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

Stem definition	Drug id	CAS RN
beta3-adrenoreceptor agonists	4382	223673-61-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: YM178 myrbetriq mirabegron	a beta-3 adrenergic agonist, relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity Molecular weight: 396.51 Formula: C21H24N4O2S CLOGP: 1.32 LIPINSKI: 0 HAC: 6 HDO: 4 TPSA: 100.27 ALOGS: -4.98 ROTB: 9 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

YM178
myrbetriq
mirabegron

a beta-3 adrenergic agonist, relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity

Molecular weight: 396.51
Formula: C21H24N4O2S
CLOGP: 1.32
LIPINSKI: 0
HAC: 6
HDO: 4
TPSA: 100.27
ALOGS: -4.98
ROTB: 9

Status: ONP

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

Drug dosage:

Dose	Unit	Route
50	mg	O

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	23.80 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	13.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.29 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	50 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
June 28, 2012	FDA	APGDI

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
Urinary retention	160.75	13.12	104	17108	26086	50561826
Intentional product misuse	138.79	13.12	120	17092	46614	50541298
Blood pressure increased	129.82	13.12	191	17021	132941	50454971
Urinary tract infection	125.32	13.12	251	16961	223769	50364143
Blepharospasm	79.85	13.12	32	17180	2916	50584996
Urinary incontinence	78.81	13.12	70	17142	28138	50559774
Fall	77.63	13.12	270	16942	334662	50253250
Memory impairment	70.33	13.12	109	17103	79251	50508661
Hypertension	68.03	13.12	191	17021	211012	50376900
Taste disorder	63.55	13.12	38	17174	8286	50579626
Drug dispensed to wrong patient	61.00	13.12	14	17198	181	50587731
Toxicity to various agents	59.87	13.12	3	17209	212496	50375416
Residual urine volume increased	58.56	13.12	10	17202	21	50587891
Dry mouth	55.21	13.12	81	17131	56097	50531815
Bladder pain	48.34	13.12	19	17193	1645	50586267
Multiple sclerosis relapse	48.20	13.12	66	17146	42898	50545014
Multiple sclerosis	47.82	13.12	46	17166	20447	50567465
Off label use	44.26	13.12	294	16918	474132	50113780
Dermatitis atopic	42.87	13.12	22	17190	3564	50584348
Kidney infection	39.86	13.12	40	17172	18706	50569206
Contraindicated product administered	39.25	13.12	3	17209	148955	50438957
Scleral discolouration	38.54	13.12	11	17201	351	50587561
Maternal exposure during pregnancy	37.49	13.12	5	17207	159773	50428139
Epilepsy	36.92	13.12	41	17171	21526	50566386
Cystitis	36.40	13.12	59	17153	44505	50543407
Pollakiuria	33.57	13.12	41	17171	23810	50564102
Palpitations	32.86	13.12	88	17124	94418	50493494
Muscular weakness	32.56	13.12	88	17124	94925	50492987
Anxiety disorder	31.28	13.12	18	17194	3655	50584257
Treatment failure	30.68	13.12	5	17207	137632	50450280
Sinonasal obstruction	30.41	13.12	8	17204	187	50587725
On and off phenomenon	30.36	13.12	13	17199	1399	50586513
Migraine	29.15	13.12	73	17139	75207	50512705
Lip disorder	28.82	13.12	12	17200	1205	50586707
Infusion related reaction	28.51	13.12	11	17201	169546	50418366
Rheumatoid arthritis	28.18	13.12	17	17195	202533	50385379
Micturition urgency	28.17	13.12	23	17189	8241	50579671
