosinophils through ADCC; however, the mechanism of benralizumab action in asthma has not been definitively established. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
0.54	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Jan. 8, 2018	EMA	AstraZeneca AB
Jan. 19, 2018	PMDA	AstraZeneca KK
Nov. 17, 2017	FDA	ASTRAZENECA AB

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
Asthma	389.71	22.73	300	12440	241860	90373847
Death	335.47	22.73	364	12376	456187	90159520
Eosinophil count increased	289.86	22.73	97	12643	12984	90602723
Wheezing	242.51	22.73	227	12513	237853	90377854
Cough	234.20	22.73	273	12467	368689	90247018
Dyspnoea	231.58	22.73	429	12311	880526	89735181
Eosinophilic granulomatosis with polyangiitis	192.80	22.73	49	12691	2481	90613226
Chest discomfort	121.88	22.73	122	12618	138243	90477464
Obstructive airways disorder	114.78	22.73	61	12679	25808	90589899
Headache	106.50	22.73	313	12427	862433	89753274
Device leakage	102.19	22.73	42	12698	9949	90605758
COVID-19	98.57	22.73	120	12620	168723	90446984
Inappropriate schedule of product administration	96.48	22.73	112	12628	149821	90465886
Eosinophil count abnormal	92.47	22.73	22	12718	844	90614863
Urticaria	91.19	22.73	160	12580	312574	90303133
Asthmatic crisis	88.64	22.73	25	12715	1885	90613822
Injection site pain	87.95	22.73	115	12625	173584	90442123
Incorrect dose administered by device	86.63	22.73	32	12708	5705	90610002
Full blood count abnormal	85.34	22.73	57	12683	36540	90579167
Bacterial disease carrier	84.68	22.73	24	12716	1842	90613865
Chills	80.59	22.73	96	12644	131885	90483822
Drug ineffective	73.04	22.73	384	12356	1383914	89231793
Bronchial wall thickening	72.84	22.73	22	12718	2109	90613598
Symptom recurrence	70.70	22.73	25	12715	3934	90611773
Bronchial secretion retention	65.21	22.73	23	12717	3592	90612115
Middle insomnia	61.86	22.73	35	12705	16716	90598991
Eosinophilia	60.71	22.73	42	12698	28491	90587216
Anaphylactic reaction	58.97	22.73	67	12673	87457	90528250
Spinal cord compression	58.35	22.73	23	12717	4888	90610819
Product dose omission issue	57.87	22.73	127	12613	291560	90324147
Impaired quality of life	56.25	22.73	37	12703	23107	90592600
Pruritus	54.98	22.73	184	12556	541341	90074366
Bronchospasm	52.52	22.73	34	12706	20675	90595032
Productive cough	51.93	22.73	59	12681	77004	90538703
Wrong technique in device usage process	51.20	22.73	22	12718	5813	90609894
Oropharyngeal pain	50.26	22.73	71	12669	115116	90500591
Blood immunoglobulin E increased	50.05	22.73	20	12720	4405	90611302
Sputum discoloured	48.11	22.73	32	12708	20359	90595348
Infusion related reaction	46.79	22.73	3	12737	416777	90198930
Therapeutic product effect incomplete	46.12	22.73	91	12649	193805	90421902
Drug intolerance	45.39	22.73	5	12735	447586	90168121
Nasal congestion	44.94	22.73	57	12683	83357	90532350
Sinus disorder	41.10	22.73	36	12704	34411	90581296
Wrist fracture	40.47	22.73	26	12714	15598	90600109
Arthropathy	40.05	22.73	3	12737	366239	90249468
Systemic lupus erythematosus	39.47	22.73	3	12737	361893	90253814
Device delivery system issue	38.63	22.73	13	12727	1765	90613942
Atrial flutter	38.43	22.73	22	12718	10736	90604971
Nasal polyps	38.20	22.73	22	12718	10858	90604849
Illness	37.95	22.73	52	12688	81917	90533790
Respiratory tract congestion	37.52	22.73	31	12709	27379	90588328
Rhinitis	36.18	22.73	23	12717	13549	90602158
Bronchial obstruction	35.32	22.73	12	12728	1677	90614030
Hepatic enzyme increased	34.21	22.73	5	12735	360731	90254976
Dysphonia	33.80	22.73	43	12697	63041	90552666
Throat tightness	33.55	22.73	30	12710	29454	90586253
Serum sickness	33.21	22.73	14	12726	3528	90612179
Increased bronchial secretion	32.47	22.73	12	12728	2141	90613566
Forced expiratory volume decreased	32.43	22.73	16	12724	5792	90609915
Condition aggravated	32.31	22.73	167	12573	595378	90020329
Malaise	32.27	22.73	165	12575	585821	90029886
Wound	31.69	22.73	3	12737	302977	90312730
Acute kidney injury	31.42	22.73	4	12736	320383	90295324
Upper limb fracture	30.78	22.73	25	12715	21553	90594154
Rales	30.65	22.73	22	12718	15805	90599902
Myalgia	29.98	22.73	72	12668	175053	90440654
Device use issue	29.33	22.73	13	12727	3700	90612007
Confusional state	29.20	22.73	9	12731	386196	90229511
Stomatitis	28	22.73	3	12737	274695	90341012
Decreased activity	27.26	22.73	16	12724	8176	90607531
Treatment failure	27.05	22.73	5	12735	303923	90311784
Pulmonary function test decreased	26.95	22.73	13	12727	4481	90611226
Rash pruritic	26.42	22.73	44	12696	82170	90533537
Abortion spontaneous	26.09	22.73	35	12705	54021	90561686
Rash	26.03	22.73	196	12544	795904	89819803
Drug interaction	25.82	22.73	4	12736	276449	90339258
Insurance issue	25.37	22.73	17	12723	10941	90604766
Pyrexia	25.30	22.73	169	12571	660316	89955391
Fractional exhaled nitric oxide increased	25.25	22.73	4	12736	15	90615692
Dyspnoea exertional	25.01	22.73	40	12700	72248	90543459
Herpes zoster	24.41	22.73	46	12694	94598	90521109
Drug dose omission by device	23.99	22.73	16	12724	10215	90605492
Intervertebral disc protrusion	23.93	22.73	24	12716	27172	90588535
Secretion discharge	23.91	22.73	19	12721	15877	90599830
Respiratory tract infection	23.68	22.73	35	12705	59043	90556664
Chronic eosinophilic rhinosinusitis	23.61	22.73	3	12737	0	90615707
Joint swelling	23.15	22.73	22	12718	503278	90112429
Bronchopulmonary aspergillosis allergic	22.91	22.73	11	12729	3755	90611952

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	198.78	28.91	111	4916	62203	42554105
Death	161.21	28.91	234	4793	470951	42145357
Eosinophilic granulomatosis with polyangiitis	157.73	28.91	53	4974	8585	42607723
Wheezing	115.81	28.91	75	4952	54706	42561602
Dyspnoea	106.95	28.91	188	4839	442433	42173875
Eosinophil count increased	102.90	28.91	41	4986	10722	42605586
Drug ineffective	67.90	28.91	194	4833	630003	41986305
Chest discomfort	56.37	28.91	52	4975	63564	42552744
Lower respiratory tract infection	53.58	28.91	42	4985	41164	42575144
Nasal congestion	51.70	28.91	36	4991	29465	42586843
Cough	51.05	28.91	82	4945	178021	42438287
Eosinophil count abnormal	49.94	28.91	11	5016	357	42615951
Headache	48.95	28.91	95	4932	239274	42377034
Nasal polyps	45.06	28.91	17	5010	3834	42612474
Urticaria	42.69	28.91	48	4979	73988	42542320
Product dose omission issue	37.44	28.91	66	4961	154299	42462009
Arthralgia	36.59	28.91	77	4950	205161	42411147
Inappropriate schedule of product administration	32.83	28.91	48	4979	95854	42520454
Myalgia	32.76	28.91	48	4979	96032	42520276
Caput succedaneum	30.47	28.91	6	5021	111	42616197
Sputum discoloured	29.36	28.91	17	5010	10115	42606193

