FDA Events for Quoin Pharmaceuticals (QNRX)
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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- Drug:
- QRX003
- Announced Date:
- August 6, 2024
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd announced the planned initiation of an investigator-led clinical study in New Zealand to evaluate the safety and efficacy of QRX003 in a pediatric patient with Peeling Skin Syndrome (PSS).
AI Summary
Quoin Pharmaceuticals announced a new investigator-led clinical study in New Zealand to test its novel treatment, QRX003, in a pediatric patient with Peeling Skin Syndrome (PSS). PSS is a rare genetic condition characterized by significant skin peeling, severe pain, and chronic itching, and currently, there is no approved treatment available. This study is an important step for evaluating whether QRX003 can be both safe and effective for managing the symptoms of this rare disorder.
The company has already identified an initial clinical site and a pediatric participant in New Zealand and is also exploring opportunities to open additional clinical sites in other countries. This move highlights Quoin’s commitment to expanding the potential of QRX003 to treat rare and orphan diseases, providing hope for patients who have limited treatment options for conditions like PSS.
Read Announcement
Quoin Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Quoin Pharmaceuticals (QNRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Quoin Pharmaceuticals (QNRX) has reported FDA regulatory activity for QRX003.
The most recent FDA-related event for Quoin Pharmaceuticals occurred on June 24, 2025, involving QRX003. The update was categorized as "Designation Grant," with the company reporting: "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."
Currently, Quoin Pharmaceuticals has one therapy (QRX003) targeting the following condition: Nethertons Syndrome.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:QNRX) was last updated on 7/13/2025 by MarketBeat.com Staff
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