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Evidence: HighPeptideFDA ApprovedOral IL-23 receptor antagonist peptideFDA-approved March 2026 (Icotyde)Plaque psoriasis

Icotrokinra

A daily tablet that blocks the IL-23 receptor, the pathway injected biologics target in psoriasis

Icotrokinra is a 13-amino-acid peptide from Johnson & Johnson and Protagonist Therapeutics that binds the interleukin-23 receptor and blocks a cytokine behind much of psoriasis inflammation. It is a daily tablet, not an injection. In two phase 3 trials, 68% to 70% of people reached clear or almost clear skin at week 16. FDA approved it as Icotyde on March 17, 2026.

At a Glance Read Research →
Overview

What is it?

Interleukin-23 drives much of the inflammation in plaque psoriasis, and the most effective treatments are injected antibodies against it. Icotrokinra blocks the IL-23 receptor instead, with a small engineered peptide. In human cells it inhibited IL-23 signalling at picomolar concentrations without affecting IL-12; its half-life is about 12 hours.

In the phase 2b FRONTIER-1 trial, PASI 75 responses at 16 weeks rose with dose, to 79% at the highest dose against 9% on placebo. The phase 3 ICONIC-ADVANCE trials enrolled 1,505 adults and compared it with placebo and with deucravacitinib, another oral treatment. Clear or almost clear skin at week 16 was reached by 68% and 70% on icotrokinra, against 11% and 9% on placebo, and most responses held through a year.

FDA approved it as Icotyde on March 17, 2026, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg. The dose is 200 mg on waking with water, 30 minutes before food. The label warns about infections, advises considering tuberculosis testing and avoiding live vaccines, and lists no contraindications. The EU authorised it on September 18, 2026.

Structured data

At a Glance

Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.

ClassA 13-amino-acid oral peptide that blocks the interleukin-23 receptor; FDA-approved as Icotyde in March 2026 for moderate-to-severe plaque psoriasis.
Sequence13-amino-acid peptide with a disulfide-bridged ring and non-natural residues; structure in the Icotyde label, section 11 (hydrochloride salt)
FormulaC90H120N20O22S2
Molecular weight1898.2 g/mol
Half-lifeabout 12 hours (label)
Studied dose200 mg (once daily, on waking, on an empty stomach, oral)
US statusFDA Approved
Evidence levelHigh
Last reviewed2026-09-30
Interactive

Half-Life: How Much Remains

The dataset records a half-life of about 12 hours (label) for Icotrokinra. After each half-life, half of what was in the circulation is gone, so about 3% remains after five. Real clearance varies with the person, the dose, the route and kidney or liver function; this is arithmetic on a published figure, not a dosing tool.

Time since a single dose
ElapsedTimeRemaining
1 half-life12 h50% remaining
2 half-lives24 h25% remaining
3 half-lives36 h12.5% remaining
4 half-lives2 days6.25% remaining
5 half-lives2.5 days3.125% remaining
Evidence

Published Research

These are the studies behind icotrokinra, read from their PubMed abstracts.

Human2025

ICONIC-ADVANCE 1 and 2: 1,505 adults

Clear or almost clear skin (IGA 0 or 1) at week 16 was reached by 68% and 70% on icotrokinra against 11% and 9% on placebo; PASI 90 by 55% against 4% in the first trial.

PMID: 40976249
Human2026

One-year durability

Among those randomised to icotrokinra, about 70% to 75% had clear or almost clear skin and about 50% completely clear skin during weeks 24 to 52; 85% to 90% of week-16 responders maintained their response at week 52.

PMID: 42397072
Human2026

Safety through one year

Across 1,840 participant-years, adverse events, serious adverse events, infections and discontinuations through week 16 were comparable to placebo.

PMID: 42663861
In Vitro2024

How potent and selective it is

The peptide bound the IL-23 receptor with a dissociation constant of 7.1 pM and inhibited IL-23 signalling in human cells (IC50 5.6 pM) without affecting IL-12 signalling, including in blood from people with psoriasis.

PMID: 39080319
Safety

Side Effects & Contraindications

Reported Side Effects

From the Icotyde label and the trials above.

● Infections — the label advises against starting it during an important active infection
● Adverse event rates comparable to placebo through week 16 in the pooled trials
● No contraindications listed on the label

Contraindications & Cautions

From the label; a clinician decides.

● Active, clinically important infection — treat it first
● Tuberculosis — consider testing before starting
● Live vaccines — avoid during treatment
Questions

Frequently Asked Questions

?What is icotrokinra?

A daily tablet, sold as Icotyde, containing a 13-amino-acid peptide that blocks the IL-23 receptor, a key driver of psoriasis inflammation.

?How well does it work?

In two phase 3 trials, 68% and 70% of people had clear or almost clear skin at week 16, against 11% and 9% on placebo, and most responses lasted through a year.

?How do you take it?

200 mg once a day on waking, with water, on an empty stomach, waiting at least 30 minutes before eating; the tablet can be dispersed in water.

Bibliography

References

  1. [fda-pi] Janssen Biotech. ICOTYDE (icotrokinra) tablets, US prescribing information: indication, dosage (200 mg once daily on waking), warnings (infections, tuberculosis, live vaccines), no contraindications, mechanism (IL-23R, KD 7 pM) and pharmacokinetics (half-life about 12 hours). DailyMed version effective March 17, 2026; read September 30, 2026.
  2. [pubmed] Gold LS, et al. "Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials." Lancet, 2025;406(10510):1363-1374. PMID: 40976249.
  3. [pubmed] Stein Gold L, et al. "Durability of response to icotrokinra in adults with moderate-to-severe plaque psoriasis: 1-year results from the phase III, placebo- and active comparator-controlled ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 trials." Br J Dermatol, 2026;195(4):600. PMID: 42397072.
  4. [pubmed] Lebwohl MG, et al. "Safety of Icotrokinra Through 1 Year for the Treatment of Moderate-to-Severe Plaque Psoriasis and Psoriasis Affecting High-Impact Sites: Pooled Results Across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 Phase 3 Trials." Dermatol Ther (Heidelb), 2026. PMID: 42663861.
  5. [pubmed] Fourie AM, et al. "JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans." Sci Rep, 2024;14(1):17515. PMID: 39080319.
  6. [pubmed] Bissonnette R, et al. "An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis." N Engl J Med, 2024;390(6):510-521. PMID: 38324484.
  7. [fda] FDA. Drugs@FDA (openFDA): ICOTYDE NDA 220149, approved March 17, 2026; and FDA, Novel Drug Approvals for 2026 (content current as of September 28, 2026). Read September 30, 2026.
  8. [other] European Medicines Agency. Medicines register: Icotyde, authorised September 18, 2026. Read September 30, 2026.

Sources & Citations

Every study on this page was read from its PubMed record; indications, dosing and pharmacology come from the FDA label on DailyMed. Approval details come from Drugs@FDA, FDA's Novel Drug Approvals for 2026 and EMA's register, read September 30, 2026. Grey Peptides sells nothing and links to no vendor.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.

Last reviewed: 2026-09-30