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Difamilast - Otsuka Pharmaceutical

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Drug Profile

Difamilast - Otsuka Pharmaceutical

Alternative Names: MM 36; MM-36-Medimetriks-Pharmaceuticals; Moizerto; OPA-15406

Latest Information Update: 04 Feb 2026

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At a glance

  • Originator Otsuka Pharmaceutical Development & Commercialization
  • Developer Acrotech Biopharma; Medimetriks Pharmaceuticals; Otsuka Beijing Research Institute; Otsuka Pharmaceutical Development & Commercialization
  • Class Benzamides; Nonsteroidal anti-inflammatories; Oxazoles; Skin disorder therapies; Small molecules
  • Mechanism of Action Type 4 cyclic nucleotide phosphodiesterase 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 Atopic dermatitis

Most Recent Events

  • 04 Feb 2026 Difamilast is still in phase- III trials for Atopic dermatitis (In infants) in Japan (Topical)
  • 04 Feb 2026 Difamilast is still in phase-III trials for Atopic dermatitis (In adolescents, In adults, In children, In the elderly) in the US (Topical, Ointment)
  • 24 Nov 2025 Preregistration for Atopic dermatitis in China (Topical) (Otsuka Pharmaceutical pipeline, November 2025)

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