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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: 22 Sep 2025

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At a glance

  • Originator Paragon Therapeutics
  • Developer Oruka Therapeutics; Paragon Therapeutics
  • Class Antibodies; Antipsoriatics; 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

  • 17 Sep 2025 Pharmacokinetics, pharmacodynamics and adverse events data from a phase I trial in plaque psoriasis (In Volunteers) released by Oruka Therapeutics
  • 17 Sep 2025 Oruka Therapeutics plans a phase IIb EVERLAST-B trial for Plaque psoriasis in first half of 2026
  • 31 Jul 2025 The Health Canada approves an IND application for a phase IIa EVERLAST-A trial of ORKA 001 in Psoriasis

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