COMPANY RESEARCHFDA approved ICOTYDE for plaque psoriasis on 2026-03-17. Its prescribing information reports human exposure and food effects.
Profile review: 2026-11-04 · Fields retain their individual source dates. Undisclosed values are not zero; early or historical events do not establish the latest financing. Awards and acquisitions are distinguished from equity rounds.
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FDA confirms ICOTYDE's psoriasis approval. J&J's announcement describes the development collaboration with Protagonist.
Tablet-core excipients include silicon dioxide, crospovidone, magnesium stearate, and silicified microcrystalline cellulose. The label does not identify these as a dedicated permeation-enhancing system.
A high-fat meal reduced AUC by 43% and Cmax by 59%; the label requires fasting administration. A separate Phase 2b UC publication does not establish approval for that indication.
2026-09-21: ICOTYDE receives EU authorization for eligible patients with plaque psoriasis
2026-10-14: Icotrokinra Phase 2 ulcerative colitis publication details responses and testing limits
| Program / service | Target / indication | Representative stage | Evidence & scope |
|---|---|---|---|
| icotrokinra / JNJ-2113 | IL-23R · Plaque psoriasis | Approved | Human PK / efficacy data disclosed |
| icotrokinra（UC） | IL-23R · Ulcerative colitis | II期证据 | 252-patient Phase 2b study |
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Johnson & Johnson reported that 58% of patients receiving icotrokinra 200 mg achieved ACR20 at Week 16 in ICONIC-PsA 1, versus 41% with placebo. The oral IL-23 receptor peptide also showed skin responses. The company reported no new safety signals through Week 24; active psoriatic arthritis remains an investigational indication.
Johnson & Johnson reported that ICONIC-ASCEND met its Week 16 co-primary endpoints: PASI 90 responses were 55.2% with icotrokinra versus 3.6% with placebo, and IGA 0/1 responses were 70.4% versus 9.5%. At Week 28, the oral peptide met noninferiority criteria versus ustekinumab across multiplicity-controlled key secondary skin-clearance endpoints.
Triastek and its Shanghai subsidiary entered a collaboration and license agreement with Janssen Pharmaceutica NV to develop oral medicines using 3D printing and delivery technologies for peptides and other modalities. JJDC will also make an equity investment. Financial terms and named collaboration candidates were undisclosed, and the agreement does not establish clinical performance for T25.
Johnson & Johnson reported Week 112 results from ICONIC-LEAD in adults and adolescents with moderate-to-severe plaque psoriasis. The company said skin clearance and patient-reported improvements remained sustained, with no new safety signals identified. The update adds longer-term evidence for an oral IL-23 receptor peptide, although company-reported follow-up does not eliminate ongoing safety monitoring needs.
Johnson & Johnson announced European Commission authorization of ICOTYDE on September 21; EMA records the authorization date as September 18. Eligible patients include adults and adolescents aged at least 12 years weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. This regional authorization does not approve other inflammatory indications.
FDA approved icotrokinra, marketed as ICOTYDE, on March 17; Johnson & Johnson announced the decision the following day. The once-daily oral IL-23 receptor antagonist is indicated for eligible adults and patients aged 12 or older weighing at least 40 kg with moderate-to-severe plaque psoriasis. The approval does not extend to ulcerative colitis or other investigational indications.
Entera reported $265.9 million in cash and cash equivalents at September 30, plus $6.5 million in restricted cash. Its November 6 update targets first site activation for an approximately 900-patient EB613 osteoporosis Phase 3 trial in late 2026. EB613 is an oral PTH(1-34) program, included here as an adjacent oral-peptide delivery development, not a cyclic-peptide candidate.
Ahead of the AHA meeting, an original report reviewed enlicitide analyses across PREVENT cardiovascular risk groups and an open-label extension. LDL cholesterol reductions were broadly consistent across risk categories and persisted through Week 104. The extension selected participants who had tolerated and adhered to treatment and lacked a control group, limiting generalization of its long-term findings.
Aurinia reported LUPKYNIS net product sales of $232.4 million for the nine months ended September 30, 2026, up 18%, including $79.4 million in the third quarter, up 12%. Total company revenue also includes licensing, collaboration, and royalty income. These are commercialization results for an approved oral cyclic peptide, rather than a new indication approval or clinical endpoint readout.
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