Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis — 12 and older, at least 40 kg

Dek: The FDA labelled a once-daily 200 mg oral IL-23 receptor peptide for moderate-to-severe plaque psoriasis in people 12 and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. Europe has a CHMP yes, not an EC licence. Health Canada is under review — that is not a no. China’s NMPA date is company until nmpa.gov.cn. Authorized is not funded.

Access Level: FDA Approved
Canada zoom: Health Canada under review — not a no. SAP unknown. Provinces N/A until NOC.
Country or International: International (roster zoom: United States, Canada, European Union, United Kingdom, Japan, China, Australia. Switzerland: authorisation not found. Canada is a zoom, not the frame.)
Reader pillar: You or someone you love has moderate-to-severe plaque psoriasis and needs a real path — a labelled once-daily tablet where a regulator has authorised it, a Canadian under-review conversation, or a wait for an EU Commission decision — not a headline.

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Icotyde (icotrokinra; pronounced ai-koh-tide) is a 13-amino-acid peptide that binds the interleukin-23 receptor and blocks IL-23 from docking there. It is not an injectable IL-23 antibody. It is not a TYK2 inhibitor. The labelled US dose is one 200 mg tablet once a day.

The FDA labelled it on 17 March 2026 for moderate-to-severe plaque psoriasis in adults and children 12 years and older who weigh at least 40 kg (88 lb) and who are candidates for systemic therapy or phototherapy.

Europe’s medicines committee said yes on 23 July 2026. That is a recommendation, not a European Commission licence. Health Canada accepted a new-drug submission in December 2025. As of the SUR list dated 31 July 2026, icotrokinra is under review. That is not a no.

China’s NMPA approval is a Johnson & Johnson / Xi’an Janssen company announcement dated 27 August 2026 (艾特雅 / 盐酸伊可白滞素片). The nmpa.gov.cn decision page was not retrieved here.

This is not a cure. It is not labelled for guttate, erythrodermic, or pustular psoriasis on the USPI. It is not labelled for psoriatic arthritis as a standalone indication. Children under 12, or anyone under 40 kg, are not established.

Where this is taking place

Pivotal 16-week readouts are done. The four US-label trials remain ACTIVE_NOT_RECRUITING on ClinicalTrials.gov because long-term follow-up runs into 2027. That is not a new first-script enrolment slot. Access in the United States is a commercial prescription.

ICONIC-LEAD / Trial PSO-3 (NCT06095115) — Phase 3, placebo-controlled, ages 12+, actual n=684 (618 adults, 66 adolescents ≥40 kg). Status ACTIVE_NOT_RECRUITING (CT.gov verified Aug 2026). Primary completion 29 Jul 2024. Estimated completion 6 Apr 2027. Sponsor: Janssen Research & Development, LLC. 170 locations / 16 countries. Canadian sites on CT.gov (no PI named): Dermatology Research Institute, Calgary AB T2J 7E1; Rejuvenation Dermatology, Edmonton AB T5J 3S9; Dr. Chih ho Hong Medical, Surrey BC V3R 6A7; Mediprobe Research, London ON N5X 2P1; Dr Wei Jing Loo Medicine Professional Corporation, London ON N6H 5L5; Ryan Clinical Research, Newmarket ON L3Y 5G8; Canadian Dermatology Center, Toronto ON M3B 0A7; Toronto Research Centre, Toronto ON M3H 5Y8; FACET Dermatology, Toronto ON M4C 1L1; XLR8 Medical Research, Windsor ON N8T 1E6; Innovaderm Research, Montreal QC H2X 2V1.

ICONIC-ADVANCE 1 / Trial PSO-1 (NCT06143878) — Phase 3 vs placebo and deucravacitinib, ages 18+, actual n=774. Status ACTIVE_NOT_RECRUITING (verified Jul 2026). Primary completion 17 Sep 2024. 164 locations / 13 countries. Canadian sites: Enverus Medical, Surrey BC V3V 0C6; Karma Clinical Trials, St. John’s NL A1A 4Y3; CCA Medical Research, Ajax ON L1S 7K8; SimcoDerm, Barrie ON L4M 7G1; Dermatrials Research, Hamilton ON L8N 1Y2; York Dermatology Clinic and Research Centre, Richmond Hill ON L4B 1L1; Alliance Clinical Trials, Waterloo ON N2J 1C4; XLR8 Medical Research, Windsor ON N8T 1E6.

ICONIC-ADVANCE 2 / Trial PSO-2 (NCT06220604) — Replicate Phase 3 vs placebo and deucravacitinib, ages 18+, actual n=731. Status ACTIVE_NOT_RECRUITING (verified Aug 2026). Primary completion 15 Nov 2024. 128 locations / 11 countries. Canadian sites: Dr. Chih ho Hong Medical, Surrey BC; Wiseman Dermatology Research, Winnipeg MB R3M 3Z4; Lovegrove Dermatology, London ON N6A 5R9; Lynderm Research, Markham ON L3P 1X2; DermEdge Research, Mississauga ON L4Y 4C5; Skin Centre for Dermatology, Peterborough ON K9J 5K2; North York Research, Toronto ON M2N 3A6; Toronto Research Centre, Toronto ON M3H 5Y8; XLR8 Medical Research, Windsor ON; Innovaderm Research, Montreal QC; Centre De Recherche Dermatologique Du Quebec Metropolitain, Québec QC G1V 4X7.

ICONIC-TOTAL / Trial PSO-4 (NCT06095102) — Phase 3, scalp / genital / hands-and-feet, ages 12+, actual n=311 (305 adults, 6 adolescents). Status ACTIVE_NOT_RECRUITING. Primary completion 19 Jun 2024. Canadian sites: Alberta DermaSurgery Centre, Edmonton AB T6G 1C3; Lynderm Research, Markham ON; Skin Centre for Dermatology, Peterborough ON; York Dermatology, Richmond Hill ON; Innovaderm, Montreal QC; Centre Dermatologique, Québec QC G1V 4X7; Skinsense Medical Research, Saskatoon SK S7K 2C1.

These Canadian addresses are historical trial sites, not a walk-in clinic directory, and not a commercial DIN.

ICONIC-ASCEND (NCT06934226) vs ustekinumab, and the psoriatic-arthritis / ulcerative-colitis / Crohn’s ICONIC trials, are not labelled uses. They are not this Access Level.

Commercial supply (labelled): United States. European Union: wait for the Commission. Canada: not marketed. China: company NMPA. Japan: 部会了承 is not a retrieved 承認.

Approval matrix

The US line includes phototherapy candidates; the CHMP full indication does not. Japanese pustular/erythrodermic wording from trade press is not the US plaque label. Use the label of the country that will prescribe.

Access by country

• United States: Dermatologist. FDA-labelled 17 Mar 2026 for people 12+ and ≥40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 200 mg once daily upon waking, empty stomach, with water; wait at least 30 minutes before food. Swallow whole, or disperse in water if swallowing is hard. The USPI does not require a REMS. Prior authorization still applies. Janssen / ICOTYDE (USPI / Medication Guide): 1-800-526-7736 or www.ICOTYDE.com. Adverse events: the same Janssen number or FDA MedWatch 1-800-FDA-1088. Pregnancy safety study: 1-800-526-7736 or www.ICOTYDE.com. No copay dollars here. J&J’s “ICOTYDE withMe” support program is company, not a printed USPI dollar figure. A Canadian or EU script is not a US fill.

• Canada (zoom): No NOC. SUR under review (accepted Dec 2025; list current 31 Jul 2026). Janssen Inc. That is not a no. A specialist can ask Health Canada SAP for a non-marketed drug when conventional therapy has failed, is unsuitable, or is unavailable. Manufacturer must agree to supply. SAP unknown — not available and not refused. ICONIC Canadian sites above are historical; the trials are not recruiting. Provincial / territorial / NIHB / RAMQ listing is N/A until there is a NOC. CDA-AMC card not retrieved. Do not mail-order a US bottle.

• European Union: CHMP said yes 23 Jul 2026. Wait for the European Commission. Until that decision posts on the EPAR page, there is no EU marketing authorisation to fill. The CHMP line is systemic therapy, not “or phototherapy.” After an MA, national reimbursement will lag. CHMP is not a pharmacy fill.

• United Kingdom: NICE GID-TA11780 is in progress, not a yes. MHRA PIP is not an MA. Ask the dermatology clinic; do not DIY-import. NHS routine funding is not assumed.

• Japan: In-country path only after MHLW 製造販売承認 — not listed on the August 2026 PMDA new-drug table. 部会了承 is a committee step. NHI / first fill unknown. Japanese trade-press indication wording is not the US plaque-only label.

• China: In-country commercial per Johnson & Johnson for plaque psoriasis in adults and people 12+ ≥40 kg. nmpa.gov.cn was not retrieved. NRDL not found. Not a Canadian travel path.

• Australia: TGA evaluation listed Jan 2026. ARTG not retrieved. PBS status unknown. Specialist + local special-access / trial if those programs apply.

• Switzerland: Authorisation not found on documents checked. Unknown. Specialist + local special-access / trial if those programs apply.

If your regulator has not authorised it: do not import on your own. Travelling to the United States for a labelled script is a plan with both specialists, not a mail-order workaround.

Who is eligible (from the labels — they are not the same)

United States (USPI):

• Age 12 years or older.
• Weight at least 40 kg.
• Moderate-to-severe plaque psoriasis.
• Candidate for systemic therapy or phototherapy.
• Trial-style disease in PSO-1/2/3 (label §14; this is how the studies were built, not a second indication sentence): IGA ≥3, PASI ≥12, BSA ≥10% (PSO-4 allowed BSA ≥1% with special-site disease after at least one topical failure).
• Dose: 200 mg orally once daily until the prescriber stops it.
• Under 12, or under 40 kg: not established.
• Nonplaque psoriasis (guttate, erythrodermic, pustular): not the labelled indication.

CHMP opinion (not an EC SmPC):

• Adults, and adolescents 12+ and ≥40 kg.
• Moderate to severe plaque psoriasis.
• Candidates for systemic therapy (phototherapy not in that sentence).
• Start under a physician experienced in plaque psoriasis.
• Age/weight matches the US line. The phototherapy clause does not.

China (company NMPA until nmpa.gov.cn):

• Adults and children 12+ ≥40 kg, candidates for systemic therapy or phototherapy on the company note. Treat as company until the regulator page is in hand.

Not labelled on the USPI:

• Children under 12 or anyone under 40 kg.
• Guttate, erythrodermic, or pustular psoriasis.
• Psoriatic arthritis as a standalone indication (some trial patients had a PsA history; that is not a PsA label).
• Ulcerative colitis, Crohn’s disease, or ICONIC-ASCEND vs ustekinumab.

What the pivotal studies showed (use the USPI)

These numbers are from USPI section 14, not from a press release.

Trial PSO-1 (ICONIC-ADVANCE 1, NCT06143878) — adults, Week 16:

• IGA 0/1: Icotyde 68% (213/311) vs placebo 11% vs deucravacitinib 50%.
• PASI 90: 55% vs 4% vs 30%.
• PASI 100: 31% vs 1% vs 11%.
• Week 24 vs deucravacitinib: IGA 0/1 74% vs 52%; PASI 90 66% vs 41%.

Trial PSO-2 (ICONIC-ADVANCE 2, NCT06220604) — adults, Week 16:

• IGA 0/1: 71% (227/320) vs placebo 9% vs deucravacitinib 55%.
• PASI 90: 58% vs 1% vs 34%.
• PASI 100: 32% vs 1% vs 14%.

Trial PSO-3 (ICONIC-LEAD, NCT06095115) — adults and adolescents, Week 16:

• IGA 0/1: 65% (295/456) vs placebo 8%.
• PASI 90: 50% vs 4%.
• PASI 100: 27% vs <1%.
• Adolescents (n=44 vs 22): IGA 0/1 84% vs 27%; PASI 90 70% vs 14%.

Maintenance (LEAD adults re-randomised at Week 24):

• PASI 90 at Week 52: 84% (108/128) if they stayed on Icotyde vs 21% (27/129) if withdrawn. Median time to loss of PASI 90 after withdrawal: about 10 weeks.
• IGA 0/1 at Week 52: 82% vs 23%. Same ~10-week median loss after withdrawal.

Trial PSO-4 (ICONIC-TOTAL, NCT06095102) — special sites, Week 16:

• Overall IGA 0/1: 57% vs 6%.
• Scalp ss-IGA 0/1 (baseline ≥3): 66% vs 11%.
• Genital sPGA-G 0/1 (baseline ≥3): 77% vs 21%.

This is skin clearance at 16 weeks, with a withdrawal experiment after that. It is not a proven survival outcome. It is not a cure. Journals (NEJM, Lancet, NEJM Evidence) exist; a US clinic should still use the USPI tables.

How it is taken (US label)

• 200 mg (one tablet) once daily.
• Upon waking, empty stomach, with water.
• Wait at least 30 minutes before eating. A high-fat meal cut exposure (AUC down 43%, Cmax down 59%) — that is why the empty-stomach rule is on the label.
• Swallow whole. Do not crush, split, or chew.
• If swallowing is hard: put one tablet in a cup with at least 120 mL (4 oz) water; wait a few minutes (it may look yellow, milky, or cloudy; small pieces are safe to swallow); swirl; drink; add at least 120 mL more and drink that too. Finish within 15 minutes.
• Missed dose: take it when you remember; go back to the usual time the next day. The USPI does not say to take two tablets for a missed dose.
• Store 20–25 °C in the original bottle with the desiccant. Child-resistant cap. Do not throw the desiccant away.

Before starting (USPI): consider TB evaluation based on clinical judgment; finish age-appropriate vaccines; no live vaccines while on Icotyde.

eGFR <60 mL/min: monitor for adverse reactions (exposure rises in moderate and severe renal impairment).

Safety (USPI)

Contraindications: none.

Infections. Medicines that interact with the immune system may increase infection risk. In the 16-week placebo-controlled pool, serious infections were 0.2% on Icotyde vs 0.4% on placebo. Do not start during a clinically important active infection. Stop if one develops and is not responding. Tell the clinician about chronic or recurrent infections.

Tuberculosis. Consider evaluating before start. Consider treating latent/prior TB if an adequate course cannot be confirmed. Watch during and after treatment. Do not give in active TB. Call for unexplained fever, cough, or trouble breathing.

Vaccines. Avoid live vaccines during treatment. Complete immunizations first. No data on response to live or inactive vaccines.

Most common adverse reactions (≥1% and more than placebo, Weeks 0–16, n=1296 vs 568):

• Headache 4.1% vs 3.3%
• Nausea 1.2% vs 0.5%
• Cough 1.2% vs 0.2%
• Fungal infection 1.1% vs 0 (tinea, candida, and similar events in the footnote)
• Fatigue 1.0% vs 0.5%

Less than 1% and more than placebo: gastritis, abdominal discomfort, and one fatal upper-gastrointestinal bleed in a person with underlying risk factors. A relationship to Icotyde is not established.

Pediatric 12+ AEs were consistent with the overall pool (72 adolescents treated; 45 for at least a year).

Pregnancy. Human data insufficient. Rabbit study: maternal weight loss, late pregnancy loss, fused ribs at 157× the human dose. Rat studies did not show that at high multiples. Pregnancy safety study: 1-800-526-7736 or www.ICOTYDE.com.

Lactation. Present in nursing-rat pup plasma; human milk unknown.

Immunogenicity. Anti-drug antibodies in 9.6% through Week 52; no neutralizing antibodies detected; no identified effect on how the drug worked over 52 weeks.

CHMP’s public line names fungal infections as the most common side effects. That is compatible with the US table; it is not a full EU SmPC.

Research team (Who)

Names below are as they appear on primary sources.

• Janssen Biotech, Inc., Horsham, PA — FDA applicant / DailyMed packager / USPI “Manufactured for.”
• Janssen Research & Development, LLC — NCT sponsor and study director (unnamed “Clinical Trial” official on LEAD, ADVANCE 1, ADVANCE 2, TOTAL).
• Janssen Inc. — Health Canada SUR applicant.
• Janssen-Cilag International N.V. — EMA CHMP applicant.
• Janssen-Cilag Limited, High Wycombe — MHRA PIP applicant.
• Janssen-Cilag Pty Ltd — TGA evaluation sponsor card.
• Johnson & Johnson / 西安杨森制药有限公司 — China company NMPA announcement (艾特雅).
• Protagonist Therapeutics — co-origin under the licence and collaboration agreement named on the J&J US and China company pages. J&J holds exclusive rights from Phase 2 onward on those pages.
• J&J US approval release quotes Linda Stein Gold, M.D. (Henry Ford Health) as a paid consultant. That is company, not the NCT official.

No Canadian site PI is named on CT.gov. The Canadian facility list is historical, not a clinic directory.

How to talk to a doctor

Bring the NCT numbers and the regulator that applies:

1. “I have moderate-to-severe plaque psoriasis. I am 12 or older and at least 40 kg. The FDA labelled icotrokinra (Icotyde) on 17 March 2026 as a once-daily 200 mg tablet on an empty stomach, 30 minutes before food, for people who are candidates for systemic therapy or phototherapy. Is that a fit, or are we still on topicals / phototherapy / another systemic?”
2. Infections, TB screening, and live vaccines — “Do I need a TB test first? Which vaccines must be done before I start?”
3. “If I cannot swallow tablets, the USPI allows dispersing one tablet in at least 120 mL water.”
4. Kidney function: eGFR under 60 — “The label says monitor.”
5. Pregnancy: “There is a pregnancy safety study at 1-800-526-7736. Human data are insufficient.”
6. If Canada: “The NDS is under review as of 31 July 2026. Is SAP appropriate, or do we wait for a NOC? The ICONIC sites in Canada are not recruiting.”
7. If EU: “CHMP was positive 23 July 2026. Has the Commission issued the licence, or are we waiting? The CHMP sentence is systemic therapy, not phototherapy.”
8. If under 12 or under 40 kg, or if the psoriasis is guttate / pustular / erythrodermic: “That is not on the US label.”
9. If psoriatic arthritis, Crohn’s, or ulcerative colitis is the main problem: “Those ICONIC trials are not this labelled use.”

Canada zoom: under review / SAP unknown

Health Canada is under review. No NOC. SAP for a non-marketed drug is unknown — not a listing, not a refusal. Provincial listing is N/A until there is a NOC. US: labelled Rx. EU: wait for the Commission. China: company NMPA until nmpa.gov.cn. Japan: 了承 is not a retrieved 承認. Pivotals are not recruiting. Do not mail-order.

Bottom line

Icotyde (icotrokinra) is a once-daily oral IL-23 receptor peptide labelled in the United States on 17 March 2026 for moderate-to-severe plaque psoriasis in people 12 and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. Take it on waking, empty stomach, wait 30 minutes before food. Europe: CHMP yes, Commission not yet. Canada: under review, not refused. China: company NMPA 27 Aug 2026 until nmpa.gov.cn. Japan: committee 了承 is not a PMDA-list 承認. Authorized is not funded. Canada is a zoom.

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Primary sources

1. DailyMed ICOTYDE (icotrokinra) USPI / Medication Guide, setid aee3c963-edc0-4252-8769-cdf6c7cdc21a, NDA 220149, marketing start 17 Mar 2026 — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aee3c963-edc0-4252-8769-cdf6c7cdc21a
2. FDA Novel Drug Approvals 2026 (Icotyde / icotrokinra, 3/17/2026) — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
3. Drugs@FDA NDA 220149 — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220149
4. USPI PDF — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220149Orig1s000lbl.pdf
5. FDA approval letter, NDA 220149 — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220149Orig1s000ltr.pdf
6. J&J US approval release, 18 Mar 2026 (company) — https://www.multivu.com/johnson-johnson/9378651-en-icotyde-icotrokinra-fda-approval-first-line-systemic-treatment-plaque-psoriasis
7. J&J labels host USPI — https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf
8. EMA EPAR overview, Icotyde, EMEA/H/C/006730, CHMP 23 Jul 2026, EC pending — https://www.ema.europa.eu/en/medicines/human/EPAR/icotyde
9. EMA news, 24 Jul 2026 (CHMP intermediary; send to Commission) — https://www.ema.europa.eu/en/news/first-oral-medicine-targeting-interleukin-23-receptor-recommended-plaque-psoriasis
10. CHMP summary of positive opinion, 23 Jul 2026, EMADOC-1829012207-57557 — https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-icotyde_en.pdf
11. Health Canada SUR, current 2026-07-31 (Icotrokinra, accepted 2025-12, Janssen Inc) — https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html
12. Health Canada SUR completed NDS table (no Icotrokinra row) — https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-completed.html
13. Xi’an Janssen / J&J China, 27 Aug 2026 (company NMPA; 艾特雅) — https://www.xian-janssen.com.cn/news/6550
14. PMDA 承認品目一覧（新医薬品：2026年8月）— イコタイド not listed — https://www.pmda.go.jp/files/000281577.pdf
15. PMDA 2026年度承認品目一覧 index — https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0040.html
16. NICE GID-TA11780 / ID6579 — https://www.nice.org.uk/guidance/indevelopment/gid-ta11780
17. MHRA PIP MHRA-101112-PIP01-23-M02 (invented name not yet available) — https://cms.mhra.gov.uk/pip/mhra-101112-pip01-23-m02-update
18. ICONIC-LEAD NCT06095115 — https://clinicaltrials.gov/study/NCT06095115
19. ICONIC-ADVANCE 1 NCT06143878 — https://clinicaltrials.gov/study/NCT06143878
20. ICONIC-ADVANCE 2 NCT06220604 — https://clinicaltrials.gov/study/NCT06220604
21. ICONIC-TOTAL NCT06095102 — https://clinicaltrials.gov/study/NCT06095102
22. Bissonnette R et al. N Engl J Med. 2025;393:1784-1795. DOI 10.1056/NEJMoa2504187 — https://www.nejm.org/doi/full/10.1056/NEJMoa2504187
23. Stein Gold L et al. Lancet. 2025;406:1363-1374. DOI 10.1016/S0140-6736(25)01576-4
24. Gooderham M et al. NEJM Evid. 2025;4(12). DOI 10.1056/EVIDoa2500155