ACCESS Newswire·Mar 18, 2026, 8:05 AM ET

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

Protagonist Therapeutics announced FDA approval of ICOTYDE (icotrokinra) for moderate-to-severe plaque psoriasis in adults & pediatric patients 12+ years weighing at least 40 kg.
ICOTYDE is the first & only targeted oral peptide designed to block the IL-23 receptor for this indication.
Johnson & Johnson will commercialize ICOTYDE under a 2017 collaboration agreement, having assumed responsibility for development beyond Phase 1.
FDA approval triggered a $50 million milestone payment to Protagonist.
Protagonist is eligible for up to $580 million in future regulatory & sales milestones plus 6-10% tiered royalties on global net sales.
Approval was supported by four Phase 3 studies involving 2,500 patients that met all primary endpoints.
Clinical data showed approximately 70% of patients achieved clear/almost clear skin & 55% achieved PASI90 response at Week 16.
Safety profile was favorable with adverse reaction rates within 1.1% of placebo through Week 16 & no new safety signals identified through Week 52.
ICOTYDE dosing consists of one once-daily pill taken with water upon waking, 30 minutes before eating.
Additional Phase 3 studies are ongoing for psoriatic arthritis, ulcerative colitis, & Crohn's disease.
Protagonist holds an option to co-commercialize its other candidate rusfertide in the U.S. via a 50/50 profit-sharing structure.
An investor webcast & conference call were scheduled for March 18, 2026, at 8:30 am ET.