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Source document· March 18, 2026

Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis

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Protagonist Therapeutics Announces U.S…
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  • The FDA approval of ICOTYDE demonstrates the strength of Protagonist's peptide technology platform to generate innovative therapies

    60% confidence
  • ICOTYDE is the first and only IL-23R targeted oral peptide that delivers complete skin clearance

    60% confidence
  • Approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved a PASI90 response at Week 16 in head-to-head studies

    60% confidence
  • Transition to systemic therapy is recommended if two cycles of topical medications applied for four weeks fail to bring meaningful improvement

    60% confidence
  • More than 125 million people worldwide live with plaque psoriasis

    60% confidence
  • This is the beginning of a multi-year product-driven growth cycle for Protagonist Therapeutics

    60% confidence
  • Approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved PASI90 response at Week 16 in head-to-head studies

    60% confidence
  • Nearly one-quarter of all people with plaque psoriasis have cases that are considered moderate to severe

    60% confidence
  • Transition to systemic therapy is recommended if two cycles of topical medications applied for four weeks fail to bring meaningful improvement

    60% confidence
  • The FDA approval of ICOTYDE demonstrates the strength of Protagonist's peptide technology platform to generate innovative therapies

    60% confidence
  • ICOTYDE offers a novel plaque psoriasis treatment that combines the established efficacy and safety of IL-23 pathway blockade with the convenience of a once-daily oral pill

    60% confidence
  • Psoriasis affects more than eight million Americans

    60% confidence
  • Psoriasis affects more than eight million Americans

    60% confidence
  • ICOTYDE offers a novel plaque psoriasis treatment that combines the established efficacy and safety of IL-23 pathway blockade with the convenience of a once-daily oral pill

    60% confidence
  • More than 125 million people worldwide live with plaque psoriasis

    60% confidence
  • Rates of adverse reactions for ICOTYDE treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified through Week 52

    60% confidence
  • With the pending FDA decision for rusfertide this year, and the financial resources for accelerating pipeline investment, this is the beginning of a multi-year product-driven growth cycle for Protagonist Therapeutics

    60% confidence
  • ICOTYDE is the first and only IL-23R targeted oral peptide that delivers complete skin clearance and a favorable safety profile in a once-daily pill

    60% confidence
  • Nearly one-quarter of all people with plaque psoriasis have cases that are considered moderate to severe

    60% confidence
  • Rates of adverse reactions for ICOTYDE treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified through Week 52

    60% confidence
Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis — Source | Via News | Via News