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Phase 3 Development of QTORIN\u2122 Rapamycin for Microcystic Lymphatic Malformations and Additional High Unmet Need Clinical Indications","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase II"},{"orgOrder":0,"company":"Palvella Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Palvella Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to QTORIN\u2122 3.9% Rapamycin Anhydrous Gel (QTORIN\u2122rapamycin) for the Treatment of Microcystic Lymphatic Malformations","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 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Find Clinical Drug Pipeline Developments & Deals by Palvella Therapeutics
The partnership aims to accelerate Phase 3 development of Qtorin™ rapamycin for the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).
Qtorin (rapamycin) is a macrocyclic lactone antibiotic produced by bacteria Streptomyces hygroscopicus. It is being evaluated for the treatment of microcystic lymphatic malformations.
Qtorin (rapamycin) a topical mTOR inhibitor, which is being investigated for the treatment of microcystic lymphatic malformations and in individuals with basal cell carcinomas (BCCs) in gorlin syndrome (GS).
Qtorin (rapamycin), a topical mTOR inhibitor and the lead product candidate from the QTORIN™ platform, is being investigated in Phase 3 clinical trial for the treatment of Pachyonychia Congenita (PC).
Qtorin™ (rapamycin) is the lead product candidate from Palvella’s QTORIN™ platform and is initially under evaluation for for the treatment of individuals with Pachyonychia Congenita and Microcystic LM, as well as for the prevention of BCCs in individuals with GS.
Qtorin™ (rapamycin) is the lead product candidate from Palvella’s QTORIN™ platform and is initially under evaluation for for the treatment of individuals with Pachyonychia Congenita and Microcystic LM, as well as for the prevention of BCCs in individuals with GS.
Proceeds from the financing will be used to advance the development QTORIN rapamycin anhydrous gel for the treatment of Pachyonychia Congenita, treatment of Microcystic Lymphatic Malformations, and for the prevention of Basal Cell Carcinomas in Gorlin Syndrome.
The milestone payment comes as a result of a development funding and royalties agreement to advance their lead product candidate PTX-022 (QTORIN™ 3.9% rapamycin anhydrous gel) for the treatment of pachyonychia congenita.