Drugs / Icotrokinra
Icotrokinra
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed psoriasis 1 milestone | |||||
| Filed | US (FDA) | — | psoriasis | 2025-07-21 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ICOTYDE | — | 2026-03-17 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05703841 | Feb → Apr 2023 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05062200 | Oct 2021 → Sep 2022 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT04621630 | Nov 2020 → Sep 2021 | — | Protagonist Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 3 met primary | ||||||
| Phase 2 | NCT06049017 | Oct 2023 → Sep 2024 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT05357755 | Jun 2022 → Mar 2023 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT05364554 | Jun 2022 → Sep 2023 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT05223868 | Feb → Dec 2022 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07196722 | Oct 2025 → Sep 2028 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 39 trials · 4 met primary | ||||||
| Phase 3 | NCT07196748 | Oct 2025 → Jan 2028 expected | ulcerative colitis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06934226 | Apr → Nov 2025 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06878404 | Feb 2025 → May 2026 overdue | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06807424 | Jan 2025 → Feb 2027 expected | psoriatic arthritis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06220604 | Mar → Nov 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06295692 | Feb 2024 → Jan 2025 overdue | generalized pustular psoriasis | Janssen Pharmaceutical K.K. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06143878 | Jan → Sep 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06095102 | Oct 2023 → Jun 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06095115 | Oct 2023 → Jul 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Janssen Research & Development, LLC | Results New Johnson & Johnson ICOTYDE® (icotrokinra) long-term data demonstrate robust 2-year results in the treatment of adults and adolescents with plaque psoriasis jnj.com ↗
These data, presented at Fall Clinical Dermatology (FCD) 2026, demonstrated consistently high levels of skin clearance and patient-reported symptom improvement at Week 112, with no new safety signals identified. |
| 2026-10-09 | Janssen Research & Development, LLC | Results New Johnson & Johnson ICOTYDE® (icotrokinra) long-term data demonstrate robust 2-year results in the treatment of adults and adolescents with plaque psoriasis jnj.com ↗ |
| 2026-10-02 | Janssen Research & Development, LLC | Results Johnson & Johnson announces new ICOTYDE® (icotrokinra) data in difficult-to-treatplaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapy jnj.com ↗
Through Week 112, ICOTYDE demonstrated sustained skin clearance. |
| 2026-10-02 | Janssen Research & Development, LLC | Results Johnson & Johnson announces new ICOTYDE® (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapy jnj.com ↗ |
| 2026-03-28 | Janssen Research & Development, LLC | Results ICOTYDE™ (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new long-term 52-week data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies, which assessed the efficacy and safety of ICOTYDE™ (icotrokinra) in the treatment of patients with moderate-to-severe plaque psoriasis (PsO). |
| 2026-03-28 | Janssen Research & Development, LLC | Results ICOTYDE™ (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis jnj.com ↗
In the ICOTYDE treatment arms, rates of completely clear skin (PASI 100) increased from 41% to 49% and 33% to 48% from Week 24 to Week 52 in ADVANCE 1 and 2, respectively. |
| 2026-03-18 | Janssen Research & Development, LLC | Regulatory FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide jnj.com ↗
the U.S. Food and Drug Administration (FDA) has approved ICOTYDE™ (icotrokinra) |
| 2026-03-18 | Janssen Research & Development, LLC | Regulatory FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide jnj.com ↗ |
| 2026-02-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years jnj.com ↗
Results from the Phase 2b ANTHEM-UC study of icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, demonstrating its impact on systemic and tissue biomarkers of inflammatory burden in UC. |
| 2026-02-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years jnj.com ↗ |
| 2025-10-27 | Janssen Research & Development, LLC | Results Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis jnj.com ↗
At Week 28, icotrokinra demonstrated sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical responsea, clinical remissionb, endoscopic improvementcand histologic-endoscopic mucosal improvement (HEMI)dat Week 28 compared to placebo. |
| 2025-10-27 | Janssen Research & Development, LLC | Results Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis jnj.com ↗ |
| 2025-10-24 | Janssen Research & Development, LLC | Results Icotrokinra long-term results affirm promise of targeted oral peptide with high rates of durable skin clearance and favorable safety profile in difficult-to-treat scalp and genital psoriasis jnj.com ↗ |
| 2025-10-07 | Janssen Research & Development, LLC | Results Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill jnj.com ↗
The study met its primary endpoint, with all once-daily icotrokinra dose groups achieving clinical responseaat Week 12 and showing clinically meaningful improvements versus placebo across key secondary endpoints.[1] |
| 2025-10-07 | Janssen Research & Development, LLC | Results Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill jnj.com ↗
The study met its primary endpoint, with all once-daily icotrokinra dose groups achieving clinical response at Week 12 and showing clinically meaningful improvements versus placebo across key secondary endpoints. |
| 2025-09-17 | Janssen Research & Development, LLC | Results Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis jnj.com ↗
Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24). |
| 2025-09-17 | Janssen Research & Development, LLC | Results Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis jnj.com ↗
Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24). |