Vitamin D deficiency	27.36	13.12	26	17186	11376	50576536
Dementia	26.68	13.12	30	17182	15967	50571945
Glossodynia	26.20	13.12	4	17208	115565	50472347
Schizophrenia	26.09	13.12	21	17191	7376	50580536
Exposure during pregnancy	25.66	13.12	5	17207	121010	50466902
Therapeutic product effect decreased	24.28	13.12	8	17204	136042	50451870
Gait disturbance	24.11	13.12	108	17104	149897	50438015
Intercepted medication error	24	13.12	8	17204	431	50587481
Feeling drunk	23.61	13.12	15	17197	3638	50584274
Idiopathic orbital inflammation	23.55	13.12	6	17206	123	50587789
Nocturia	23.51	13.12	19	17193	6711	50581201
Anal incontinence	23.48	13.12	24	17188	11466	50576446
Sputum retention	23.32	13.12	8	17204	471	50587441
Antineutrophil cytoplasmic antibody increased	22.78	13.12	5	17207	52	50587860
Haemorrhoids	22.47	13.12	30	17182	19023	50568889
Dysuria	22.27	13.12	37	17175	28467	50559445
Systemic lupus erythematosus	22.22	13.12	10	17202	140612	50447300
Balance disorder	21.83	13.12	63	17149	70527	50517385
Dizziness	21.76	13.12	196	17016	346173	50241739
Bladder disorder	21.62	13.12	19	17193	7524	50580388
Hand deformity	21.54	13.12	4	17208	100195	50487717
Drug hypersensitivity	21.09	13.12	33	17179	250977	50336935
Dyspepsia	20.89	13.12	64	17148	74033	50513879
Synovitis	20.87	13.12	8	17204	123857	50464055
Metastatic neoplasm	20.81	13.12	14	17198	3740	50584172
Swelling	20.34	13.12	23	17189	200849	50387063
Constipation	20.27	13.12	120	17092	185588	50402324
Disease progression	20.24	13.12	4	17208	95862	50492050
Arrhythmia	19.48	13.12	38	17174	33094	50554818
Lung neoplasm malignant	19.22	13.12	25	17187	15459	50572453
Hypertensive crisis	19.14	13.12	23	17189	13131	50574781
Vascular stenosis	19.11	13.12	6	17206	267	50587645
Pharyngeal mass	19.08	13.12	6	17206	268	50587644
Dyskinesia	18.93	13.12	34	17178	27827	50560085
Urinary tract disorder	18.51	13.12	11	17201	2369	50585543
Hypoaesthesia	18.50	13.12	89	17123	127168	50460744
Conjunctival discolouration	18.28	13.12	4	17208	41	50587871
Paraesthesia	18.14	13.12	85	17127	120158	50467754
Lip swelling	17.86	13.12	31	17181	24705	50563207
Product blister packaging issue	17.69	13.12	5	17207	154	50587758
Neutropenia	17.21	13.12	15	17197	147950	50439962
Insomnia	17.19	13.12	110	17102	174755	50413157
Hypothyroidism	16.37	13.12	36	17176	34089	50553823
Hyperventilation	16.26	13.12	14	17198	5395	50582517
Thrombocytopenia	16.02	13.12	12	17200	127661	50460251
Persistent genital arousal disorder	15.42	13.12	5	17207	247	50587665
Muscle atrophy	14.77	13.12	14	17198	6107	50581805
Wound	14.53	13.12	9	17203	105785	50482127
VIIth nerve injury	14.38	13.12	4	17208	116	50587796
Abdominal pain upper	14.31	13.12	98	17114	159211	50428701
Neurogenic bladder	14.29	13.12	10	17202	2847	50585065
Open fracture	14.19	13.12	5	17207	319	50587593
Angina pectoris	14.15	13.12	29	17183	26159	50561753
Lymphocyte count decreased	14.06	13.12	29	17183	26278	50561634
Hyperlipidaemia	14.06	13.12	23	17189	17467	50570445
Product packaging quantity issue	14	13.12	7	17205	1073	50586839
Arthropathy	13.98	13.12	20	17192	157886	50430026
Catheter site injury	13.97	13.12	4	17208	129	50587783
Febrile neutropenia	13.85	13.12	8	17204	97659	50490253
Discomfort	13.84	13.12	10	17202	108370	50479542
Sleep apnoea syndrome	13.58	13.12	27	17185	23841	50564071

