This section highlights FDA-related milestones and regulatory updates for drugs developed by Quoin Pharmaceuticals (QNRX).
Over the past two years, Quoin Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
QRX003 and QRX009. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
QRX003 FDA Regulatory Timeline and Events
QRX003 is a drug developed by Quoin Pharmaceuticals for the following indication: Nethertons Syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- QRX003
- Announced Date:
- August 28, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients with Netherton Syndrome.
Read Announcement- Drug:
- QRX003
- Announced Date:
- July 9, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for QRX003 for the treatment of Peeling Skin Syndrome (PSS), enabling initiation of its planned Phase 2 clinical study.
AI Summary
Quoin Pharmaceuticals Ltd. said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for QRX003, allowing the company to begin its planned Phase 2 clinical study for Peeling Skin Syndrome (PSS). The study is expected to include 6 to 8 pediatric and adult patients in the United States and Europe. QRX003 will be applied twice daily to more than 80% of patients’ body surface area for 52 weeks. PSS is a rare inherited skin disorder that causes the top layer of skin to peel off too easily, often leading to severe pain and long-lasting itching. There is currently no approved treatment for the disease. Quoin says it is aiming for possible approval of QRX003 as a treatment for PSS in 2028.
Read Announcement- Drug:
- QRX003
- Announced Date:
- June 23, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd announced that the U.S. Food and Drug Administration (FDA) has conditionally approved QYLEKI™ as the proposed brand name for QRX003, the Company’s investigational product candidate for the treatment of Netherton Syndrome.
AI Summary
Quoin Pharmaceuticals Ltd. said the U.S. Food and Drug Administration has conditionally approved QYLEKI™ as the proposed brand name for QRX003, the company’s investigational treatment for Netherton Syndrome. The name is pronounced “Key-Lek-ee” and was developed to follow the FDA’s rules for proprietary drug names. This step gives the company a clearer path for branding the product as it moves through the regulatory process.
However, the brand name is not final yet. Full approval of QYLEKI will depend on the FDA granting marketing approval for QRX003. Quoin said the naming decision is an important part of the product’s development as it works toward making the treatment available for patients with this rare skin condition.
Read Announcement- Drug:
- QRX003
- Announced Date:
- June 2, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for QRX003 for the treatment of Peeling Skin Syndrome (PSS). Pending FDA review, Quoin expects to initiate a Phase 2 clinical study in the second half of 2026.
AI Summary
Quoin Pharmaceuticals Ltd. announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for QRX003, a possible treatment for Peeling Skin Syndrome (PSS). If the FDA review goes well, the company expects to begin a Phase 2 clinical study in the second half of 2026.
Quoin said this is the first IND submission ever for PSS, a rare disease that currently has no approved treatment or cure. The filing was supported by positive early clinical data from an investigator-led pediatric study.
PSS would be the second indication for QRX003, alongside Netherton Syndrome. Quoin said the goal is to move the program forward and give patients with this serious skin disorder a much-needed treatment option.
Read Announcement- Drug:
- QRX003
- Announced Date:
- March 25, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. today provided a clinical and regulatory update from its recent constructive Type C meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome (NS).
AI Summary
Quoin Pharmaceuticals reported a constructive Type C meeting with the U.S. Food and Drug Administration about its lead candidate, QRX003, for treating Netherton Syndrome. The FDA indicated that a single Phase 3 study may be sufficient to support U.S. marketing approval. Regulators were also open to an alternative Phase 3 design that likely would not include a traditional upfront vehicle or placebo control, which could reduce patient exposure to non-active treatments and streamline the study.
Quoin said it remains on track to start the Phase 3 trial and to complete patient recruitment in 2026, with a potential New Drug Application (NDA) filing in 2027. The company described the meeting as constructive and focused on aligning clinical and regulatory plans to move QRX003 toward approval for this rare skin disorder.
Read Announcement- Drug:
- QRX003
- Announced Date:
- March 11, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.
AI Summary
Quoin Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder that currently has no approved therapies. The designation signals regulatory support to speed development of this potential treatment for a serious condition with an unmet medical need.
