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Palvella Therapeutics

HQ: Wayne, PA source · palvellatx.com ↗ · Mid-Atlantic

Clinical Phase 3

Palvella Therapeutics is a biotechnology company developing and commercializing medicines for patients with rare dermatological diseases. From company website Source · checked 2026-10-19

Sources for this description (1)
  • Palvella Therapeutics is a biotechnology company developing and commercializing medicines for patients with rare dermatological diseases.
    • “Palvella Therapeutics is a biotechnology company specializing in developing and commercializing medicines for patients with rare dermatological diseases.” https://www.palvellatx.com/ (2026-10-19)

Regulatory: Breakthrough Therapy Designation Fast Track Designation

Keywords: dermatology Pachyonychia Congenita Microcystic Lymphatic Malformation Angiokeratomas Cutaneous Venous Malformations PTX-022

Location: Wayne, PA · source · Oct 14, 2026

Profile checked Oct 10, 2026

$230.0MRaised (2 yrs)9Trials (company is sponsor)3NIH grants

Funding and NIH signals

Job counts as of Oct 18, 2026. All funding and NIH signals

Timeline

  1. Trial start 2: A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU) source ↗
  2. Raise Follow-on offering: $230M (total, as published), announced Mar 2, 2026. Source: company release on GlobeNewswire. source ↗
  3. Grant Government grant: $2.6M (up to, as announced), announced Jun 9, 2025. Source: company release on GlobeNewswire. source ↗
  4. Trial start 2: A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations source ↗
  5. Trial start 3: SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations source ↗
  6. Trial start Phase 3: A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita source ↗
  7. Trial start Phase 2: Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations source ↗
  8. Trial start 3: A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita source ↗
  9. Trial start Phase 2: CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome source ↗
  10. Trial start Phase 3: VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita source ↗
  11. Trial start 2: Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $230.0M. Last 2 years.

Clinical trials (lead sponsor) 9

RecordTitlePhaseStatusStartPrimary completion
NCT07552077A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)2Recruiting2026-042027-08 (estimated)
NCT06239480SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations3Active, not recruitingJul 31, 2024Jan 14, 2026 (actual)
NCT06653842A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations2Active, not recruitingDec 20, 2024Nov 21, 2025 (actual)
NCT05050149Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic MalformationsPhase 2CompletedJan 13, 2022Nov 15, 2022 (actual)
NCT04893486CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin SyndromePhase 2CompletedMay 6, 2021Mar 13, 2023 (actual)
NCT04520750VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia CongenitaPhase 3CompletedSep 1, 2020Jun 30, 2021 (actual)
NCT03920228Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita2CompletedApr 1, 2019Sep 19, 2020 (actual)
NCT05180708A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita3CompletedNov 29, 2021Jun 30, 2023 (actual)
NCT05643872A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia CongenitaPhase 3RecruitingNov 15, 20222023-10 (estimated)

NIH awards 3

Annual award amounts. Total $1.6M.

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