Icotrokinra (Icotyde)_Dosage, benefits & legal status
Also known as Icotyde, JNJ-2113, JNJ-77242113, PN-235, icotrokinra hydrochloride
A daily tablet that does the job of the injected IL-23 antibodies, from a heavily rebuilt 13-residue peptide.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Icotrokinra (Icotyde)?
Plain language first. The technical label stays, but it never stands alone.Overview
It does what the injected psoriasis antibodies do, but swallowed. In four phase 3 trials with 2,500 people, about two-thirds had clear or almost clear skin at 16 weeks against about one in ten on placebo, and it beat the existing psoriasis pill deucravacitinib head to head. The FDA approved it on 17 March 2026.
Icotrokinra is a 13-residue cyclic peptide that blocks the IL-23 receptor, jointly discovered by Protagonist Therapeutics (code PN-235) and Johnson & Johnson; J&J developed it. Nine of its positions are unnatural or modified building blocks, chosen so the peptide survives stomach acid and gut enzymes long enough to work as a once-daily tablet with no absorption enhancer.
What it's used for
A prescription tablet for moderate to severe plaque psoriasis in adults and in children aged 12 and over who weigh at least 40 kg.
How does Icotrokinra (Icotyde) work?
What it does in the body, and where.Icotrokinra sits on the IL-23 receptor itself, where the approved antibodies grab the IL-23 cytokine instead.
- 01The psoriasis signalIL-23 keeps Th17 immune cells making IL-17 and IL-22, the signals that build thick, scaly plaques. Blocking that axis is how guselkumab, risankizumab and tildrakizumab work.
- 02Blocking the receptorIcotrokinra binds the IL-23 receptor with a dissociation constant of about 7 picomolar, so IL-23 cannot switch it on. IL-17A, IL-17F, IL-22 and beta-defensin-2 fall in blood and skin.
- 03Built to be swallowedA disulfide ring between two penicillamines and seven other unnatural building blocks protect it from gut enzymes. Blood levels stay in the low nanograms per millilitre, enough at this potency. Most of each dose leaves unchanged in the faeces.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Plaque psoriasis
FDA-approved- Human trialICONIC-LEAD, 684 people: clear or almost clear skin 65% against 8% at week 16; PASI 90 50% against 4%.
- Human trialOf week-24 responders switched at random, 84% kept PASI 90 at week 52 on the drug against 21% on placebo.
- Human trialAdolescents in ICONIC-LEAD (44 against 22): clear or almost clear skin 84% against 27%.
Against deucravacitinib
FDA-approved- Human trialICONIC-ADVANCE 1 and 2 (774 and 731 adults): superior to deucravacitinib 6 mg on clear or almost clear skin and PASI 90 at weeks 16 and 24.
- Human trialAny side effect to week 24: 57% on icotrokinra against 65% on deucravacitinib; infections 30% against 40%.
Hard-to-treat sites
FDA-approved- Human trialScalp psoriasis cleared or almost cleared in 65.9% against 10.6%, and genital psoriasis in 76.5% against 21.4%.
- No dataHands and feet: 41.7% against 26.1%, not statistically significant (p=0.144).
Ulcerative colitis
Investigational- Human trialANTHEM-UC, 252 people: clinical response at week 12 of 54.7%, 58.1% and 63.5% at 100, 200 and 400 mg against 27.0%.
- No dataRemission reached significance only at 400 mg (30.2% against 11.1%); a phase 3 has started.
It is not an 'oral IL-23 inhibitor' in the antibody sense: it blocks the IL-23 receptor and never binds IL-23 itself. The headline 'about 70% clear and 55% PASI 90' comes from the ICONIC-ADVANCE trials; ICONIC-LEAD was 65% and 50%, and figures quoted at week 24 are not the primary endpoints; those were at week 16. The '63.5%' ulcerative colitis figure is clinical response at 400 mg, not remission (30.2%), and the approved psoriasis dose is 200 mg. Clear hands and feet did not reach significance. Unlike oral semaglutide, the tablet has no absorption enhancer. It was approved on 17 March 2026; the J&J release is dated the 18th.
