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sultiame
sultiame is a Biologic drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 2 development.
Sultiame, also known as sulthiame, is a small molecule that inhibits the enzyme carbonic anhydrase. It is used as an anticonvulsant in the treatment of epilepsy and has shown promise in reducing symptoms of obstructive sleep apnea.
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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 | sultiame |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Target | Carbonic anhydrase 1, Carbonic anhydrase 2, Carbonic anhydrase 6 |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes
- Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA) (PHASE2)
- Pharmacokinetics and Tolerability of Sulthiame (PHASE1)
- HEAD-Study Optimizing the Treatment of Children With BECTS (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:
- sultiame CI brief — competitive landscape report
- sultiame updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about sultiame
What is sultiame?
Who makes sultiame?
What development phase is sultiame in?
What does sultiame target?
Related
- Target: All drugs targeting Carbonic anhydrase 1, Carbonic anhydrase 2, Carbonic anhydrase 6
- 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