Drugs / QRX003
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT07538583 | Mar 2026 → Jan 2027 expected | Netherton syndrome | Quoin Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06953466 | Jul 2025 → Jul 2026 overdue | Netherton syndrome | Quoin Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05789056 | Mar 2023 → Dec 2025 overdue | Netherton syndrome | Quoin Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05521438 | Jun 2022 → Dec 2025 overdue | Netherton syndrome | Quoin Pharmaceuticals | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Announces FDA Grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome quoinpharma.com ↗
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today 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 Peeling Skin Syndrome (PSS). |
| 2026-08-28 | Quoin Pharmaceuticals | Results Quoin Pharmaceuticals Reports Positive Interim Data from Ongoing Phase 2/3 Study of QRX003 in Netherton Syndrome quoinpharma.com ↗
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients with Netherton Syndrome. |
| 2026-08-14 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2026 Financial Results quoinpharma.com ↗
Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome |
| 2026-07-09 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Receives FDA IND Clearance to Initiate Phase 2 Study of QRX003 in Peeling Skin Syndrome quoinpharma.com ↗ |
| 2026-06-23 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome quoinpharma.com ↗ |
| 2026-06-16 | Quoin Pharmaceuticals | Results Quoin Pharmaceuticals Announces Positive Clinical Update from Ongoing Pediatric Netherton Syndrome Compassionate Use Program quoinpharma.com ↗
Four of the six children in the study were classified as ‘Improved’ or ‘Significantly Improved’ from baseline across key clinical endpoints at the time of this release. |
| 2026-06-04 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Announces Japan's MHLW Grants Orphan Drug Designation for QRX003 in Netherton Syndrome quoinpharma.com ↗
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation to QRX003 for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments. |
| 2026-06-02 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Submits IND Application for QRX003 in Peeling Skin Syndrome quoinpharma.com ↗ |
| 2026-03-25 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Provides Clinical and Regulatory Update from Constructive Type C Meeting with U.S. FDA for QRX003 in Netherton Syndrome quoinpharma.com ↗
FDA acknowledged that a single Phase 3 study may be sufficient to support U.S. marketing approval of QRX003 for Netherton Syndrome, rather than the two Phase 3 studies the Company had originally contemplated. |
| 2026-03-11 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome quoinpharma.com ↗ |
| 2026-01-27 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Announces Submission to Japanese MHLW for Orphan Drug Designation for QRX003 in Netherton Syndrome quoinpharma.com ↗
At the meeting, the MHLW confirmed that QRX003 qualifies for both ODD and Fast Track regulatory review in Japan. |
| 2026-01-20 | Quoin Pharmaceuticals | Regulatory Quoin Pharmaceuticals Files Breakthrough Medicine Designation Application in Saudi Arabia for QRX003 in Netherton Syndrome quoinpharma.com ↗ |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | QRX003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05521438 ↗ |
| Action | Inhibit | “serine protease inhibitor” NCT05521438 ↗ |
| Route | Topical | “QRX003Topical Lotion” NCT05521438 ↗ |