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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
quaternary ammonium compounds	2776	10405-02-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: trospium trospium chloride relaspium	Molecular weight: 392.52 Formula: C25H30NO3 CLOGP: -1.16 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 46.53 ALOGS: -6.81 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

trospium
trospium chloride
relaspium

Molecular weight: 392.52
Formula: C25H30NO3
CLOGP: -1.16
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 46.53
ALOGS: -6.81
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
40	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	500 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	6 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.46 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	10 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	5.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	13.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.33 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5 hours	Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC,TGFBR1	15
kinase-selectivity-class	AXL,EIF2AK3,GRK2,PDK4	4
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
May 28, 2004	FDA	ALLERGAN

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
Pancreatic steatosis	165.63	20.37	36	7350	1606	90619455
Lymphatic fistula	158.45	20.37	34	7352	1427	90619634
Femoral hernia incarcerated	157.37	20.37	34	7352	1474	90619587
Wound infection pseudomonas	147.43	20.37	34	7352	1989	90619072
Aortic valve stenosis	145.77	20.37	39	7347	4201	90616860
Arterial haemorrhage	145.09	20.37	35	7351	2488	90618573
Seroma	128.54	20.37	33	7353	3027	90618034
Haemarthrosis	124.46	20.37	34	7352	3960	90617101
Tachyarrhythmia	123.04	20.37	36	7350	5370	90615691
Faecaloma	122.77	20.37	42	7344	10389	90610672
Wound dehiscence	116.09	20.37	35	7351	5787	90615274
Eructation	113.35	20.37	40	7346	10842	90610219
Diverticulum intestinal	112.25	20.37	38	7348	9104	90611957
Hepatic cyst	111.93	20.37	35	7351	6533	90614528
Urinary tract infection	103.86	20.37	126	7260	305506	90315555
Coronary artery disease	101.01	20.37	51	7335	33572	90587489
Inflammatory marker increased	100.29	20.37	35	7351	9179	90611882
Aortic arteriosclerosis	98.53	20.37	33	7353	7651	90613410
Fall	95.24	20.37	153	7233	481657	90139404
Cardiovascular disorder	94.28	20.37	37	7349	13455	90607606
Groin pain	94.25	20.37	36	7350	12177	90608884
Mitral valve incompetence	91.42	20.37	42	7344	22482	90598579
Anuria	90.92	20.37	37	7349	14781	90606280
Escherichia infection	88.41	20.37	37	7349	15858	90605203
Left ventricular dysfunction	84.46	20.37	35	7351	14634	90606427
Aplastic anaemia	84.39	20.37	34	7352	13235	90607826
Postoperative wound infection	84.00	20.37	34	7352	13392	90607669
Urinary retention	81.63	20.37	46	7340	37698	90583363
Hiatus hernia	77.72	20.37	39	7347	25322	90595739
Tricuspid valve incompetence	76.79	20.37	34	7352	16697	90604364
Hyponatraemia	75.18	20.37	72	7314	133466	90487595
Pulmonary hypertension	73.95	20.37	45	7341	42478	90578583
Haematuria	71.30	20.37	41	7345	34896	90586165
Hyperkalaemia	69.96	20.37	51	7335	64913	90556148
Myelodysplastic syndrome	69.56	20.37	34	7352	20869	90600192
Osteopenia	66.48	20.37	34	7352	22968	90598093
Cardiogenic shock	61.67	20.37	33	7353	24435	90596626
Acute kidney injury	55.44	20.37	96	7290	320291	90300770
Joint dislocation	54.92	20.37	38	7348	44544	90576517
Labelled drug-drug interaction medication error	52.38	20.37	25	7361	14557	90606504
Lactic acidosis	50.69	20.37	38	7348	50425	90570636
General physical health deterioration	48.36	20.37	96	7290	355019	90266042
Oedema peripheral	46.84	20.37	79	7307	257836	90363225
Myocardial infarction	41.36	20.37	47	7339	105925	90515136
Haematemesis	37.48	20.37	27	7359	33699	90587362
Product monitoring error	37.24	20.37	14	7372	4530	90616531
Bladder trabeculation	36.68	20.37	6	7380	54	90621007
Face oedema	36.28	20.37	23	7363	23295	90597766
Therapeutic drug monitoring analysis not performed	35.37	20.37	10	7376	1319	90619742
Gastrointestinal haemorrhage	35.17	20.37	40	7346	90208	90530853
Fracture	34.91	20.37	22	7364	22054	90599007
Dementia	33.34	20.37	22	7364	23839	90597222
Gait disturbance	32.54	20.37	68	7318	260428	90360633
Multiple sclerosis relapse	29.01	20.37	28	7358	52277	90568784
Left ventricular failure	28.77	20.37	13	7373	6687	90614374
Diabetic ketosis	28.27	20.37	7	7379	554	90620507
Psychiatric decompensation	27.53	20.37	9	7377	1934	90619127
Drug ineffective	26.77	20.37	45	7341	1384253	89236808
Portal fibrosis	25.99	20.37	6	7380	352	90620709
Dizziness	24.60	20.37	104	7282	589180	90031881
Syncope	24.52	20.37	41	7345	132622	90488439
Decreased appetite	23.75	20.37	76	7310	376464	90244597
Infusion related reaction	23.75	20.37	3	7383	416777	90204284
Distal intestinal obstruction syndrome	23.73	20.37	6	7380	517	90620544
Pain	23.58	20.37	28	7358	996313	89624748
Dysuria	23.57	20.37	22	7364	39379	90581682
Joint swelling	23.57	20.37	6	7380	503294	90117767
Spinal pain	23.16	20.37	15	7371	15752	90605309
Postmortem blood drug level increased	21.87	20.37	6	7380	709	90620352
Drug intolerance	21.61	20.37	5	7381	447586	90173475
Drug hypersensitivity	20.81	20.37	6	7380	463603	90157458

