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pp-173

Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Lennox-Gastaut syndrome (LGS) — drop seizures in children and adults Clinical stage: Phase 3 ongoing Modality: Small molecule (carbamate) Mechanism / Target: Multiple anti-seizure mechanisms — sodium channel inactivation, inhibition of T-type Ca2+ channels; glutamate receptor modulation; broad-spectrum anti-seizure activity Route / form: Oral tablet or oral suspension Differentiation: Broad multi-mechanism ASM profile potentially effective across seizure types in LGS; favourable tolerability in Phase 2; paediatric-compatible formulation; SKBP's track record with cenobamate approval
Manufacturer #39194

CNS-focused pharmaceutical company with an approved anti-epileptic and a pipeline in drug-resistant epilepsy. Develops novel anti-seizure medications for adults and children with difficult-to-treat syndromes. Wholly owned pipeline independently developed with global regulatory submissions.
 

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