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
Urinary retention	162.14	17.18	101	7440	31797	29535189
Hallucination	124.73	17.18	98	7443	44614	29522372
Intentional product misuse	63.93	17.18	60	7481	34601	29532385
Fall	54.13	17.18	131	7410	177047	29389939
Nocturia	46.28	17.18	28	7513	8334	29558652
Platypnoea	45.33	17.18	8	7533	32	29566954
Confusional state	44.98	17.18	100	7441	127777	29439209
Urinary tract infection	43.32	17.18	71	7470	72283	29494703
Phaeochromocytoma malignant	39.80	17.18	8	7533	72	29566914
Delusion	38.78	17.18	28	7513	11188	29555798
Blood pressure increased	37.05	17.18	67	7474	73736	29493250
Micturition urgency	35.72	17.18	20	7521	5153	29561833
Urinary incontinence	35.20	17.18	31	7510	16450	29550536
Drug ineffective	31.41	17.18	178	7363	362992	29203994
Dementia	29.13	17.18	24	7517	11634	29555352
Arrhythmia	27.78	17.18	37	7504	31276	29535710
Gait disturbance	26.45	17.18	58	7483	73291	29493695
Bone marrow oedema	25.29	17.18	8	7533	489	29566497
Blood pressure systolic increased	25.14	17.18	26	7515	16819	29550167
Oesophageal dilatation	24.58	17.18	6	7535	139	29566847
Spinal cord haemorrhage	24.29	17.18	7	7534	311	29566675
Hypertensive crisis	23.56	17.18	18	7523	7830	29559156
Constipation	23.36	17.18	73	7468	114087	29452899
Pollakiuria	23.27	17.18	25	7516	16891	29550095
Extradural haematoma	22.45	17.18	9	7532	1097	29565889
Prescribed underdose	21.51	17.18	17	7524	7769	29559217
Off label use	21.21	17.18	140	7401	300660	29266326
On and off phenomenon	20.62	17.18	10	7531	1918	29565068
Orthostatic hypotension	20.47	17.18	27	7514	22602	29544384
Dropped head syndrome	19.82	17.18	5	7536	133	29566853
Toxicity to various agents	19.48	17.18	10	7531	173651	29393335
Dysuria	19.11	17.18	26	7515	22414	29544572
Cystitis interstitial	19.09	17.18	5	7536	155	29566831
Dyskinesia oesophageal	18.49	17.18	4	7537	53	29566933
Perineal pain	18.11	17.18	7	7534	775	29566211
Cerebral infarction	17.21	17.18	26	7515	24649	29542337