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
Product prescribing error	73.02	24.29	38	3516	26074	42591707
Anticholinergic syndrome	70.59	24.29	18	3536	1571	42616210
General physical health deterioration	70.09	24.29	74	3480	151172	42466609
Hyperkinesia	43.21	24.29	13	3541	2085	42615696
Arteriosclerotic gangrene	41.79	24.29	7	3547	72	42617709
Mucosal haemorrhage	36.47	24.29	11	3543	1779	42616002
Bladder spasm	36.27	24.29	10	3544	1177	42616604
Freezing phenomenon	35.88	24.29	11	3543	1878	42615903
Atrioventricular block second degree	34.40	24.29	13	3541	4174	42613607
Fall	34.14	24.29	66	3488	234454	42383327
Labelled drug-drug interaction medication error	33.31	24.29	19	3535	15563	42602218
Mydriasis	31.08	24.29	15	3539	8755	42609026
Confusional state	30.51	24.29	52	3502	167545	42450236
Therapeutic product effect variable	30.50	24.29	11	3543	3098	42614683
Skin swelling	27.67	24.29	10	3544	2832	42614949
Disorientation	26.68	24.29	23	3531	36366	42581415
Stress urinary incontinence	26.30	24.29	5	3549	110	42617671
Pallor	24.79	24.29	20	3534	28866	42588915
Thrombophlebitis	24.53	24.29	10	3544	3916	42613865

