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Amlitelimab - Sanofi

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Drug Profile

Amlitelimab - Sanofi

Alternative Names: KY-1005; SAR-445229

Latest Information Update: 27 Jun 2026

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At a glance

  • Originator Kymab
  • Developer Kymab; Sanofi
  • Class Anti-inflammatories; Antiasthmatics; Antipsoriatics; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action OX40 ligand 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 III Atopic dermatitis
  • Discontinued Alopecia areata; Asthma; Coeliac disease; Graft-versus-host disease; Hidradenitis suppurativa; Systemic scleroderma

Most Recent Events

  • 21 May 2026 Sanofi terminates phase II trial in Alopecia areata (Monotherapy) in the US, Argentina, Australia, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Italy, Japan, the Netherlands, Romania, Spain, and the United Kingdom (SC) due to sponsors decision (NCT06444451)
  • 23 Apr 2026 Discontinued - Phase-II for Asthma (Adjunctive treatment) in Turkey, Poland, Mexico, South Korea, South Africa, United Kingdom, Japan, Italy, Brazil, Chile, Argentina, Hungary, Canada, USA (SC) (Sanofi pipeline, April 2026)
  • 08 Apr 2026 Sanofi completes a phase I trial (In volunteers) in USA (SC) (NCT07146750)

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