QRX003 is being evaluated in two late-stage whole-body clinical trials designed to assess safety and effectiveness in people with Netherton Syndrome. Fast Track status can allow Quoin to interact more frequently with the FDA, submit portions of its application ahead of a complete file (rolling review), and potentially qualify for Accelerated Approval or Priority Review if the product meets the necessary criteria.
The Fast Track designation may help accelerate the development and review timelines for QRX003 as Quoin continues its clinical program.
Read Announcement- Drug:
- QRX003
- Announced Date:
- January 27, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that following a successful meeting with the Japanese MHLW that it has submitted an application for Orphan Drug Designation (ODD) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome.
AI Summary
Quoin Pharmaceuticals announced that, after a successful meeting with Japan’s Ministry of Health, Labour and Welfare (MHLW), it has submitted an application for Orphan Drug Designation (ODD) for its lead candidate QRX003 to treat Netherton Syndrome. The MHLW confirmed QRX003 qualifies for both ODD and Fast Track regulatory review in Japan. If granted, ODD can provide benefits such as R&D subsidies, tax credits for qualified clinical testing, reduced MHLW application fees, priority review and up to ten years of market exclusivity.
Quoin said it is beginning to set up a Japanese subsidiary to support self-commercialization of QRX003 in Japan if approved. QRX003 lotion (4%) is being tested in two late-stage whole-body pivotal trials; enrollment is expected to finish in the first half of 2026, top-line results are anticipated in the second half of 2026, and a New Drug Application submission is planned later in 2026 or early 2027.
Read Announcement- Drug:
- QRX003
- Announced Date:
- January 20, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that it has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead investigational, late-stage topical product candidate for the treatment of Netherton Syndrome.
AI Summary
Quoin Pharmaceuticals said it has filed for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead late-stage topical candidate for Netherton Syndrome. The company says QRX003 could become the first approved treatment for this rare and severe skin disorder if regulatory review is successful.
The SFDA program speeds development and review for medicines that address serious conditions, offer clear advantages over current care, and have a positive benefit‑risk balance. Quoin believes QRX003 meets those criteria. If the designation is granted, the drug could receive accelerated review and may reach patients in Saudi Arabia as early as the second half of 2026.
QRX003 lotion (4%) is in two late‑stage whole‑body pivotal trials; enrollment is expected to finish in the first half of 2026, with top‑line data anticipated in the second half of 2026. Quoin has a distribution partnership with Genpharm for Saudi Arabia and other MENA countries and plans to work with that partner to make the treatment available promptly if approved.
Read Announcement- Drug:
- QRX003
- Announced Date:
- October 28, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd announces recruitment of three additional patients in its investigator led pediatric Netherton Syndrome (NS) study as well as highly positive 9 month clinical data from the first pediatric patient in the study.
AI Summary
Quoin Pharmaceuticals Ltd has added three children to its investigator-led Netherton Syndrome (NS) study, with two patients in Austria and one in Ireland. Each will apply QRX003 lotion twice daily over their entire bodies for 12 weeks, then continue in a long-term extension while awaiting regulatory approval.
The first pediatric patient in the study showed complete skin healing after nine months of daily whole-body QRX003 treatment. Their Investigator’s Global Assessment score improved from 4 (severe) to 0 (clear), and itch severity fell from 5 to 0. They have slept uninterrupted without sedating medications and no longer need antibiotics, antivirals, antihistamines or steroids. No adverse events have been reported.
Quoin believes these positive results show the durability and life-changing potential of QRX003 for Netherton Syndrome, and it looks forward to insights from the three new patients.
Read Announcement- Drug:
- QRX003
- Announced Date:
- October 21, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead product candidate, QRX003, for the treatment of Netherton Syndrome.
Read Announcement- Drug:
- QRX003
- Announced Date:
- June 24, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the Company's lead asset, QRX003, for the treatment of Netherton Syndrome.
AI Summary
Quoin Pharmaceuticals Ltd. announced that the U.S. FDA has granted Rare Pediatric Disease Designation for its lead asset, QRX003, aimed at treating Netherton Syndrome—a rare genetic disorder that severely impacts infants. This designation is an important milestone because it recognizes QRX003 as a promising therapy for a serious and underserved pediatric population.
