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

> **NCT07287202** · PHASE1,PHASE2 · NOT_YET_RECRUITING · sponsor: **Sovargen** · enrollment: 15 (estimated)

## Conditions studied

- Focal Cortical Dysplasia
- Tuberous Sclerosis Complex (TSC)
- Hemimegalencephaly

## Interventions

- **DRUG:** SVG103

## Key facts

- **NCT ID:** NCT07287202
- **Lead sponsor:** Sovargen
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-03
- **Primary completion:** 2026-12
- **Final completion:** 2027-06
- **Target enrollment:** 15 (ESTIMATED)
- **Last updated:** 2025-12-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07287202

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07287202, "Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT07287202. Licensed CC0.

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