Quoin Pharmaceuticals Reaches Key Milestone With 4% Topical And 5% Patch Rapamycin Formulations, Paving Way For Clinical Trials In Rare Dermatological And Vascular Disorders

Quoin Pharmaceuticals Ltd., a late clinical-stage specialty pharmaceutical company dedicated to developing treatments for rare and orphan diseases, announced the successful achievement of target loading concentrations for its two proprietary topical rapamycin delivery technologies. The company has achieved a rapamycin concentration of 4% w/w in its topical formulation and an even higher concentration of 5% w/w in its novel dermal patch system. These advancements mark a significant milestone for Quoin’s topical rapamycin program, paving the way for the production of clinical trial and stability batches this quarter, with clinical testing expected to begin in the first half of 2026.

The company has identified initial clinical targets for these formulations, including Microcystic Lymphatic Malformations and Venous Malformations—both rare conditions for which there are currently no FDA-approved treatments or cures. By leveraging its proprietary delivery platforms, Quoin aims to address these severe, unmet medical needs with potentially first-in-class therapies.

Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals, highlighted the importance of this achievement in advancing the company’s innovation strategy. “We are very pleased to announce this very significant milestone for our topical rapamycin programs,” said Dr. Myers. “We believe that rapamycin loading concentrations of 4% and 5% in these proprietary delivery systems could potentially provide competitive advantages over other topical rapamycin formulations currently in development with similar drug loadings due to the ability of our technologies to optimize delivery of the drug at the target sites. We intend to move forward from here to initiate formal clinical development across a number of already identified indications, including Microcystic Lymphatic Malformations and Venous Malformations among others.”

Dr. Myers further emphasized the complementary nature of this development within Quoin’s broader pipeline, which includes a late-stage program for Netherton Syndrome and an active program targeting Peeling Skin Syndrome. “We view these opportunities as being very complementary to our pipeline, which includes our ongoing late-stage program in Netherton Syndrome as well as our program in Peeling Skin Syndrome,” he added. “This is a very exciting time for Quoin as we look to close out this year on a positive note with the commencement of our Netherton Syndrome pivotal studies and the recent closing of a capital raise that has provided us with the funding to complete our Netherton Syndrome studies and advance the clinical development of our Peeling Skin Syndrome and topical rapamycin programs.”

With these advancements, Quoin Pharmaceuticals continues to strengthen its position as an emerging leader in the rare disease sector. Its innovative topical and patch-based delivery systems represent a significant step forward in optimizing the therapeutic potential of rapamycin, a compound with broad clinical promise. As the company moves closer to initiating clinical trials, it remains focused on addressing areas of high unmet medical need and expanding treatment options for patients with rare dermatological and vascular conditions.