MedPath

Brivaracetam

Generic Name
Brivaracetam
Brand Names
Briviact, Briviact (in Italy: Nubriveo)
Drug Type
Small Molecule
Chemical Formula
C11H20N2O2
CAS Number
357336-20-0
Unique Ingredient Identifier
U863JGG2IA

Overview

Brivaracetam is a racetam derivative of levetiracetam used in the treatment of partial-onset seizures. Brivaracetam binds SV2A with 20 times higher affinity than levetiracetam . It is available under the brand name Briviact made by UCB. Briviact received FDA approval on February 19, 2016 .

Background

Brivaracetam is a racetam derivative of levetiracetam used in the treatment of partial-onset seizures. Brivaracetam binds SV2A with 20 times higher affinity than levetiracetam . It is available under the brand name Briviact made by UCB. Briviact received FDA approval on February 19, 2016 .

Indication

Used as adjunctive therapy for partial-onset seizures in patients 16 years of age or older.

Associated Conditions

  • Partial-Onset Seizures

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/03/18
Phase 3
Recruiting
2024/03/15
Phase 1
Completed
2023/06/12
Phase 1
Not yet recruiting
2022/12/07
Phase 3
Completed
2022/11/18
Phase 1
Active, not recruiting
2022/04/07
Phase 1
Completed
2021/11/05
Phase 3
Completed
2021/09/01
Early Phase 1
Active, not recruiting
2021/05/12
Phase 1
Completed
2021/01/20
Phase 3
Recruiting

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
ORAL
75 mg in 1 1
2023/05/24
50474-670
ORAL
25 mg in 1 1
2023/05/24
50474-470
ORAL
100 mg in 1 1
2023/05/24
50474-770
ORAL
10 mg in 1 1
2023/05/24
50474-370
INTRAVENOUS
50 mg in 5 mL
2023/05/24
50474-970
ORAL
10 mg in 1 mL
2023/05/24
50474-870
ORAL
50 mg in 1 1
2023/05/24
50474-570

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision
EMEA/H/C/003898
Belgium
N/A
Authorised
2016/01/13
N/A
25

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.

No HSA products found

No HSA products found for this drug

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
国药准字H20244272
片剂
N/A
50mg
Chemical Drug
Approved
2024/06/28
Domestic
国药准字H20244271
片剂
N/A
25mg
Chemical Drug
Approved
2024/06/28
Domestic

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

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