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
Urinary retention	181.37	13.14	138	19890	49063	64429641
Urinary tract infection	125.52	13.14	243	19785	231353	64247351
Fall	113.11	13.14	334	19694	416492	64062212
Urinary incontinence	88.45	13.14	80	19948	36071	64442633
Blood pressure increased	73.35	13.14	164	19864	172388	64306316
Hallucination	72.96	13.14	101	19927	72687	64406017
Toxicity to various agents	72.03	13.14	13	20015	363500	64115204
Blepharospasm	68.36	13.14	29	19999	3346	64475358
Memory impairment	63.17	13.14	103	19925	85579	64393125
Taste disorder	62.35	13.14	38	19990	9395	64469309
Bladder pain	55.94	13.14	21	20007	1760	64476944
Residual urine volume increased	54.51	13.14	9	20019	16	64478688
Hypertension	53.96	13.14	190	19838	259071	64219633
Drug dispensed to wrong patient	53.10	13.14	14	20014	363	64478341
Intentional product misuse	49.39	13.14	84	19944	72211	64406493
Gait disturbance	47.47	13.14	139	19889	172016	64306688
On and off phenomenon	45.62	13.14	20	20008	2499	64476205
Cystitis	43.92	13.14	60	19968	42615	64436089
Platypnoea	43.76	13.14	8	20020	32	64478672
Pollakiuria	43.00	13.14	51	19977	31479	64447225
Micturition urgency	42.47	13.14	31	19997	10328	64468376
Dry mouth	42.32	13.14	71	19957	60347	64418357
Multiple sclerosis relapse	41.08	13.14	57	19971	41078	64437626
Kidney infection	40.75	13.14	38	19990	17800	64460904
Phaeochromocytoma malignant	38.22	13.14	8	20020	72	64478632
Confusional state	36.39	13.14	169	19859	260975	64217729
Muscular weakness	36.22	13.14	104	19924	127234	64351470
Dysuria	35.75	13.14	54	19974	42003	64436701
Migraine	34.11	13.14	66	19962	62611	64416093
Nocturia	33.97	13.14	28	20000	11137	64467567
Arrhythmia	31.61	13.14	58	19970	52886	64425818
Scleral discolouration	31.20	13.14	10	20018	522	64478182
Dementia	30.67	13.14	35	19993	20731	64457973
Multiple sclerosis	29.82	13.14	33	19995	18908	64459796
Delusion	29.42	13.14	32	19996	17982	64460722
Palpitations	28.42	13.14	84	19944	104404	64374300
Prescribed underdose	27.69	13.14	31	19997	17984	64460720
Dizziness	27.17	13.14	227	19801	429936	64048768
Sinonasal obstruction	26.39	13.14	7	20021	186	64478518
Lip disorder	26.09	13.14	11	20017	1250	64477454
Constipation	25.97	13.14	140	19888	229197	64249507
Thrombocytopenia	25.92	13.14	19	20009	223782	64254922
Hypertensive crisis	25.68	13.14	30	19998	18218	64460486
Orthostatic hypotension	23.96	13.14	48	19980	46690	64432014
Hypoaesthesia	23.93	13.14	96	19932	139012	64339692
Balance disorder	23.32	13.14	68	19960	83858	64394846
Idiopathic orbital inflammation	23.28	13.14	6	20022	142	64478562
Feeling drunk	23.05	13.14	15	20013	4152	64474552
Epilepsy	22.94	13.14	39	19989	33492	64445212
Dyskinesia oesophageal	22.66	13.14	5	20023	59	64478645
Cystitis interstitial	20.54	13.14	9	20019	1123	64477581
Infusion related reaction	20.32	13.14	13	20015	164454	64314250
Anal incontinence	19.77	13.14	24	20004	15172	64463532
Pharyngeal mass	19.51	13.14	6	20022	273	64478431
Spinal cord haemorrhage	19.35	13.14	7	20021	528	64478176
Urinary tract disorder	19.01	13.14	12	20016	3154	64475550
Cardio-respiratory arrest	18.44	13.14	4	20024	98389	64380315
Hyperventilation	18.44	13.14	16	20012	6824	64471880
Oesophageal dilatation	18.31	13.14	6	20022	336	64478368
Product blister packaging issue	18.23	13.14	5	20023	151	64478553
Neutropenia	18.13	13.14	29	19999	239595	64239109
Insomnia	17.98	13.14	114	19914	197722	64280982
Therapeutic product effect decreased	17.41	13.14	7	20021	115344	64363360
Bone marrow oedema	17.23	13.14	8	20020	1142	64477562
Contraindicated product administered	17.19	13.14	6	20022	107823	64370881
Hip fracture	16.56	13.14	30	19998	27069	64451635
Amnesia	16.28	13.14	42	19986	48227	64430477
Vascular stenosis	16.20	13.14	6	20022	484	64478220
Treatment failure	16.20	13.14	8	20020	116808	64361896
Persistent genital arousal disorder	16.00	13.14	5	20023	240	64478464
Dropped head syndrome	16.00	13.14	5	20023	240	64478464
Hallucination, visual	15.99	13.14	30	19998	27804	64450900
Maternal exposure during pregnancy	15.87	13.14	5	20023	95879	64382825
Paraesthesia	15.80	13.14	83	19945	134439	64344265
Hypertonic bladder	15.79	13.14	11	20017	3407	64475297
Extradural haematoma	15.71	13.14	10	20018	2666	64476038
Sputum retention	15.56	13.14	7	20021	930	64477774
Perineal pain	15.10	13.14	7	20021	996	64477708
Somatic dysfunction	14.88	13.14	3	20025	22	64478682
Intentional medical device removal by patient	14.85	13.14	5	20023	305	64478399
Abdominal pain upper	14.77	13.14	99	19929	174931	64303773
Product use complaint	14.52	13.14	8	20020	1638	64477066
Stoma site discharge	14.36	13.14	8	20020	1674	64477030
Catheter site injury	14.34	13.14	4	20024	129	64478575
Drug hypersensitivity	14.31	13.14	33	19995	237782	64240922
Rheumatoid arthritis	14.29	13.14	18	20010	164276	64314428
Feeling abnormal	14.06	13.14	80	19948	133522	64345182
Product dose omission issue	14.02	13.14	106	19922	194641	64284063
Atrial fibrillation	13.97	13.14	96	19932	170993	64307711
Open fracture	13.72	13.14	5	20023	385	64478319
Intercepted medication error	13.69	13.14	6	20022	749	64477955
Lip swelling	13.15	13.14	30	19998	31877	64446827

