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ORKA 001

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Drug Profile

ORKA 001

Alternative Names: ORKA-001; ORKA-021; PR-035

Latest Information Update: 18 Aug 2026

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At a glance

  • Originator Paragon Therapeutics
  • Developer Oruka Therapeutics; Paragon Therapeutics
  • Class Antibodies; Antipsoriatics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Interleukin-23 subunit p19 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 II Plaque psoriasis

Most Recent Events

  • 10 Aug 2026 Oruka Therapeutics plans a phase III trial for Plaque psoriasis in the first half of 2027
  • 10 Aug 2026 Oruka plans to initiate phase II trials (Combination therapy) in 2027 (SC)
  • 14 May 2026 Oruka Therapeutics announces intention to submit BLA for Plaque psoriasis

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