Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
amide type nootrope agents, piracetam derivatives	5068	357336-20-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: brivaracetam briviact UCB 34714 UCB-34714	Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. Molecular weight: 212.29 Formula: C11H20N2O2 CLOGP: 1.01 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 63.40 ALOGS: -0.66 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

brivaracetam
briviact
UCB 34714
UCB-34714

Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

Molecular weight: 212.29
Formula: C11H20N2O2
CLOGP: 1.01
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 63.40
ALOGS: -0.66
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.10	g	O
0.10	g	P

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	0.56 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.75 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.83 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	8.98 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	700 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	100 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K21,MAP3K7,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,SIK2,STK33,SYK,TEK	30
kinase-selectivity-class	GRK2	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
Feb. 18, 2016	FDA	UCB INC
Jan. 14, 2016	EMA	UCB Pharma SA

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
Seizure	842.73	32.79	328	5481	152301	90470337
Multiple-drug resistance	358.09	32.79	86	5723	7690	90614948
Generalised tonic-clonic seizure	271.66	32.79	97	5712	34806	90587832
Status epilepticus	187.56	32.79	63	5746	18811	90603827
Off label use	182.92	32.79	282	5527	1101970	89520668
Partial seizures	179.85	32.79	49	5760	7211	90615427
Maternal exposure before pregnancy	154.58	32.79	48	5761	11165	90611473
Maternal exposure during pregnancy	149.59	32.79	147	5662	359916	90262722
Aggression	130.95	32.79	53	5756	26615	90596023
Irritability	128.88	32.79	57	5752	35605	90587033
Petit mal epilepsy	125.29	32.79	34	5775	4924	90617714
Suicidal ideation	115.62	32.79	67	5742	73788	90548850
Overdose	115.25	32.79	89	5720	157620	90465018
Behaviour disorder	108.82	32.79	30	5779	4605	90618033
Mood swings	97.70	32.79	40	5769	20662	90601976
Drug ineffective	96.82	32.79	247	5562	1384051	89238587
Anticonvulsant drug level increased	78.81	32.79	19	5790	1717	90620921
Epilepsy	70.22	32.79	51	5758	82155	90540483
Sudden unexplained death in epilepsy	67.76	32.79	13	5796	395	90622243
Product availability issue	66.78	32.79	23	5786	7381	90615257
Cognitive disorder	61.41	32.79	44	5765	69363	90553275
Somnolence	57.74	32.79	69	5740	209015	90413623
Abortion spontaneous	56.58	32.79	38	5771	54018	90568620
Depression	56.37	32.79	82	5727	300519	90322119
Seizure cluster	56.02	32.79	11	5798	378	90622260
JC polyomavirus test	55.61	32.79	8	5801	36	90622602
Mental disorder	55.02	32.79	31	5778	32287	90590351
Anger	52.99	32.79	23	5786	13697	90608941
Partial seizures with secondary generalisation	47.69	32.79	10	5799	479	90622159
Dizziness	42.61	32.79	107	5702	589177	90033461
Ataxia	41.07	32.79	21	5788	18021	90604617
Drug ineffective for unapproved indication	40.88	32.79	34	5775	66610	90556028
Postictal paralysis	40.57	32.79	8	5801	281	90622357
Gaze palsy	40.27	32.79	11	5798	1630	90621008
Focal dyscognitive seizures	37.26	32.79	12	5797	3132	90619506
Hallucination	35.05	32.79	31	5778	65928	90556710
Change in seizure presentation	34.85	32.79	8	5801	584	90622054
Aura	33.82	32.79	9	5800	1208	90621430
Hallucination, olfactory	33.77	32.79	7	5802	317	90622321
Psychogenic seizure	33.63	32.79	10	5799	2006	90620632

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
Seizure	634.02	38.42	293	4423	120268	42496351
Multiple-drug resistance	288.88	38.42	80	4636	7242	42609377
Status epilepticus	202.72	38.42	73	4643	15505	42601114
Drug ineffective	154.50	38.42	259	4457	629938	41986681
Generalised tonic-clonic seizure	133.84	38.42	63	4653	26316	42590303
Off label use	122.31	38.42	236	4480	638099	41978520
Partial seizures	121.59	38.42	39	4677	5820	42610799
Aggression	119.01	38.42	69	4647	44094	42572525
Irritability	97.79	38.42	52	4664	28076	42588543
Focal dyscognitive seizures	96.13	38.42	24	4692	1443	42615176
Aura	95.11	38.42	19	4697	406	42616213
Somnolence	91.02	38.42	94	4622	141011	42475608
Behaviour disorder	84.01	38.42	31	4685	7023	42609596
Overdose	82.45	38.42	78	4638	105186	42511433
Epilepsy	70.71	38.42	41	4675	26130	42590489
Drug level fluctuating	64.66	38.42	15	4701	659	42615960
Hyperammonaemic encephalopathy	64.00	38.42	20	4696	2738	42613881
Petit mal epilepsy	62.42	38.42	21	4695	3629	42612990
Anger	59.59	38.42	29	4687	12989	42603630
Memory impairment	59.09	38.42	47	4669	50175	42566444
Partial seizures with secondary generalisation	54.57	38.42	12	4704	413	42616206
Suicidal ideation	54.37	38.42	44	4672	48117	42568502
Psychogenic seizure	53.24	38.42	12	4704	463	42616156
Product availability issue	51.19	38.42	18	4698	3549	42613070
Affective disorder	48.94	38.42	20	4696	5940	42610679
Hydrocephalus	48.56	38.42	20	4696	6058	42610561
Tonic convulsion	46.88	38.42	14	4702	1645	42614974
Salivary hypersecretion	45.98	38.42	23	4693	10920	42605699
Therapy interrupted	45.06	38.42	29	4687	22221	42594398
Myoclonus	44.13	38.42	26	4690	17039	42599580
Prescribed overdose	39.60	38.42	22	4694	12905	42603714

