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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: 07 Apr 2026

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At a glance

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

Most Recent Events

  • 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.
  • 27 Jan 2026 According to a Quoin Pharmaceuticals media release, enrollment completion expected in H1 2026. NDA submission is planned later in the year or early 2027.
  • 21 Oct 2025 According to a Quoin Pharmaceuticals media release, enrollment in this pivotal study is expected to be completed in Q1 2026, top-line data is anticipated in the second half of 2026, and NDA submission is planned later in the year.

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