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ALY 301

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Drug Profile

ALY 301

Alternative Names: ALY-301; GTX-B001

Latest Information Update: 24 Sep 2025

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At a glance

  • Originator Alys Pharmaceuticals
  • Class Bispecific antibodies; Skin disorder therapies
  • Mechanism of Action Stem cell factor inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Cold Urticaria
  • Preclinical Chronic urticaria

Most Recent Events

  • 29 Aug 2025 Phase-I clinical trials in Cold Urticaria in Germany (IV) (CTIS2025-522126-13-00) (NCT07181369)
  • 10 Jun 2025 Preclinical trials in Chronic-urticaria in USA (SC)
  • 10 Jun 2025 Alys Pharmaceuticals files an CTA for phase I/Ib trial with the Germany's Paul-Ehrlich-Institut in Germany for Chronic urticaria

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