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
Seizure	1000.39	31.12	431	7857	220754	110360257
Multiple-drug resistance	640.58	31.12	157	8131	13078	110567933
Generalised tonic-clonic seizure	310.65	31.12	126	8162	54554	110526457
Status epilepticus	281.10	31.12	101	8187	31470	110549541
Partial seizures	231.06	31.12	68	8220	11281	110569730
Drug ineffective	211.04	31.12	392	7896	1520148	109060863
Off label use	211.01	31.12	389	7899	1499796	109081215
Petit mal epilepsy	174.81	31.12	50	8238	7497	110573514
Behaviour disorder	166.94	31.12	51	8237	9596	110571415
Aggression	164.90	31.12	83	8205	59127	110521884
Irritability	150.92	31.12	73	8215	47736	110533275
Somnolence	142.23	31.12	141	8147	297308	110283703
Epilepsy	138.96	31.12	89	8199	100120	110480891
Overdose	123.28	31.12	117	8171	233677	110347334
Suicidal ideation	121.80	31.12	80	8208	93857	110487154
Partial seizures with secondary generalisation	118.20	31.12	24	8264	835	110580176
Mood swings	117.27	31.12	49	8239	22763	110558248
Focal dyscognitive seizures	109.67	31.12	30	8258	3819	110577192
Maternal exposure before pregnancy	103.06	31.12	33	8255	7232	110573779
Anger	88.29	31.12	38	8250	18969	110562042
Aura	84.06	31.12	19	8269	1105	110579906
Seizure cluster	84.04	31.12	18	8270	815	110580196
Sudden unexplained death in epilepsy	73.01	31.12	16	8272	807	110580204
Myoclonic epilepsy	67.59	31.12	19	8269	2672	110578339
Anticonvulsant drug level increased	66.46	31.12	19	8269	2839	110578172
Product availability issue	65.51	31.12	24	8264	7866	110573145
Hyperammonaemic encephalopathy	62.23	31.12	21	8267	5413	110575598
Myoclonus	60.28	31.12	35	8253	32963	110548048
Mental disorder	60.10	31.12	37	8251	38754	110542257
Drug resistance	58.77	31.12	42	8246	56332	110524679
Ataxia	57.84	31.12	33	8255	30075	110550936
Diplopia	57.48	31.12	37	8251	41857	110539154
Atonic seizures	57.31	31.12	14	8274	1140	110579871
Psychogenic seizure	56.24	31.12	16	8272	2348	110578663
Abnormal behaviour	54.85	31.12	35	8253	39004	110542007
JC polyomavirus test	54.00	31.12	8	8280	38	110580973
Tonic convulsion	52.10	31.12	16	8272	3058	110577953
Drug ineffective for unapproved indication	51.31	31.12	50	8238	102788	110478223
Maternal exposure during pregnancy	51.05	31.12	78	8210	254805	110326206
Erectile dysfunction	48.65	31.12	25	8263	18531	110562480
Salivary hypersecretion	47.21	31.12	24	8264	17397	110563614
Vagal nerve stimulator implantation	46.59	31.12	9	8279	241	110580770
Gaze palsy	46.37	31.12	15	8273	3392	110577619
Hydrocephalus	45.75	31.12	20	8268	10355	110570656
Postictal paralysis	43.75	31.12	10	8278	611	110580400
Dizziness	41.92	31.12	131	8157	698062	109882949
Depression	41.02	31.12	80	8208	317255	110263756
Psychotic disorder	39.90	31.12	32	8256	50905	110530106
Brain operation	39.85	31.12	10	8278	910	110580101
Dyspnoea	39.27	31.12	17	8271	1106855	109474156
Balance disorder	39.24	31.12	46	8242	116514	110464497
Cognitive disorder	38.95	31.12	40	8248	87471	110493540
Arthralgia	38.94	31.12	6	8282	779626	109801385
Pain	38.36	31.12	12	8276	954943	109626068
Memory impairment	37.63	31.12	59	8229	196885	110384126
Change in seizure presentation	35.80	31.12	9	8279	825	110580186
Simple partial seizures	33.86	31.12	9	8279	1027	110579984
Psychiatric symptom	31.88	31.12	15	8273	9198	110571813
Autoimmune aplastic anaemia	31.22	31.12	4	8284	4	110581007

