QTORIN rapamycin
QTORIN rapamycin is an mTOR inhibitor developed by Palvella Therapeutics for microcystic lymphatic malformations and cutaneous venous malformations. The next event is Phase 3 start for QTORIN rapamycin, expected Q4 2026 (source).
- Company
- Palvella Therapeutics (PVLA) · Developer
- How it works
- MTOR inhibitor
- Approved
- Not approved in any market we track
Development by disease
| Angiokeratomas | Phase 2 |
Upcoming events
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in Q4 2026
- Q4 2026QTORIN rapamycin · Phase 3 start · Cutaneous venous malformations
Expected in H2 2026
- H2 2026QTORIN rapamycin · NDA submission · Microcystic lymphatic malformations
Expected in H1 2027
- H1 2027QTORIN rapamycin · FDA decision · Microcystic lymphatic malformations
Past results and milestones
- May 7, 2026Phase 2 LOTU trial has been initiated with first patients dosed. Topline results remain on track for H2 2027. Source
- Feb 24, 2026Phase 3 SELVA trial met its primary endpoint with statistically significant improvement on mLM-IGA (p≤0.001), met pre-specified key secondary endpoint (p≤0.001), and met all four additional secondary endpoints (all p≤0.001). Safety profile was favorable with no drug-related serious adverse events and systemic rapamycin levels consistently <2 ng/mL. Source
- Dec 15, 2025Phase 2 TOIVA trial topline results released on 2025-12-15 demonstrating statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints including cVM-IGA (mean +1.5, p≤0.001), with 73% of participants showing ≥1-point improvement at Week 12. Source
- Dec 1, 2025FDA granted Fast Track Designation to QTORIN rapamycin for clinically significant angiokeratomas in December 2025. Source