Upcoming FDA Events for Skinvisible
Skinvisible (SKVI) has upcoming FDA regulatory milestones for QRX003. The table below outlines estimated target dates and event types for these pending regulatory actions.
Skinvisible's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Skinvisible (SKVI).
Over the past two years, Skinvisible 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 Skinvisible 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:
- October 20, 2026
- Target Action Date:
- Q2 2027
- Estimated Target Date Range:
- April 1, 2027 - June 30, 2027
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that the Topline Data Expected in Q2 2027
Read Announcement- Drug:
- QRX003
- Announced Date:
- October 20, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced the publication of a peer-reviewed manuscript titled "An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use Case Report" in Dermatology and Therapy.
Read Announcement- Drug:
- QRX003
- Announced Date:
- October 14, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announces that its lead product candidate QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for the treatment of Peeling Skin Syndrome.
Read Announcement- Drug:
- QRX003
- Announced Date:
- October 6, 2026
- Indication:
- Nethertons Syndrome
Announcement
Quoin Pharmaceuticals Ltd. announced that a manuscript titled "An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use Case Report" has been accepted for publication in a forthcoming issue of Dermatology and Therapy.
Read Announcement
Skinvisible FDA Events - Frequently Asked Questions
As of now, Skinvisible (SKVI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Skinvisible (SKVI) has reported FDA regulatory activity for QRX003.
The most recent FDA-related event for Skinvisible occurred on October 20, 2026, involving QRX003. The update was categorized as "Publication," with the company reporting: "Quoin Pharmaceuticals Ltd. announced the publication of a peer-reviewed manuscript titled "An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use Case Report" in Dermatology and Therapy."
Currently, Skinvisible has one therapy (QRX003) targeting the following condition: Nethertons Syndrome.
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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
FDA progress for OTCMKTS:SKVI last updated on 10/20/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