FDA Adverse Event Reporting System (Pediatric)

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
Cardiac septal defect	37.58	21.83	5	9	5	113934

Pharmacologic Action:

Source	Code	Description
ATC	N03AX23	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics
MeSH PA	D000927	Anticonvulsants
MeSH PA	D002491	Central Nervous System Agents
FDA MoA	N0000192345	Epoxide Hydrolase Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35623	anticonvulsant

Related Drugs by ATC class:

N03AX Other antiepileptics 18 drugs

beclamide cannabidiol carisbamate cenobamate felbamate fenfluramine ganaxolone lacosamide lamotrigine levetiracetam perampanel phenacemide show all 18 →

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

Disease	Relation	SNOMED_ID	DOID
Partial seizure	indication	29753000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.83	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
100MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
10MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
25MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
50MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
75MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
50MG/5ML (10MG/ML)	BRIVIACT	UCB INC	N205837	May 12, 2016	RX	SOLUTION	INTRAVENOUS	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
50MG/5ML (10MG/ML)	BRIVIACT	UCB INC	N205837	May 12, 2016	RX	SOLUTION	INTRAVENOUS	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
10MG/ML	BRIVIACT	UCB INC	N205838	May 12, 2016	RX	SOLUTION	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

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
Synaptic vesicle glycoprotein 2A	Transporter	Q7L0J3	SV2A_HUMAN	MODULATOR	Ki	7.10		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Synaptic vesicle glycoprotein 2A	Transporter		SV2A_RAT	INHIBITOR	IC50	7		IUPHAR

External reference:

ID	Source
U863JGG2IA	UNII
D08879	KEGG_DRUG
4035741	VANDF
C1699861	UMLSCUI
CHEBI:133013	CHEBI
CHEMBL607400	ChEMBL_ID
9837243	PUBCHEM_CID
DB05541	DRUGBANK_ID
8642	INN_ID
C482793	MESH_SUPPLEMENTAL_RECORD_UI
9041	IUPHAR_LIGAND_ID
1739745	RXNORM
238946	MMSL
31471	MMSL
401367	MMSL
d08414	MMSL
016704	NDDF
420813001	SNOMEDCT_US
421052000	SNOMEDCT_US
VLX	PDB_CHEM_ID
U863JGG2IA	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	0121-1074	SOLUTION	10 mg	ORAL	ANDA	36 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	0121-1075	INJECTION	50 mg	INTRAVENOUS	ANDA	36 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	14335-420	INJECTION	50 mg	INTRAVENOUS	ANDA	32 sections
BRIVARACETAM	HUMAN PRESCRIPTION DRUG LABEL	1	42571-370	INJECTION	50 mg	INTRAVENOUS	ANDA	30 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	50228-556	TABLET, FILM COATED	10 mg	ORAL	ANDA	36 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	50228-557	TABLET, FILM COATED	25 mg	ORAL	ANDA	36 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	50228-558	TABLET, FILM COATED	50 mg	ORAL	ANDA	36 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	50228-559	TABLET, FILM COATED	75 mg	ORAL	ANDA	36 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	50228-560	TABLET, FILM COATED	100 mg	ORAL	ANDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-370	TABLET, FILM COATED	10 mg	ORAL	NDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-470	TABLET, FILM COATED	25 mg	ORAL	NDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-570	TABLET, FILM COATED	50 mg	ORAL	NDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-670	TABLET, FILM COATED	75 mg	ORAL	NDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-770	TABLET, FILM COATED	100 mg	ORAL	NDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-870	SOLUTION	10 mg	ORAL	NDA	36 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-970	INJECTION, SUSPENSION	50 mg	INTRAVENOUS	NDA	36 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4723	TABLET	10 mg	ORAL	ANDA	32 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4724	TABLET	25 mg	ORAL	ANDA	32 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4725	TABLET	50 mg	ORAL	ANDA	32 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4726	TABLET	75 mg	ORAL	ANDA	32 sections
Brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4727	TABLET	100 mg	ORAL	ANDA	32 sections
Brivaracetam Oral Solution	Human Prescription Drug Label	1	67877-904	SOLUTION	10 mg	ORAL	ANDA	30 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1584	TABLET, FILM COATED	10 mg	ORAL	ANDA	31 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1585	TABLET, FILM COATED	25 mg	ORAL	ANDA	31 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1586	TABLET, FILM COATED	50 mg	ORAL	ANDA	31 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1587	TABLET, FILM COATED	75 mg	ORAL	ANDA	31 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1588	TABLET, FILM COATED	100 mg	ORAL	ANDA	31 sections
BRIVARACETAM	HUMAN PRESCRIPTION DRUG LABEL	1	70748-411	SOLUTION	10 mg	ORAL	ANDA	30 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1754	TABLET, FILM COATED	10 mg	ORAL	ANDA	2 sections
brivaracetam	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1755	TABLET, FILM COATED	25 mg	ORAL	ANDA	2 sections

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brivaracetam 🐶 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: