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Brivaracetam bolus
Brivaracetam bolus is a Antiepileptic agent; SV2A ligand Small molecule drug developed by UCB Pharma. It is currently in Phase 3 development for Adjunctive treatment of partial-onset seizures in patients with epilepsy, Acute seizure management (intravenous bolus formulation).
Brivaracetam is a selective synaptic vesicle protein 2A (SV2A) ligand that modulates neurotransmitter release to reduce seizure activity.
Brivaracetam is a small molecule modulator of synaptic vesicle glycoprotein 2A, classified as a drug in the MODULATOR class. It has been studied as a treatment for epilepsy, including increased seizure activity in an epilepsy monitoring unit setting, and as an intervention in clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Brivaracetam bolus |
|---|---|
| Sponsor | UCB Pharma |
| Drug class | Antiepileptic agent; SV2A ligand |
| Target | SV2A (Synaptic Vesicle Protein 2A) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Brivaracetam binds with high affinity and selectivity to SV2A, a protein involved in synaptic vesicle trafficking and neurotransmitter release. This binding reduces the release of excitatory neurotransmitters in the brain, thereby suppressing abnormal neuronal firing and seizure propagation. The bolus formulation provides rapid intravenous delivery for acute seizure management.
Approved indications
- Adjunctive treatment of partial-onset seizures in patients with epilepsy
- Acute seizure management (intravenous bolus formulation)
Common side effects
- Somnolence
- Dizziness
- Fatigue
- Irritability
- Behavioral changes
Key clinical trials
- A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy (PHASE2)
- A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting (PHASE2)
- Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy (PHASE3)
- Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures (PHASE2)
- Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brivaracetam bolus CI brief — competitive landscape report
- Brivaracetam bolus updates RSS · CI watch RSS
- UCB Pharma portfolio CI
Frequently asked questions about Brivaracetam bolus
What is Brivaracetam bolus?
How does Brivaracetam bolus work?
What is Brivaracetam bolus used for?
Who makes Brivaracetam bolus?
What drug class is Brivaracetam bolus in?
What development phase is Brivaracetam bolus in?
What are the side effects of Brivaracetam bolus?
What does Brivaracetam bolus target?
Related
- Drug class: All Antiepileptic agent; SV2A ligand drugs
- Target: All drugs targeting SV2A (Synaptic Vesicle Protein 2A)
- Manufacturer: UCB Pharma — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Adjunctive treatment of partial-onset seizures in patients with epilepsy
- Indication: Drugs for Acute seizure management (intravenous bolus formulation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing