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Amlitelimab - Kymab/Sanofi

Drug Profile

Amlitelimab - Kymab/Sanofi

Alternative Names: KY-1005; SAR-445229

Latest Information Update: 18 Dec 2025

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At a glance

  • Originator Kymab
  • Developer Kymab; Sanofi
  • Class Anti-inflammatories; Antiasthmatics; Antipsoriatics; 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
  • Phase II Alopecia areata; Asthma; Autoimmune disorders; Coeliac disease; Hidradenitis suppurativa; Systemic scleroderma
  • No development reported Graft-versus-host disease

Most Recent Events

  • 13 Nov 2025 Sanofi completes a phase-III clinical trials in Atopic dermatitis (Monotherapy, Treatment-experienced) in Taiwan, South Korea, Poland, Israel, Israel, India, Germany, Greece, France, China, Chile, Brazil, Australia, Argentina (SC) (NCT06130566)
  • 01 Nov 2025 Sanofi completes a phase III SHORE trial in Atopic dermatitis (Treatment-experienced, Monotherapy) in Argentina, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Italy, Japan, Multinational, Spain, Turkey, USA (SC) (NCT06224348)
  • 10 Oct 2025 Sanofi terminates phase II trial in Hidradenitis suppurativa (Treatment-experienced) in Australia, Canada, Chile, France, Germany, Hungary, Italy, Poland, Portugal, Spain, USA (SC) (NCT06118099)

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