Quoin Pharmaceuticals Expands QRX009 Topical Rapamycin Pipeline

ASHBURN, Va., April 28, 2026

Quoin Pharmaceuticals Ltd. has announced a major clinical and regulatory update for its QRX009 topical rapamycin development programs, highlighting a broad multi-indication strategy targeting several rare and orphan skin diseases. The company plans to initiate multiple investigator-led clinical studies across key indications including Pachyonychia Congenita (PC), Gorlin Syndrome (GS), and Tuberous Sclerosis Complex (TSC), while also preparing to submit an Investigational New Drug (IND) application to the U.S. FDA in Q3 2026 for an additional QRX009 indication. This strategic expansion positions QRX009 as a potentially transformative platform for dermatology-focused rare disease treatment.

Multi-Pronged Clinical Expansion Across Rare Skin Diseases

Quoin’s first investigator-led clinical study will focus on Pachyonychia Congenita (PC), a rare and painful genetic skin disorder with no approved treatments or cure currently available. The study will be led by Professor Edel O’Toole of Queen Mary University of London, a globally recognized leader in PC clinical research with deep expertise in dermatology and rare skin disease trials.

The company believes that combining Professor O’Toole’s experience with Quoin’s proprietary topical rapamycin delivery system could significantly improve outcomes for PC patients compared to previous treatment approaches. The study is expected to begin in Q3 2026, representing a major step forward in expanding therapeutic options for underserved rare disease populations.

In addition to PC, Quoin also plans to launch investigator-led studies later this year for Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC), both serious genetic disorders with significant dermatological manifestations and limited treatment alternatives.

Strong Regulatory Momentum With FDA IND Filing Planned

Alongside clinical study expansion, Quoin remains on track to submit its first IND application for QRX009 to the U.S. Food and Drug Administration (FDA) for an additional indication during Q3 2026. This follows the company’s successful achievement of target rapamycin loading concentrations of 4% and 5% for its proprietary lotion and dermal patch delivery systems, strengthening confidence in the product’s clinical readiness.

According to CEO Dr. Michael Myers, QRX009 could potentially be in active clinical testing across four separate indications before the end of 2026, significantly accelerating the company’s broader development strategy. These new opportunities complement Quoin’s existing late-stage program for QRX003 in Netherton Syndrome (NS) and its advancing program for Peeling Skin Syndrome, for which an IND filing is also targeted in Q2 2026.

Building a Rare Disease Leadership Position

Quoin has also established strong relationships with key patient advocacy organizations including The PC Project and The Gorlin Syndrome Alliance, alongside leading clinicians and key opinion leaders, strengthening both patient engagement and clinical execution. This collaborative model enhances trial recruitment, real-world disease understanding, and long-term commercial positioning.

With a growing pipeline centered on QRX003 and QRX009, Quoin is building a strong specialty pharmaceutical platform focused on diseases with limited or no approved therapies. The company’s strategy reflects rising demand for targeted topical therapies in orphan dermatology, where patient need remains high and treatment options are scarce.

As 2026 progresses, Quoin Pharmaceuticals is positioning itself for what could become a transformational year, with multiple clinical milestones, regulatory submissions, and potential pivotal trial advancements that may establish the company as a leader in rare dermatology innovation and specialty biopharma development.

Source: Quoin Pharmaceuticals press release