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Tirbanibulin - Almirall

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Drug Profile

Tirbanibulin - Almirall

Alternative Names: ALM-14789; KLISYRI; Klisyri; KX-01; KX-2391

Latest Information Update: 23 Sep 2025

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At a glance

  • Originator Kinex Pharmaceuticals
  • Developer Almirall S.A.; Athenex; Hanmi Pharmaceutical; Kinex Pharmaceuticals; PharmaEssentia Corporation
  • Class Acetamides; Antineoplastics; Antipsoriatics; Morpholines; Phenyl ethers; Pyridines; Skin disorder therapies; Small molecules
  • Mechanism of Action Src-family kinase inhibitors; Tubulin polymerisation 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

  • Marketed Actinic keratosis
  • Phase II Psoriasis
  • Phase I/II Solid tumours
  • No development reported Prostate cancer
  • Discontinued Acute myeloid leukaemia; Photodamage; Skin cancer

Most Recent Events

  • 17 Sep 2025 Efficacy and adverse event data from a phase III trial in Actinic keratosis released by Almirall
  • 25 Aug 2025 700368972 CTP Push - KDM, HE
  • 30 Apr 2025 Almirall completes a phase III trial in Actinic keratosis in Germany, Spain, Netherlands, Poland and Italy (Topical) (NCT06135415)

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