drugset
drugset / Trial / NCT07287202

Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)

NCT07287202 ↗

Phase 1/2 Not yet recruiting 15 enrolled Sovargen
NaSingle-groupOpen-labelTreatment

Summary

This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.

Timeline

Start
2026-03
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Paxalisib Small molecule — Oral

Indications

hemimegalencephaly isolated focal cortical dysplasia type II tuberous sclerosis