Palvella Therapeutics (PI6) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Qtorin 3.9% Rapamycin Anhydrous Gel | Cutaneous Venous Malformations | Phase II | Recruiting | 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 | Oct 17, 2024 | ― |
| Qtorin 3.9% Rapamycin Anhydrous Gel | Microcystic Lymphatic Malformation | Phase III | Recruiting | SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations | Jan 16, 2024 | ― |
| Ptx-022 | Microcystic Lymphatic Malformation | Phase II | Completed | Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations | Sep 08, 2021 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Qtorin 3.9% Rapamycin Anhydrous Gel | Phase II | Cutaneous Venous Malformations | Recruiting | 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 | Oct 17, 2024 | ― |
| Qtorin 3.9% Rapamycin Anhydrous Gel | Phase III | Microcystic Lymphatic Malformation | Recruiting | SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations | Jan 16, 2024 | ― |
| Ptx-022 | Phase II | Microcystic Lymphatic Malformation | Completed | Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations | Sep 08, 2021 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Palvella Therapeutics, Inc. (DE:PI6) have in its pipeline
Palvella Therapeutics DE:PI6 is currently developing the following drugs: Qtorin 3.9% Rapamycin Anhydrous Gel, Ptx-022. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