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
Lymphatic fistula	154.26	18.79	34	9927	1461	110577877
Femoral hernia incarcerated	153.94	18.79	34	9927	1475	110577863
Pancreatic steatosis	152.92	18.79	35	9926	1787	110577551
Wound infection pseudomonas	138.09	18.79	34	9927	2377	110576961
Arterial haemorrhage	127.19	18.79	35	9926	3784	110575554
Aortic valve stenosis	126.31	18.79	39	9922	6311	110573027
Seroma	122.76	18.79	33	9928	3268	110576070
Faecaloma	121.55	18.79	47	9914	14861	110564477
General physical health deterioration	110.68	18.79	162	9799	425133	110154205
Wound dehiscence	109.69	18.79	37	9924	7925	110571413
Tachyarrhythmia	104.46	18.79	36	9925	8225	110571113
Fall	104.33	18.79	191	9770	603291	109976047
Haemarthrosis	100.73	18.79	34	9927	7295	110572043
Eructation	99.46	18.79	40	9921	14017	110565321
Diverticulum intestinal	99.30	18.79	38	9923	11681	110567657
Hepatic cyst	98.73	18.79	34	9927	7749	110571589
Urinary retention	98.11	18.79	67	9894	69616	110509722
Urinary tract infection	97.73	18.79	133	9828	326149	110253189
Groin pain	95.86	18.79	40	9921	15388	110563950
Escherichia infection	85.15	18.79	42	9919	23774	110555564
Inflammatory marker increased	84.84	18.79	36	9925	14433	110564905
Aortic arteriosclerosis	83.91	18.79	33	9928	10905	110568433
Labelled drug-drug interaction medication error	82.53	18.79	44	9917	29258	110550080
Product prescribing error	78.58	18.79	52	9909	51279	110528059
Postoperative wound infection	75.47	18.79	34	9927	15719	110563619
Cardiovascular disorder	75.07	18.79	38	9923	22722	110556616
Anuria	72.66	18.79	38	9923	24303	110555035
Haematuria	72.57	18.79	60	9901	82945	110496393
Mitral valve incompetence	71.89	18.79	42	9919	33287	110546051
Hyponatraemia	71.66	18.79	93	9868	217560	110361778
Hiatus hernia	70.91	18.79	39	9922	27567	110551771
Osteopenia	64.37	18.79	34	9927	22175	110557163
Left ventricular dysfunction	62.58	18.79	34	9927	23459	110555879
Tricuspid valve incompetence	62.07	18.79	34	9927	23839	110555499
Aplastic anaemia	61.49	18.79	34	9927	24274	110555064
Coronary artery disease	60.96	18.79	51	9910	71639	110507699
Joint dislocation	60.63	18.79	38	9923	34152	110545186
Anticholinergic syndrome	55.46	18.79	19	9942	4261	110575077
Dementia	50.69	18.79	33	9928	31640	110547698
Myelodysplastic syndrome	47.95	18.79	34	9927	37450	110541888
Gait disturbance	46.54	18.79	87	9874	278121	110301217
Product monitoring error	45.10	18.79	20	9941	8907	110570431
Pulmonary hypertension	42.28	18.79	37	9924	55183	110524155
Distal intestinal obstruction syndrome	41.68	18.79	11	9950	1014	110578324
Arteriosclerotic gangrene	41.07	18.79	7	9954	74	110579264
Cardiogenic shock	41.07	18.79	37	9924	57301	110522037
Hyperkinesia	40.73	18.79	14	9947	3170	110576168
Lactic acidosis	39.17	18.79	45	9916	92766	110486572
Bladder spasm	38.37	18.79	13	9948	2819	110576519
Dizziness	37.69	18.79	143	9818	698050	109881288
Syncope	37.23	18.79	66	9895	202470	110376868
Disorientation	34.53	18.79	37	9924	70634	110508704
Dysuria	33.87	18.79	34	9927	60197	110519141
Mucosal haemorrhage	33.72	18.79	12	9949	3008	110576330
Bladder trabeculation	33.26	18.79	6	9955	90	110579248
Hyperkalaemia	32.70	18.79	50	9911	135746	110443592
Haematemesis	32.56	18.79	33	9928	59075	110520263
Freezing phenomenon	31.55	18.79	11	9950	2598	110576740
Therapeutic product effect variable	31.11	18.79	11	9950	2707	110576631
Atrioventricular block second degree	30.95	18.79	15	9946	8166	110571172
Myocardial infarction	30.77	18.79	59	9902	192024	110387314
Therapeutic drug monitoring analysis not performed	30.70	18.79	10	9951	1921	110577417
Pallor	30.15	18.79	31	9930	56436	110522902
Hydronephrosis	29.37	18.79	20	9941	20645	110558693
Face oedema	28.83	18.79	24	9937	33445	110545893
Fracture	28.32	18.79	21	9940	24767	110554571
Urogenital haemorrhage	28.28	18.79	8	9953	956	110578382
Subileus	28.02	18.79	13	9948	6424	110572914
Acute kidney injury	27.03	18.79	121	9840	635309	109944029
Drug ineffective	26.91	18.79	61	9900	1520479	109058859
Urinary incontinence	26.53	18.79	27	9934	48560	110530778
Drug intolerance	26.17	18.79	3	9958	406509	110172829
Orthostatic intolerance	25.79	18.79	9	9952	2132	110577206
Diabetic ketosis	24.02	18.79	7	9954	929	110578409
Pyelonephritis	23.62	18.79	19	9942	25231	110554107
Anaemia	23.11	18.79	104	9857	546982	110032356
Oedema peripheral	22.59	18.79	73	9888	328587	110250751
Joint swelling	22.58	18.79	6	9955	442839	110136499
Portal fibrosis	21.36	18.79	6	9955	699	110578639
Disturbance in attention	21.16	18.79	27	9934	61968	110517370
Left ventricular failure	21.05	18.79	13	9948	11376	110567962
Drug hypersensitivity	19.90	18.79	8	9953	454082	110125256
Pollakiuria	19.61	18.79	22	9939	44173	110535165
Mydriasis	19.31	18.79	16	9945	22141	110557197
Tachycardia	19.00	18.79	54	9907	226591	110352747
Pulmonary haematoma	18.83	18.79	4	9957	144	110579194