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	388.97	22.35	275	11841	250016	110327167
Eosinophilic granulomatosis with polyangiitis	255.15	22.35	79	12037	10607	110566576
Wheezing	236.68	22.35	207	11909	255023	110322160
Dyspnoea	219.21	22.35	414	11702	1106458	109470725
Cough	198.51	22.35	248	11868	461393	110115790
Eosinophil count increased	195.64	22.35	77	12039	20981	110556202
Death	126.05	22.35	252	11864	698617	109878566
Chest discomfort	113.01	22.35	116	12000	173732	110403451
Obstructive airways disorder	93.61	22.35	60	12056	46089	110531094
Device leakage	93.11	22.35	42	12074	16006	110561177
Headache	90.05	22.35	255	11861	882122	109695061
Urticaria	89.74	22.35	140	11976	318717	110258466
Sputum discoloured	87.25	22.35	48	12068	27897	110549286
Bacterial disease carrier	85.95	22.35	24	12092	2245	110574938
Injection site pain	75.19	22.35	95	12021	177827	110399356
Bronchial secretion retention	70.97	22.35	25	12091	4999	110572184
Incorrect dose administered by device	70.66	22.35	27	12089	6787	110570396
Nasal congestion	70.08	22.35	69	12047	98213	110478970
Bronchial wall thickening	69.39	22.35	22	12094	3185	110573998
Asthmatic crisis	69.16	22.35	20	12096	2122	110575061
Eosinophil count abnormal	67.67	22.35	17	12099	1057	110576126
Full blood count abnormal	67.46	22.35	53	12063	55999	110521184
COVID-19	65.30	22.35	105	12011	244955	110332228
Inappropriate schedule of product administration	65.17	22.35	95	12021	203542	110373641
Chills	62.57	22.35	90	12026	190490	110386693
Impaired quality of life	58.33	22.35	38	12078	29979	110547204
Drug ineffective	56.47	22.35	320	11796	1520220	109056963
Spinal cord compression	54.32	22.35	23	12093	7529	110569654
Therapeutic product effect incomplete	53.04	22.35	91	12025	223714	110353469
Pruritus	52.35	22.35	161	11955	581399	109995784
Productive cough	51.41	22.35	63	12053	114242	110462941
Wrist fracture	51.25	22.35	27	12089	14390	110562793
Bronchial obstruction	49.99	22.35	17	12099	3062	110574121
Anaphylactic reaction	49.80	22.35	62	12054	114238	110462945
Wrong technique in device usage process	49.58	22.35	21	12095	6880	110570303
Acute kidney injury	49.08	22.35	6	12110	635424	109941759
Eosinophilia	47.60	22.35	44	12072	57892	110519291
Middle insomnia	44.92	22.35	28	12088	20474	110556709
Respiratory tract congestion	43.34	22.35	32	12084	30825	110546358
Oropharyngeal pain	41.64	22.35	62	12054	135214	110441969
Blood immunoglobulin E increased	41.56	22.35	19	12097	7463	110569720
Toxicity to various agents	41.16	22.35	3	12113	480552	110096631
Myalgia	40.81	22.35	81	12035	222300	110354883
Drug interaction	40.44	22.35	4	12112	500179	110077004
Illness	38.09	22.35	46	12070	82125	110495058
Sinus disorder	37.34	22.35	30	12086	32698	110544485
Bronchospasm	37.26	22.35	29	12087	30210	110546973
Nasal polyps	36.65	22.35	21	12095	13179	110564004
Malaise	35.83	22.35	157	11959	671662	109905521
Product dose omission issue	35.58	22.35	96	12020	321686	110255497
Device delivery system issue	35.50	22.35	12	12104	2121	110575062
Upper limb fracture	34.71	22.35	24	12092	20864	110556319
Rash pruritic	34.65	22.35	48	12068	98021	110479162
Pyrexia	31.78	22.35	187	11929	898078	109679105
Rales	31.07	22.35	24	12092	24715	110552468
Drug intolerance	30.97	22.35	4	12112	406508	110170675
Rhinitis	30.81	22.35	23	12093	22522	110554661
Lower respiratory tract infection	30.42	22.35	76	12040	243030	110334153
Rash	30.39	22.35	173	11943	820791	109756392
Pharyngeal swelling	30.38	22.35	18	12098	12014	110565169
Hypersensitivity	29.25	22.35	104	12012	403894	110173289
Anaemia	28.73	22.35	12	12104	547074	110030109
Intervertebral disc protrusion	28.68	22.35	24	12092	27674	110549509
Drug dose omission by device	27.28	22.35	18	12098	14498	110562685
Atrial flutter	27.17	22.35	22	12094	24240	110552943
Chronic obstructive pulmonary disease	26.64	22.35	45	12071	109113	110468070
Dysphonia	26.57	22.35	37	12079	75892	110501291
Device use issue	25.48	22.35	11	12105	3773	110573410
Respiratory tract infection	25.21	22.35	35	12081	71582	110505601
Confusional state	25.06	22.35	10	12106	468670	110108513
Increased bronchial secretion	25.03	22.35	11	12105	3937	110573246
Febrile neutropenia	24.40	22.35	3	12113	316764	110260419
Hyperventilation	24.21	22.35	14	12102	8933	110568250
Secretion discharge	24.04	22.35	19	12097	20225	110556958
Neutropenia	23.56	22.35	6	12110	374614	110202569
Ectopic pregnancy	23.45	22.35	9	12107	2288	110574895
Symptom recurrence	23.04	22.35	11	12105	4761	110572422
Arthralgia	22.38	22.35	154	11962	779478	109797705

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R03DX10	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Other systemic drugs for obstructive airway diseases
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D019141	Respiratory System Agents
FDA MoA	N0000193802	Interleukin 5 Receptor alpha-directed Antibody Interactions
FDA EPC	N0000193803	Interleukin-5 Receptor alpha-directed Cytolytic Antibody
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:50177	dermatologic drug
CHEBI has role	CHEBI:65023	anti-asthmatic agent

Related Drugs by ATC class:

R03DX Other systemic drugs for obstructive airway diseases 10 drugs

amlexanoxdepemokimab-ulaaeprozinolfenspiridemepolizumabomalizumabreslizumabroflumilastseratrodasttezepelumab

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

Disease	Relation	SNOMED_ID	DOID
Eosinophilic asthma	indication	367542003	DOID:9498

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Interleukin-5 receptor subunit alpha	Membrane receptor	Q01344	IL5RA_HUMAN	ANTIBODY BINDING	Kd	10.96		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
71492GE1FX	UNII
4037103	VANDF
C2982078	UMLSCUI
CHEBI:750071	CHEBI
CHEMBL1742991	ChEMBL_ID
DB12023	DRUGBANK_ID
D09874	KEGG_DRUG
9233	INN_ID
C571386	MESH_SUPPLEMENTAL_RECORD_UI
7674	IUPHAR_LIGAND_ID
763651005	SNOMEDCT_US
763652003	SNOMEDCT_US
265443	MMSL
33253	MMSL
d08675	MMSL
017409	NDDF
1989100	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FASENRA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1730	INJECTION, SOLUTION	30 mg	SUBCUTANEOUS	BLA	27 sections
FASENRA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1745	INJECTION, SOLUTION	10 mg	SUBCUTANEOUS	BLA	27 sections
FASENRA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1830	INJECTION, SOLUTION	30 mg	SUBCUTANEOUS	BLA	27 sections