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Amlitelimab - Sanofi

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Drug Profile

Amlitelimab - Sanofi

Alternative Names: KY-1005; SAR-445229

Latest Information Update: 27 May 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

  • 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)
  • 02 Apr 2026 Sanofi completes a phase I trial in Atopic dermatitis in Germany (SC, injection) (NCT06686628)

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