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A03DA06	ALIMENTARY TRACT AND METABOLISM DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS ANTISPASMODICS IN COMBINATION WITH ANALGESICS Synthetic anticholinergic agents in combination with analgesics
ATC	G04BD09	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence
ATC	N05AX50	NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Other antipsychotics
FDA MoA	N0000000125	Cholinergic Muscarinic Antagonists
MeSH PA	D010276	Parasympatholytics
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018678	Cholinergic Agents
MeSH PA	D018680	Cholinergic Antagonists
MeSH PA	D018727	Muscarinic Antagonists
MeSH PA	D064804	Urological Agents
FDA EPC	N0000175700	Cholinergic Muscarinic Antagonist
CHEBI has role	CHEBI:35476	antipsychotic agent
CHEBI has role	CHEBI:48876	muscarinic antagonist
CHEBI has role	CHEBI:53784	antispasmodic drug
CHEBI has role	CHEBI:35846	renal agent

Related Drugs by ATC class:

A03DA Synthetic anticholinergic agents in combination with analgesics 5 drugs

bevonium camylofin ciclonium pitofenone tiemonium

G04BD Drugs for urinary frequency and incontinence 13 drugs

darifenacin emepronium fesoterodine flavoxate imidafenacin meladrazine mirabegron oxybutynin propiverine solifenacin terodiline tolterodine show all 13 →

N05AX Other antipsychotics 11 drugs

aripiprazole brexpiprazole cariprazine iloperidone mosapramine paliperidone pimavanserin prothipendyl risperidone xanomeline zotepine