The published record
Papers and trials about Icotrokinra (Icotyde)
34 papers tagged human · 11 not reviews or lab · 8 clinical trial publications
16 registered trials · 8 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Icotrokinra (Icotyde)
Evidence
FDA-approved
Category
Immune support
Common vial
Varies
Half-life
About 12 hours
How much, and do you cycle it?
The range, and whether you take breaks.200 mg once daily (label), once daily, on waking, on an empty stomach. Continuous, set by the prescription FDA label
Taken every day long term. In the trial where responders were switched to placebo at week 24, most lost their response by week 52.
About 12 hoursFDA label
Median elimination half-life. Peak levels arrive at about 2 hours and steady state in about 3 days. A high-fat meal cut exposure by 43%, so it is taken fasting. Most of each dose leaves unchanged in the faeces; almost none reaches the urine.
Source: Icotyde prescribing information section 12.3
You can compare this against the whole library to see where it sits.
What does it cost?
Typical dose and cost, in plain numbers.Icotrokinra (Icotyde) is not injected
It is taken by mouth (tablet). One 200 mg tablet a day on waking, with water, on an empty stomach; wait at least 30 minutes before eating. Swallow it whole; if swallowing is hard, the label allows dispersing it in at least 120 mL of water, then rinsing with another 120 mL. No titration and no loading dose. No dose change for kidney impairment, though exposure is about 2.5 times higher below an eGFR of 60. A tablet, so the vial calculator does not apply.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Icotrokinra (Icotyde) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 31% charged residues, 46% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Active tuberculosis: the label says not to give it to people with active TB, and to consider testing for TB before starting
- A serious active infection, until it has been treated
- Live vaccines during treatment
- Children under 12 or under 40 kg, for whom it is not approved
- Pregnancy, where human data are too thin to judge and a rabbit study at 157 times the human exposure showed late pregnancy loss
Stop and get help
- Black or tarry stools, vomiting blood or severe upper stomach pain, since one person in the trials died of an upper gut bleed
- Fever, chills, a cough that will not go away or other signs of a serious infection
- Night sweats, weight loss and a cough lasting weeks, possible tuberculosis
Common effects
- Headache in 4.1% against 3.3% on placebo
- Nausea in 1.2% against 0.5%, and cough in 1.2% against 0.2%
- Fungal infections such as athlete's foot or thrush in 1.1% against none on placebo
- Fatigue in 1.0% against 0.5%
- Serious infections in 0.2% against 0.4% on placebo over 16 weeks
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Icotrokinra (Icotyde) approved?
And where the numbers on this page come from.Yes. Icotrokinra (Icotyde) is FDA approved and available on prescription in the United States. It is also approved in the European Union, Japan, and China.
- Approval statusFDA-approved
- RouteBy mouth (tablet)
- Checked13 October 2026
- Approved outside the USEuropean Union, Japan, China: EU marketing authorisation on 18 September 2026 for moderate to severe plaque psoriasis from age 12 and 40 kg. Japan (reported September 2026, also for generalised pustular and erythrodermic psoriasis) and China (reported August 2026) have approved it; J&J confirms both approvals, and the dates come from trade press. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesIcotyde prescribing information (3/2026)FDA approval letter, NDA 220149Drugs@FDA, NDA 220149FDA GSRS substance record, icotrokinra (UNII MUW8FP7HNZ)EMA, Icotyde EPARBissonnette R et al., New England Journal of Medicine 2025;393:1784-1795 (ICONIC-LEAD)Stein Gold L et al., Lancet 2025;406:1363-1374 (ICONIC-ADVANCE 1 and 2)Gooderham M et al., NEJM Evidence 2025;4(12) (ICONIC-TOTAL)Bissonnette R et al., New England Journal of Medicine 2024;390:510-521 (FRONTIER 1)J&J Medical Connect, ANTHEM-UC phase 2bJohnson & Johnson, FDA approval of Icotyde (18 Mar 2026)
What has happened recently
FDA-approved on 17 March 2026 under NDA 220149 as a new molecular entity with priority review, for moderate to severe plaque psoriasis in adults and in children aged 12 and over weighing at least 40 kg who are candidates for systemic therapy or phototherapy. The FDA asked for five years of expedited reporting of every gut-bleeding case, plus paediatric, pregnancy and lactation studies. The EU authorised it on 18 September 2026 (EMEA/H/C/006730), under additional monitoring. Japan approved it in September 2026, also for pustular and erythrodermic psoriasis, and China in August 2026; those two dates come from trade press, with J&J confirming both approvals. Protagonist licensed the IL-23 receptor programme to Janssen in 2017 and expanded the deal in 2019; J&J holds worldwide rights. No generic exists.
You can compare this against the whole library, or read how to check a seller.
What else is like Icotrokinra (Icotyde)?
Others in Immune support, side by side.If you're weighing Icotrokinra (Icotyde), it's worth reading Imunofan, Mifamurtide (Mepact), and P140 (forigerimod) in the same class.
A daily tablet that does the job of the injected IL-23 antibodies, from a heavily rebuilt 13-residue peptide.
- Dose
- 200 mg once daily (label)
- How often
- Once daily, on waking, on an empty stomach
A Russian rework of thymopentin, with one amino acid added at each end.
- Dose
- 50 mcg per dose
- How often
- Every other day, in courses
A synthetic bacterial cell-wall fragment that activates macrophages, approved in Europe for osteosarcoma but not in the US.
- Dose
- 2 mg/m2 per infusion (EU label)
- How often
- Twice weekly for 12 weeks, then weekly for 24 weeks
An experimental lupus peptide whose pivotal trial missed its endpoint in 2018.
- Dose
- 200 mcg every 4 weeks (every trial to date)
- How often
- Every 4 weeks
Guides for this compound
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Icotyde prescribing information (3/2026)(2026)A 13-amino acid peptide as the hydrochloride, 200 mg once daily fasting. Median half-life 12 hours; a high-fat meal cut AUC by 43%. Adverse reaction table pooled from four trials.
- FDA approval letter, NDA 220149(2026)Approved 17 March 2026. Requests five years of 15-day alert reports for all gut-bleeding cases, plus paediatric, pregnancy and lactation studies.
- Drugs@FDA, NDA 220149(2026)Type 1 new molecular entity, priority review; no supplements as of October 2026.
- FDA GSRS substance record, icotrokinra (UNII MUW8FP7HNZ)(2026)C90H120N20O22S2, MW 1898.17, CAS 2763602-16-8. Full chemical name giving all 13 residues and the 1-to-6 disulfide.
- EMA, Icotyde EPAR(2026)EU authorisation 18 September 2026 for plaque psoriasis from age 12 and 40 kg; additional monitoring.
- Bissonnette R et al., New England Journal of Medicine 2025;393:1784-1795 (ICONIC-LEAD)(2025)684 adults and adolescents: clear or almost clear skin 65% against 8%, PASI 90 50% against 4% at week 16.
- Stein Gold L et al., Lancet 2025;406:1363-1374 (ICONIC-ADVANCE 1 and 2)(2025)1,505 adults: superior to placebo and to deucravacitinib on clear or almost clear skin and PASI 90 at weeks 16 and 24.
- Gooderham M et al., NEJM Evidence 2025;4(12) (ICONIC-TOTAL)(2025)311 people with scalp, genital or hand and foot psoriasis: 56.7% against 5.8% clear or almost clear; hands and feet 41.7% against 26.1%, not significant (p=0.144).
- Bissonnette R et al., New England Journal of Medicine 2024;390:510-521 (FRONTIER 1)(2024)Phase 2b, 255 people: PASI 75 from 37% at 25 mg to 79% at 100 mg twice daily, against 9% on placebo.
- J&J Medical Connect, ANTHEM-UC phase 2b(2025)252 people with ulcerative colitis: clinical response 55 to 64% against 27%; remission 30.2% against 11.1% significant only at 400 mg.
- Johnson & Johnson, FDA approval of Icotyde (18 Mar 2026)(2026)Approval based on four phase 3 trials in about 2,500 people; jointly discovered with Protagonist Therapeutics.
Beyond these, 54 records are indexed. Browse the records