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vigabatrine
vigabatrine is a Biologic drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | vigabatrine |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance (PHASE2)
- Vigabatrin and Insulin Sensitivity (PHASE2)
- Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PHASE2)
- VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa (PHASE2)
- Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants (PHASE2, PHASE3)
- VIGAB-BIOSTAT: Neuronal Injury Panel Substudy
- A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms (PHASE3)
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:
- vigabatrine CI brief — competitive landscape report
- vigabatrine updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about vigabatrine
What is vigabatrine?
Who makes vigabatrine?
What development phase is vigabatrine in?
Related
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing