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AX 202

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Drug Profile

AX 202

Alternative Names: AX-202; CAL-101 - Calluna Pharma

Latest Information Update: 14 Nov 2025

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At a glance

  • Originator Arxx Therapeutics
  • Developer Calluna Pharma
  • Class Anti-inflammatories; Antifibrotics; Antipsoriatics; Monoclonal antibodies
  • Mechanism of Action S100 calcium-binding protein A4 inhibitors
  • Orphan Drug Status

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

    Yes - Idiopathic pulmonary fibrosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Idiopathic pulmonary fibrosis
  • Phase I Fibrosis; Inflammation; Plaque psoriasis
  • Preclinical Systemic scleroderma
  • Research Unspecified

Most Recent Events

  • 31 Oct 2025 AX 202 receives Orphan Drug status for Idiopathic pulmonary fibrosis in USA
  • 26 Aug 2025 Pharmacodynamics data from a preclinical study in Idiopathic pulmonary fibrosis released by Calluna Pharma
  • 20 Jun 2025 Phase-II clinical trials in Idiopathic pulmonary fibrosis in USA (IV) (NCT06736990) (EUCT-2024-518339-12-00)

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