MHRA Approves Icotyde Oral IL-23 Peptide for UK Psoriasis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Icotyde (icotrokinra hydrochloride), a first-in-class oral IL-23 receptor peptide inhibitor, for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 and older weighing at least 40kg. Reported on 28 October 2026, the once-daily 200mg tablet opens a substantial new oral alternative to injectable biologics in the UK dermatology category, intensifying competitive pressure across the £multi-billion global psoriasis therapeutic market.

 Icotyde selectively binds to and blocks the IL-23 receptor, interrupting the IL-23-driven inflammatory and immune responses that contribute to chronic inflammation in psoriasis. The MHRA authorisation covers patients who are candidates for systemic therapy and is supported by four Phase 3 trials involving approximately 2,500 participants, including 72 adolescents aged 12 to under 18. At week 16, all four studies demonstrated efficacy versus placebo. Julian Beach, MHRA Executive Director of Operations, positioned the authorisation as providing another treatment option for patients and confirmed ongoing MHRA safety monitoring.

Icotrokinra, originally developed by Johnson & Johnson in collaboration with Protagonist Therapeutics (JNJ-2113), is positioned as the first oral peptide IL-23 receptor inhibitor, directly challenging the established injectable IL-23 biologic franchise dominated by Johnson & Johnson’s own Tremfya (guselkumab), AbbVie (Skyrizi), Sun Pharma (Ilumya) and Eli Lilly (Omvoh/mirikizumab in IBD). The oral format also challenges IL-17 injectables Novartis (Cosentyx), UCB (Bimzelx) and Eli Lilly (Taltz), alongside oral TYK2 inhibitor Bristol Myers Squibb (Sotyktu/deucravacitinib) and legacy oral apremilast (Amgen/Otezla). The oral peptide IL-23 mechanism opens Protagonist Therapeutics’ broader oral peptide platform for extension into additional immunology indications.

The commercial signal is a transforming psoriasis therapeutic market where the first oral IL-23 receptor peptide challenges injectable biologic economics across adult and adolescent segments. UK MHRA approval opens near-term NHS access conversations. Expect Johnson & Johnson, Protagonist Therapeutics, AbbVie, Sun Pharma, Eli Lilly, Novartis, UCB, Bristol Myers Squibb and Amgen to sharpen their UK and global psoriasis positioning through 2027.

For the latest updates and in-depth insights into the world of Pharmaceuticals, including breakthrough treatments, industry trends, and regulatory news, contact Katie Ginger today!