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A investigator initiated clinical study for QRX003 Netherton Syndrome (NS)

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Trial Profile

A investigator initiated clinical study for QRX003 Netherton Syndrome (NS)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2026

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At a glance

  • Drugs QRX 003 (Primary)
  • Indications Netherton Syndrome
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 04 Jun 2026 According to a Quoin Pharmaceuticals media release, pivotal Phase 3 study is expected to initiate in the second half of 2026, with potential NDA filing in 2027.
  • 07 May 2026 According to a Quoin Pharmaceuticals media release, the company remains on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to potentially file for FDA approval for QRX003 as the first treatment for Netherton Syndrome in 2027.
  • 26 Mar 2026 According to a Quoin Pharmaceuticals media release, the company had a Type C meeting with the U.S. FDA for QRX003 in NS. Quoin reported that the FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the U.S. and expressed openness to an alternative study design for Phase 3 that would likely not include a traditional upfront vehicle or placebo control. Quoin remains on track to initiate its Phase 3 Study and complete Phase 3 patient recruitment in 2026.

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