The FDA’s Rare Pediatric Disease Designation is reserved for treatments that could address life-threatening conditions in patients under 18 years old. This recognition supports Quoin’s ongoing efforts to demonstrate the safety and effectiveness of QRX003 as it completes crucial clinical studies. The company is working toward submitting a New Drug Application and hopes that QRX003 could be the first approved treatment option for Netherton Syndrome, potentially providing much-needed relief to affected children and their families.
Read Announcement- Drug:
- QRX003
- Announced Date:
- May 22, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003.
AI Summary
Quoin Pharmaceuticals Ltd. has received FDA clearance to begin a new pivotal clinical study, CL-QRX003-002, for its lead product, QRX003, aimed at treating Netherton Syndrome. This study will enroll about 12-15 subjects and will involve applying QRX003 to at least 80% of each subject's body surface area. Unlike other studies where QRX003 is used by itself, the participants in CL-QRX003-002 will continue their off-label systemic therapy during the trial. The study is designed to gather more robust safety and efficacy data to match the intended clinical use of QRX003. This initiative complements another ongoing pivotal study where QRX003 is administered as a monotherapy. Together, data from both studies may provide a strong basis for regulatory approval of QRX003 for both stand-alone and adjunct treatments for this rare and debilitating skin disease.
Read Announcement- Drug:
- QRX003
- Announced Date:
- May 14, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces positive initial clinical data from its ongoing Investigator Pediatric Peeling Skin Syndrome clinical study.
AI Summary
Quoin Pharmaceuticals Ltd. has announced positive initial clinical data from its ongoing Investigator Pediatric Peeling Skin Syndrome study. After 12 weeks of treatment with QRX003, patients showed clear improvements in skin healing compared to their baseline condition. Key clinical endpoints, including the Investigator’s Global Assessment (IGA), Modified Ichthyosis Area Severity Index (M-IASI), and Children’s Dermatology Life Quality Index (CDLQI), all demonstrated significant progress. For instance, the IGA score improved from severe to mild, indicating a meaningful reduction in disease severity.
Additionally, QRX003 was well tolerated without any reported adverse events, and patients are expected to continue treatment, with further assessments planned at the 24-week mark. These encouraging results position the study as a potential breakthrough for pediatric peeling skin syndrome, a rare genetic condition that currently has no approved treatment.
Read Announcement- Drug:
- QRX003
- Announced Date:
- April 2, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces additional highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study.
AI Summary
Quoin Pharmaceuticals Ltd. announced additional positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome study. In the trial, a pediatric patient showed almost completely healed skin after 6 weeks of daily whole-body application of QRX003. The improvements highlight the durability of treatment as the patient did not require previously needed medications such as antibiotics, antivirals, antihistamines, or glucocorticoids. Moreover, the patient’s severe pruritus was almost entirely eliminated, resulting in uninterrupted sleep—a significant breakthrough given the chronic itch and sleep disturbances typical of Netherton Syndrome.
These promising results indicate that QRX003 may be addressing the root causes of the disease rather than merely providing symptom relief. Furthermore, approval has been received to begin whole-body testing on a second pediatric patient, with plans to expand the study further to include additional subjects.
Read Announcement- Drug:
- QRX003
- Announced Date:
- March 4, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced it has filed U.S. and International patent applications for novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare diseases including microcystic lymphatic malformations, venous malformations and angiofibromas.
AI Summary
Quoin Pharmaceuticals Ltd. announced it has filed U.S. and international patent applications for new topical formulations of rapamycin (sirolimus). These formulations are being developed as potential treatments for several rare conditions, including microcystic lymphatic malformations, venous malformations, and angiofibromas. The company is using its proprietary Invisicare delivery technology, which is designed to improve the drug’s penetration deep into the dermis. By enhancing local delivery, Quoin aims to overcome past challenges that led to underperformance in clinical settings with other topical rapamycin products.
Quoin believes that combining rapamycin with this optimized delivery system may offer a more effective option for patients suffering from these rare diseases. The company also plans to move forward with regulatory submissions and clinical development for at least two of these indications later this year, potentially addressing an unmet need in current treatment options.
