Johnson & Johnson's main peptide story is Icotyde (icotrokinra), a once-daily pill developed with Protagonist Therapeutics that blocks the receptor for IL-23, an immune signal behind psoriasis. The FDA approved it on March 18, 2026 for moderate to severe plaque psoriasis in people aged 12 and older, and the European Commission followed on September 21, 2026. Two-year results from the ICONIC-TOTAL trial, presented on October 2, 2026, showed 70% of treated patients with clear or almost clear skin at week 112.
J&J is also testing the pill in inflammatory bowel disease, in the ICONIC-UC and ICONIC-CD trials that began in October 2025. Outside peptides, the FDA approved its antibody Imaavy (nipocalimab) on August 26, 2026 as the first treatment for warm autoimmune hemolytic anemia.
See #icotrokinra, #psoriasis, and #oral-peptide.
Johnson & Johnson said on October 9, 2026, at the Fall Clinical Dermatology Conference, that in the Phase 3 ICONIC-LEAD trial of its oral IL-23 receptor-blocking peptide Icotyde (icotrokinra) in 684 people aged 12 and older with moderate to severe plaque psoriasis, at least 70% of treated patients had clear or almost clear skin, at least 44% had completely clear skin by PASI 100, and at least 72% reached PASI 90 at week 112. Among people who reached PASI 90, stopped the drug at week 24, and later restarted it, 85% regained that response within 24 weeks. The release does not say how patients who left the study were counted, and J&J reported no new safety signals.
Johnson & Johnson reported two-year results on Friday, October 2, 2026, at the EADV Congress in Vienna from the Phase 3 ICONIC-TOTAL trial of Icotyde (icotrokinra), a once-daily oral peptide that blocks the IL-23 receptor, in 311 people aged 12 and older with psoriasis on the scalp, genitals, hands, or feet (208 on icotrokinra and 103 on placebo, who switched to the drug at week 16). Among icotrokinra-treated patients, the share with clear or almost clear skin rose from 57% at week 16 to 70% at week 112, and 60% of those with scalp psoriasis, 89% with genital psoriasis, and 63% with hand or foot psoriasis had complete clearance at those sites. Missing data after week 52 were handled with multiple imputation, and J&J reported no new safety signals.
Analytics firm GlobalData published Wednesday September 2, 2026 a myasthenia gravis (MG) market forecast projecting the seven-major-markets (7MM: United States, France, Germany, Italy, Spain, United Kingdom, Japan) MG treatment market to grow from $4.5 billion in 2024 to $13.0 billion in 2034 at an 11.1% CAGR, driven by launches and label expansions in the anti-FcRn class (argenx Vyvgart Hytrulo, Johnson & Johnson Imaavy nipocalimab), complement inhibitors (Alexion/AstraZeneca Ultomiris, Soliris), and BAFF/BLyS-targeting therapies (Cytokinetics aficamten in adjacent indications). The forecast supports the ongoing peptide-therapeutic case in autoimmune indications where synthetic peptide-vaccine and peptide-immunomodulator approaches (thymalfasin, thymosin analogs) are being evaluated as adjuncts to the biologics-first standard-of-care. Anti-FcRn represents the fastest-growing MG segment given the manageable safety profile and infrequent dosing versus the plasmapheresis and IVIG protocols that dominated the pre-Vyvgart era.
Johnson & Johnson (NYSE: JNJ) received FDA approval Wednesday August 26, 2026 for Imaavy (nipocalimab), an anti-neonatal Fc receptor (FcRn) monoclonal antibody administered as subcutaneous injection, for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 and older. Disease context: wAIHA is a rare autoimmune disease in which autoantibodies (primarily IgG) bind red blood cells at body temperature and trigger complement- and macrophage-mediated red blood cell destruction, causing fatigue, jaundice, splenomegaly, and in severe cases life-threatening anemia. Prior treatment has relied on corticosteroids, rituximab (an anti-CD20 monoclonal antibody), splenectomy, and other immunosuppressants, all with substantial side effects and variable efficacy. Nipocalimab mechanism: blocks the neonatal Fc receptor (FcRn) that normally rescues IgG antibodies from degradation; blocking FcRn accelerates IgG catabolism and reduces the pathogenic IgG autoantibody burden that drives wAIHA. The Imaavy approval extends the anti-FcRn therapeutic category that argenx pioneered with Vyvgart (efgartigimod alfa, IV and SC formulations) into a new autoimmune indication beyond the currently-approved indications of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. The FcRn category is a growing modality with multiple companies pursuing autoimmune indications; J&J's Imaavy is now approved for wAIHA and separately in myasthenia gravis, positioning as a direct competitor to argenx's Vyvgart franchise. Approval was supported by Phase 3 clinical data documenting substantial improvements in hemoglobin levels and transfusion-independence rates compared to placebo.
One-year Phase 3 data at AAD 2026 show ICOTYDE (icotrokinra) achieves 49% complete clearance at Week 52, with nearly 60% in adolescents. No new safety signals.
J&J's icotrokinra (Icotyde) approved for moderate-to-severe plaque psoriasis; in the two head-to-head trials against the pill deucravacitinib (Sotyktu), about 70% of patients achieved clear or almost clear skin by week 16.