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CARISBAMATE
CARISBAMATE is a carisbamate drug. It is currently in Phase 3 development.
Carisbamate is thought to modulate voltage-gated sodium channels, which are involved in the transmission of nerve impulses.
Carisbamate is being investigated as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) in children and adults. It is also being studied as a potential treatment for seizures, epilepsy, and focal seizure disorder.
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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 | CARISBAMATE |
|---|---|
| Drug class | carisbamate |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Imagine your nerves are like electrical wires that carry signals throughout your body. Carisbamate works by changing the way these wires work, which can help reduce the abnormal electrical activity that can cause seizures or other conditions.
Approved indications
Common side effects
Key clinical trials
- Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults (PHASE3)
- Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome (PHASE1)
- Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome (PHASE1)
- Bioavailability and Food Effect Study of 3 Types of Carisbamate (PHASE1)
- Carisbamate as a Potential Treatment for Alcohol Dependence (PHASE1,PHASE2)
- An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN). (PHASE2)
- Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN). (PHASE2)
- An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures (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:
- CARISBAMATE CI brief — competitive landscape report
- CARISBAMATE updates RSS · CI watch RSS
Frequently asked questions about CARISBAMATE
What is CARISBAMATE?
How does CARISBAMATE work?
What drug class is CARISBAMATE in?
What development phase is CARISBAMATE in?
Related
- Drug class: All carisbamate drugs
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing