FDA clearance enables the first company-sponsored formal clinical study in peeling skin syndrome to begin, with initiation planned for the second half of 2026.
On July 9, 2026, Quoin Pharmaceuticals announced that the FDA had cleared its investigational new drug application (IND) for QRX003 for the treatment of peeling skin syndrome (PSS), enabling the company to initiate a planned phase 2 clinical study.¹ This will be the first company-sponsored formal clinical trial conducted in PSS.
Quoin expects to begin the study in the second half of 2026, with potential clinical sites, investigators, and participants already identified. The study is expected to enroll six to eight pediatric and adult patients with PSS across the USA and Europe.¹
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PSS is a group of rare, recessively inherited ichthyosiform genodermatoses characterized by excessive shedding of the superficial layers of the epidermis. Symptoms may be present from birth or develop during early childhood and, in some cases, can include blistering, erythema, pain, and chronic pruritus. Friction, heat, and other external factors may worsen the condition.²
PSS may affect the entire body, known as generalized PSS, or be limited mainly to the hands and feet, known as localized PSS. Generalized PSS can be further classified as type A, which is non-inflammatory, or type B, which is inflammatory.³ The inflammatory form is typically more severe, may involve other organ systems, and can be caused by loss-of-function variants in the corneodesmosin gene (CDSN).² There is currently no approved treatment for PSS.¹
QRX003 is an investigational topical serine protease inhibitor lotion. The 4% lotion is also being evaluated in whole-body phase 2 clinical trials in patients with Netherton syndrome, with a pivotal phase 3 study expected to begin in the second half of 2026. PSS is the second indication for which an IND for QRX003 has been cleared, following Netherton syndrome.¹
Findings from an ongoing pediatric study
QRX003 is currently being evaluated in an ongoing investigator-led pediatric study. Quoin reported that one participant achieved clinically meaningful improvements by Week 12 across several severity and quality-of-life endpoints, including the Modified Ichthyosis Area Severity Index, Investigator’s Global Assessment, and Children’s Dermatology Life Quality Index.¹
Treatment remains ongoing, and no adverse events have been reported after more than 15 months of continued QRX003 dosing.¹
Commenting on the IND clearance, Michael Myers, PhD, CEO of Quoin Pharmaceuticals, said: “For families living with Peeling Skin Syndrome, there is still no approved treatment and no other active clinical development of a potential treatment for the disease. This is what makes FDA clearance to initiate our Phase 2 study so meaningful for this community.”
He continued: “We are excited to start this Phase 2 study of QRX003 and take yet another step toward developing a treatment for another disease that has long been overlooked. This is now the second rare dermatologic indication for QRX003, and it fully reflects Quoin’s mission to provide hope to patient communities and families where none has previously existed.”¹
Next steps
Quoin plans to initiate the phase 2 PSS study in the second half of 2026. The company is also preparing for the expected initiation of a pivotal phase 3 study of QRX003 in Netherton syndrome during the same period. Quoin is targeting potential approval of QRX003 for PSS in 2028.¹
References
- Quoin Pharmaceuticals. Quoin Pharmaceuticals receives FDA IND clearance to initiate phase 2 study of QRX003 in peeling skin syndrome [Press release]. July 9, 2026. Available at: https://investors.quoinpharma.com/news-releases/news-release-details/quoin-pharmaceuticals-receives-fda-ind-clearance-initiate-phase/ (accessed July 15, 2026).
- National Organization for Rare Disorders. Peeling skin syndrome. Available at: https://rarediseases.org/rare-diseases/peeling-skin-syndrome/ (accessed July 15, 2026).
- Sarma N, Boler AK, Bhanja DC. Peeling skin syndrome in eight cases of four different families from India and Bangladesh. Indian J Dermatol Venereol Leprol. 2012;78:625–31.
Cite: FDA clears phase 2 QRX003 study in peeling skin syndrome. touchDERMATOLOGY. July 15, 2026.
Disclosure: This article was created by the touchDERMATOLOGY team utilizing AI as an editorial tool (ChatGPT [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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