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G04BD12	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058667	Adrenergic beta-3 Receptor Agonists
MeSH PA	D000318	Adrenergic beta-Agonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D064804	Urological Agents
FDA MoA	N0000182137	Cytochrome P450 2D6 Inhibitors
FDA MoA	N0000185007	Adrenergic beta3-Agonists
FDA EPC	N0000185008	beta3-Adrenergic Agonist
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000190114	Cytochrome P450 3A Inhibitors
CHEBI has role	CHEBI:35522	beta-adrenergic agonists

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

Disease	Relation	SNOMED_ID	DOID
Bladder muscle dysfunction - overactive	indication	236633002
Hypertensive disorder	contraindication	38341003	DOID:10763

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.32	acidic
pKa2	8.7	Basic
pKa3	4.93	Basic

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
25MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	8835474	Nov. 4, 2023	FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	RE44872	Nov. 4, 2023	FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	8835474	Nov. 4, 2023	FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	RE44872	Nov. 4, 2023	FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	8772315	Oct. 30, 2028	USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	8772315	Oct. 30, 2028	USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	10842780	Sept. 28, 2029	ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	10842780	Sept. 28, 2029	ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
8MG/ML	MYRBETRIQ GRANULES	APGDI	N213801	March 25, 2021	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	10058536	March 31, 2036	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER BY ADMINISTRATION OF AN EXTENDED-RELEASE SUSPENSION FORMULATION OF MIRABEGRON

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
25MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	March 25, 2024	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
50MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	March 25, 2024	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
8MG/ML	MYRBETRIQ GRANULES	APGDI	N213801	March 25, 2021	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	March 25, 2024	NEW PRODUCT
25MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Sept. 25, 2024	PEDIATRIC EXCLUSIVITY
50MG	MYRBETRIQ	APGDI	N202611	June 28, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Sept. 25, 2024	PEDIATRIC EXCLUSIVITY
8MG/ML	MYRBETRIQ GRANULES	APGDI	N213801	March 25, 2021	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	Sept. 25, 2024	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN	AGONIST	EC50	7.65		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
D09535	KEGG_DRUG
4031804	VANDF
CHEBI:65349	CHEBI
H6U	PDB_CHEM_ID
CHEMBL2095212	ChEMBL_ID
C520025	MESH_SUPPLEMENTAL_RECORD_UI
7445	IUPHAR_LIGAND_ID
8907	INN_ID
DB08893	DRUGBANK_ID
MVR3JL3B2V	UNII
9865528	PUBCHEM_CID
1300786	RXNORM
191568	MMSL
28616	MMSL
d07876	MMSL
014540	NDDF
703803006	SNOMEDCT_US
703804000	SNOMEDCT_US
C2983812	UMLSCUI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	0469-2601	TABLET, FILM COATED, EXTENDED RELEASE	25 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	0469-2601	TABLET, FILM COATED, EXTENDED RELEASE	25 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	0469-2602	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	0469-2602	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	0469-5020	GRANULE, FOR SUSPENSION, EXTENDED RELEASE	8 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	0469-5020	GRANULE, FOR SUSPENSION, EXTENDED RELEASE	8 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	55154-8712	TABLET, FILM COATED, EXTENDED RELEASE	25 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	55154-8713	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	70518-2435	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	27 sections
Myrbetriq	HUMAN PRESCRIPTION DRUG LABEL	1	70518-3158	TABLET, FILM COATED, EXTENDED RELEASE	25 mg	ORAL	NDA	27 sections