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

Disease	Relation	SNOMED_ID	DOID
Urgent desire to urinate	indication	75088002
Urge incontinence of urine	indication	87557004
Bladder muscle dysfunction - overactive	indication	236633002
Increased Urinary Frequency	indication
Constipation	contraindication	14760008	DOID:2089
Atony of colon	contraindication	29479008
Acute nephropathy	contraindication	58574008
Ulcerative colitis	contraindication	64766004	DOID:8577
Myasthenia gravis	contraindication	91637004	DOID:437
Gastrointestinal obstruction	contraindication	126765001
Disease of liver	contraindication	235856003	DOID:409
Bladder outflow obstruction	contraindication	236645006
Retention of urine	contraindication	267064002
Gastric retention	contraindication	307227006
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Gastrointestinal hypomotility	contraindication	421807004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.67	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
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10265311	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10369143	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10369144	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10695339	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10265311	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10369143	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10369144	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10695339	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10265311	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10369143	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10369144	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10695339	July 21, 2030	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10933020	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11452692	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11471413	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11890378	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10933020	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11452692	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11471413	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11890378	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	10933020	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11452692	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11471413	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	11890378	Sept. 27, 2039	TREATMENT OF SCHIZOPHRENIA IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
20MG;EQ 100MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	Sept. 26, 2029	NEW CHEMICAL ENTITY
20MG;EQ 50MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	Sept. 26, 2029	NEW CHEMICAL ENTITY
30MG;EQ 125MG BASE	COBENFY	BRISTOL-MYERS	N216158	Sept. 26, 2024	RX	CAPSULE	ORAL	Sept. 26, 2029	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN	ANTAGONIST	Ki	8.94	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	8.99	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	8.46	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	8.84	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	8.22	CHEMBL

External reference:

ID	Source
4021473	VUID
N0000148857	NUI
D01103	KEGG_DRUG
47608-32-2	SECONDARY_CAS_RN
4021473	VANDF
C0772089	UMLSCUI
CHEMBL1888176	ChEMBL_ID
CHEMBL3084748	ChEMBL_ID
DB00209	DRUGBANK_ID
5284632	PUBCHEM_CID
7480	IUPHAR_LIGAND_ID
C003330	MESH_SUPPLEMENTAL_RECORD_UI
T4Y8ORK057	UNII
236778	RXNORM
107689	MMSL
17758	MMSL
d04929	MMSL
006793	NDDF
006794	NDDF
326557004	SNOMEDCT_US
359380005	SNOMEDCT_US
412604005	SNOMEDCT_US
CHEBI:32270	CHEBI
3001	INN_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cobenfy	HUMAN PRESCRIPTION DRUG LABEL	2	0003-0050	CAPSULE, COATED PELLETS	20 mg	ORAL	NDA	31 sections
Cobenfy	HUMAN PRESCRIPTION DRUG LABEL	2	0003-0125	CAPSULE, COATED PELLETS	30 mg	ORAL	NDA	31 sections
Cobenfy	HUMAN PRESCRIPTION DRUG LABEL	2	0003-1100	CAPSULE, COATED PELLETS	20 mg	ORAL	NDA	31 sections
Trospium ChlorideER	HUMAN PRESCRIPTION DRUG LABEL	1	0574-0118	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	29 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0574-0145	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3636	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	26 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3636	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	26 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7059	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	23155-530	TABLET, FILM COATED	20 mg	ORAL	ANDA	20 sections
Trospium Chloride	Human Prescription Drug Label	1	33342-554	TABLET	20 mg	ORAL	ANDA	28 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	60429-098	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	26 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	62135-742	TABLET, FILM COATED	20 mg	ORAL	ANDA	19 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8457	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
Trospium ChlorideER	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8458	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	28 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	63629-9279	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	68001-427	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	26 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	68462-461	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	69097-912	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	69150-258	TABLET	20 mg	ORAL	ANDA	28 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	70010-027	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	26 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	70436-174	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	22 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	70518-4593	TABLET, FILM COATED	20 mg	ORAL	ANDA	21 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	71205-917	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	26 sections
Trospium ChlorideER	HUMAN PRESCRIPTION DRUG LABEL	1	71335-2931	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	28 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	71335-2961	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
Trospium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	71610-812	TABLET, FILM COATED	20 mg	ORAL	ANDA	21 sections
Trospium ChlorideER	HUMAN PRESCRIPTION DRUG LABEL	1	72162-1106	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	28 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	72162-1108	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	72789-348	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
TROSPIUM CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	72789-348	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: