This data is for laboratory research purposes only. Not for human or animal consumption.
What is Icotrokinra?
Icotrokinra (brand name: ICOTYDE; also known as JNJ-2113 and JNJ-77242113) is a first-in-class oral macrocyclic peptide antagonist of the interleukin-23 receptor (IL-23R), developed by Johnson & Johnson. It received FDA approval on March 18, 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents 12 years of age and older weighing at least 40 kg — making it the first orally bioavailable targeted peptide approved for a systemic inflammatory indication.
Mechanism of Action
Icotrokinra functions by blocking the IL-23 receptor with high affinity, selectively inhibiting IL-23 signalling without affecting IL-12, which shares the IL-12Rβ1 receptor subunit. By disrupting the IL-23/IL-17 pathway — a central driver of psoriatic inflammation — icotrokinra suppresses downstream production of IL-17A, IL-17F, IL-22, and TNF-α. Its macrocyclic structure, incorporating disulfide bond cyclisation and noncanonical amino acids, confers oral bioavailability (a major breakthrough for peptide drugs) and high receptor selectivity.
Observed Clinical Results
- ICONIC-LEAD (NCT06934226): 65% achieved IGA 0/1 (clear/almost clear) and 50% achieved PASI 90 at week 16 vs placebo.
- ICONIC-ADVANCE 1 & 2: Head-to-head superiority over deucravacitinib (TYK2 inhibitor) in moderate-to-severe plaque psoriasis.
- Ulcerative colitis: Met primary clinical response endpoint in a Phase 2/3 study, suggesting broader immunological application.
- ICONIC-ASCEND: Ongoing head-to-head vs injectable biologics.
Regulatory and Compounding Status
FDA Approved (March 18, 2026) for plaque psoriasis (ICOTYDE). Oral once-daily formulation. Not eligible for compounding under 503A given its approved drug status.
Regulatory Status: WADA is expected to list icotrokinra as a prohibited substance given its immunomodulatory mechanism.