Read Announcement- Drug:
- QRX003
- Announced Date:
- January 23, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces further clinical evidence of the potential efficacy of QRX003 in Netherton Syndrome.
AI Summary
Quoin Pharmaceuticals Ltd. has announced new clinical evidence showing the potential effectiveness of its topical treatment, QRX003, in patients with Netherton Syndrome. In an ongoing open-label study, the first patient treated with QRX003 twice daily demonstrated clear improvements in skin symptoms during the 12-week treatment period. However, four weeks after stopping the treatment, all positive clinical benefits were completely reversed, with the patient’s condition returning to baseline levels. These findings support the idea that QRX003 works as a competitive broad-spectrum serine protease inhibitor by mimicking the function of the LEKTI protein, which is missing in Netherton Syndrome patients. The rapid reversal of benefits emphasizes that ongoing, chronic treatment with QRX003 may be necessary to maintain its effectiveness in managing the disease. This data adds to the growing clinical evidence backing QRX003 as a promising potential treatment for Netherton Syndrome.
Read Announcement- Drug:
- QRX003
- Announced Date:
- January 6, 2025
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces additional positive interim clinical data from one of its ongoing Netherton Syndrome clinical studies.
AI Summary
Quoin Pharmaceuticals Ltd recently announced additional positive interim clinical data from its ongoing Netherton Syndrome study. In this open-label trial, one subject who received twice-daily dosing of QRX003 showed clear improvements across all measured endpoints after 12 weeks of treatment. The clinical data revealed marked improvements on several scales, including a significant reduction in the Modified Ichthyosis Area of Severity Index (M-IASI) and the Worst Itch Numeric Rating Scale (WINRS), with the Investigator’s Global Assessment (IGA) showing a shift from a moderate rating at baseline to almost clear by the end of the study.
The study also noted increased patient satisfaction over time, and importantly, no safety concerns were reported. Photographs that display the improved skin appearance are available on Quoin’s website, further supporting the potential of QRX003 as a treatment for Netherton Syndrome.
Read Announcement- Drug:
- QRX003
- Announced Date:
- December 19, 2024
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003.
AI Summary
Quoin Pharmaceuticals Ltd. has received FDA clearance to start an additional clinical trial for QRX003, their topical lotion for treating Netherton Syndrome (NS). The new study will mimic real-world usage more closely by applying QRX003 over more than 80% of the body surface area, compared to previous studies that used approximately 20%. Up to eight subjects will participate by applying the lotion twice daily over a 12-week period. The study, led by Dr. Amy Paller at Northwestern University, aims to gather comprehensive data that could support QRX003's regulatory approval as a treatment for NS. This marks a significant step for Quoin, as the data from this extensive treatment trial will help build a robust evidence package to bring a much-needed therapy to those suffering from this rare skin disorder.
Read Announcement
QRX009 FDA Regulatory Events
QRX009 is a drug developed by Quoin Pharmaceuticals for the following indication: Topical Rapamycin Formulation for Rare Vascular and Skin Malformations.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- QRX009
- Announced Date:
- April 28, 2026
- Indication:
- Topical Rapamycin Formulation for Rare Vascular and Skin Malformations
Announcement
Quoin Pharmaceuticals Ltd. today provided a clinical and regulatory update for its QRX009 topical rapamycin development programs.
AI Summary
Quoin Pharmaceuticals provided a clinical and regulatory update for its QRX009 topical rapamycin program, outlining a multi-pronged development plan. The company is moving toward several investigator-led clinical studies to test QRX009 in rare skin and tumor conditions, aiming to broaden evidence for safety and effectiveness across key indications.
Quoin will initiate an investigator-led study in pachyonychia congenita led by Professor Edel O'Toole of Queen Mary University of London, a recognized expert in the disease. The company also plans investigator-led trials in Gorlin syndrome and tuberous sclerosis complex, and has built relationships with advocacy groups such as The PC Project and The Gorlin Syndrome Alliance, as well as key opinion leaders and clinical investigators.
In addition to investigator-led work, Quoin plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for an additional indication in Q3 2026. The company noted standard forward-looking statement cautions about future plans and timelines.
Read Announcement