| 2025-07-21 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis jnj.com ↗ |
| 2025-07-21 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis jnj.com ↗ |
| 2025-05-09 | Janssen Research & Development, LLC | Results Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis jnj.com ↗
Icotrokinra demonstrated high rates of skin clearance in patients with scalp psoriasis as 66% achieved a scalp-specific Investigator’s Global Assessment (ss-IGA)cscore of 0/1 compared to 11% receiving placebo (P<0.001) at Week 16. |
| 2025-05-09 | Janssen Research & Development, LLC | Results Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis jnj.com ↗ |
| 2025-04-10 | Janssen Research & Development, LLC | Results Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill jnj.com ↗
Further, at Week 24, 75% of adolescents achieved IGA 0 (completely clear skin) and 63.6% achieved PASI 100.1 |
| 2025-04-10 | Janssen Research & Development, LLC | Results Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill jnj.com ↗ |
| 2025-03-10 | Janssen Research & Development, LLC | Results Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). |
| 2025-03-10 | Janssen Research & Development, LLC | Results Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients jnj.com ↗ |
| 2025-03-08 | Janssen Research & Development, LLC | Results Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis jnj.com ↗
At Week 24, nearly half of patients treated with icotrokinra achieved completely clear skin – 46% reached IGA 0 and 40% reached PASI 100. |
| 2025-03-08 | Janssen Research & Development, LLC | Results Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis jnj.com ↗
Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO |
| 2024-11-18 | Janssen Research & Development, LLC | Results Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results jnj.com ↗
Once daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. |
| 2024-11-18 | Janssen Research & Development, LLC | Results Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results jnj.com ↗
The Phase 3 study met its co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) of 0/1 response at week 16 and response rates continued to improve through week 24. |
| 2024-03-09 | Janssen Research & Development, LLC | Results New data shows JNJ-2113, the first and only investigational targeted oral peptide, maintained skin clearance in moderate-to-severe plaque psoriasis through one year jnj.com ↗
In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO. |
| 2024-03-09 | Janssen Research & Development, LLC | Results New data shows JNJ-2113, the first and only investigational targeted oral peptide, maintained skin clearance in moderate-to-severe plaque psoriasis through one year jnj.com ↗
In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO. |
| 2024-02-07 | Janssen Research & Development, LLC | Results Investigational targeted oral peptide JNJ-2113 demonstrated positive results in moderate-to-severe plaque psoriasis in Phase 2b study published in New England Journal of Medicine jnj.com ↗
The FRONTIER 1 clinical trial achieved the primary and all secondary efficacy endpoints evaluating JNJ-2113 in adults with moderate-to-severe plaque PsO. |
| 2024-02-07 | Janssen Research & Development, LLC | Results Investigational targeted oral peptide JNJ-2113 demonstrated positive results in moderate-to-severe plaque psoriasis in Phase 2b study published in New England Journal of Medicine jnj.com ↗
The FRONTIER 1 clinical trial achieved the primary and all secondary efficacy endpoints evaluating JNJ-2113 in adults with moderate-to-severe plaque psoriasis (PsO). |
| 2023-10-09 | Janssen Research & Development, LLC | Results Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress jnj.com ↗
In addition, new FRONTIER 1 data show for the first time that the targeted oral peptide JNJ-2113 induces a strong systemic pharmacodynamic response versus placebo in people living with moderate to severe plaque PsO. |
| 2023-10-09 | Janssen Research & Development, LLC | Results Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress jnj.com ↗
JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study |
| 2023-07-04 | Janssen Research & Development, LLC | Results Janssen Announces Positive Topline Results for JNJ-2113 - a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis jnj.com ↗
The trial achieved all primary and secondary efficacy endpoints. |
| 2023-07-04 | Janssen Research & Development, LLC | Results Janssen Announces Positive Topline Results for JNJ-2113—a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis jnj.com ↗
The trial achieved all primary and secondary efficacy endpoints. |
All press releases naming this drug 37 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Icotrokinra | “Icotrokinra is the first and only targeted oral peptide that selectively binds the IL-23 receptor with high affinity to precisely inhibit IL-23 signaling.” PMID 41424381 ↗ Dec 20257“Icotrokinra, a targeted oral peptide that selectively binds the interleukin-23 receptor, is under investigation for the treatment of plaque psoriasis.” PMID 41191940 ↗ Nov 2025 “Icotrokinra, a targeted oral peptide that selectively binds interleukin-23 receptors, is a new treatment being investigated for this condition.” PMID 41191932 ↗ Nov 2025 “Icotrokinra (formerly JNJ-77242113 or PN-21235) is a targeted oral peptide that selectively inhibits interleukin-23 receptor signaling.” PMID 40629250 ↗ Jul 2025 |
| Known as | JNJ-77242113 | “Icotrokinra (formerly JNJ-77242113 or PN-21235) is a targeted oral peptide that selectively inhibits interleukin-23 receptor signaling.” PMID 40629250 ↗ Jul 2025 |
| Known as | PN-21235 | “Icotrokinra (formerly JNJ-77242113 or PN-21235) is a targeted oral peptide that selectively inhibits interleukin-23 receptor signaling.” PMID 40629250 ↗ Jul 2025 |
| Known as | PN-235 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04621630 ↗ |
| Action | Inhibit | “selectively inhibits interleukin-23 receptor signaling” PMID 40629250 ↗ Jul 2025 |
| Modality | Peptide | “targeted oral peptide” PMID 40629250 ↗ Jul 2025 |
| Route | Oral | “targeted oral peptide” PMID 40629250 ↗ Jul 2025 |
| Target | IL23R | “interleukin-23 receptor signaling” PMID 40629250 ↗ Jul 2025 |