Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Icotrokinra (Icotyde, JNJ-77242113, JNJ-2113, PN-235): what the evidence says

Name: Icotrokinra (Icotyde, JNJ-77242113, JNJ-2113, PN-235)
Published: 2026-10-27

At a glance

What it is: a 13-amino-acid peptide pill that blocks the IL-23 receptor. Discovered by Protagonist (as PN-235) and developed by Johnson & Johnson. ^{R1, R2} FDA-approved as Icotyde in Mar 2026 for moderate-to-severe plaque psoriasis in adults and in children 12 and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. ^{R3, R1, R4}

What the evidence says: Human in four phase 3 trials, far more people had clear or almost clear skin at 16 weeks than on placebo (for example 65% vs 8%), and it beat deucravacitinib, another psoriasis pill. ^{R5, R6} A phase 2b trial in ulcerative colitis was also positive. ^R7

Biggest risks: infections (avoid starting during an active infection), tuberculosis checks and no live vaccines, per the label. ^R1

Rating


Human Human evidence	Strong: four phase 3 RCTs and a phase 2b ^{R5, R8, R6, R9}
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved ^R3 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R10, R11, R12} · not named by WADA ^R13
Established human dose	Yes, label dose (see Study details)

Evidence verdict: Plaque psoriasis: Strong (multiple phase 3 RCTs; FDA-approved) · Ulcerative colitis: Limited (one phase 2b RCT) · Other uses: No human data

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: this is one of the best-studied drugs on the site for its approved use. All of the trials were funded by the manufacturer.

What is it?

Related pages: pn-943, rusfertide.

Does it work?

Human FRONTIER 1 (phase 2b, 16 weeks, n = 255): 37% to 79% reached PASI 75 across five dose groups vs 9% on placebo. ^{R9, R14}
Human ICONIC-LEAD (phase 3, n = 684, ages 12+): 65% clear or almost clear skin (IGA 0/1) vs 8% on placebo; 50% reached PASI 90 vs 4%. ^{R5, R15}
Human ICONIC-TOTAL (phase 3, n = 311, scalp, genital, hand or foot psoriasis): IGA 0/1 in 56.7% vs 5.8% on placebo. ^{R8, R16}
Human ICONIC-ADVANCE 1 and 2 (phase 3, n = 774 and 731): IGA 0/1 in 68% and 70% vs 11% and 9% on placebo, and better than deucravacitinib on all coprimary endpoints. ^{R6, R17, R18}
Human Ulcerative colitis (phase 2b, 12 weeks, n = 252): clinical response 55% to 63% vs 27% on placebo. Not an approved use. ^R7

Is it safe?

Human Label warnings: infections, tuberculosis and live vaccines. No contraindications listed. ^R1
Human Most common side effects (at least 1%): headache, nausea, cough, fungal infection and fatigue. ^R1
Human Across 2,400 people followed for up to a year, side-effect rates were similar to placebo through week 16 and stayed steady through week 52. ^R19

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved as Icotyde (NDA 220149), prescription only. ^{R3, R1}
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R10, R11, R12}
Sport: not named on WADA's 2026 Prohibited List. ^R13

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
FDA label	Adults and children 12+ (at least 40 kg)	Oral	200 mg once daily, empty stomach, 30 minutes before food	Ongoing	Approved dose	^R1
FRONTIER 1 (phase 2b)	255 adults	Oral	25 mg once daily up to 100 mg twice daily	16 weeks	PASI 75 in 37% to 79% vs 9%	PMID 38324484
ICONIC-LEAD (phase 3)	684 adults and adolescents	Oral	Once daily	16 weeks	IGA 0/1 65% vs 8%	PMID 41191940
ICONIC-ADVANCE 1 and 2 (phase 3)	774 and 731 adults	Oral	Once daily	16–24 weeks	Beat placebo and deucravacitinib	PMID 40976249
Ulcerative colitis (phase 2b)	252 adults	Oral	100, 200 or 400 mg once daily	12 weeks	Clinical response 55% to 63% vs 27%	PMID 42874103

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Icotyde prescribing information, label published Mar 17, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aee3c963-edc0-4252-8769-cdf6c7cdc21a
^R2 Protagonist Therapeutics, Protagonist Therapeutics Announces Positive Topline Results for Phase 2b FRONTIER 1 Clinical Trial of Oral IL-23 Receptor Antagonist JNJ-2113 (PN-235) in Psoriasis (press release). https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html
^R3 Drugs@FDA, Icotyde (icotrokinra), application NDA220149 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA220149
^R4 Johnson & Johnson, FDA approval of ICOTYDE (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide (press release), Mar 2026. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide
^R5 Bissonnette R, et al. N Engl J Med. 2025. PMID 41191940
^R6 Gold LS, et al. Lancet. 2025. PMID 40976249
^R7 Abreu MT, et al. N Engl J Med. 2026. PMID 42874103
^R8 Gooderham M, et al. NEJM Evid. 2025. PMID 41191932
^R9 Bissonnette R, et al. N Engl J Med. 2024. PMID 38324484
^R10 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R11 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R12 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R13 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R14 ClinicalTrials.gov NCT05223868, FRONTIER 1, phase 2 in plaque psoriasis, completed, 255 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT05223868
^R15 ClinicalTrials.gov NCT06095115, ICONIC-LEAD, phase 3, 684 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT06095115
^R16 ClinicalTrials.gov NCT06095102, ICONIC-TOTAL, phase 3 in high-impact sites, 311 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT06095102
^R17 ClinicalTrials.gov NCT06143878, ICONIC-ADVANCE 1, phase 3 vs placebo and deucravacitinib, 774 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT06143878
^R18 ClinicalTrials.gov NCT06220604, ICONIC-ADVANCE 2, phase 3 vs placebo and deucravacitinib, 731 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT06220604
^R19 Lebwohl MG, et al. Dermatol Ther (Heidelb). 2026. PMID 42663861

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Icotrokinra (Icotyde, JNJ-77242113, JNJ-2113, PN-235). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).