Icotrokinra clinical trials
Icotrokinra is named as an intervention in 10 current clinical trials in our USA, Germany, Spain, Poland, Canada, Taiwan, Australia, UK, Japan, South Korea, Turkey, China, Brazil, India, Italy, Czechia, France, Belgium, Portugal, Denmark, Netherlands, Sweden, Switzerland, Israel, Mexico and Austria registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Janssen Research & Development, LLC (9). The most-studied condition is Plaque Psoriasis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Icotrokinra is approved
All regulators →Of the three regulators tracked here, the first to approve Icotrokinra was the US, on 17 Mar 2026. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Icotrokinra patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Icotrokinra, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 19 Nov 2041 (US 11939361).
- Latest patent on the drug substance itself: 14 Jan 2041 (US 11845808).
- Exclusivity NCE: New chemical entity, until 17 Mar 2031.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Icotrokinra works
All drug targets →- Generalized pustular psoriasisPhase 3
- Psoriasis vulgarisPhase 3
- Psoriatic arthritisPhase 3
- Ulcerative colitisPhase 3
- Crohn diseasePhase 2/3
- PsoriasisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL6068124, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 14181, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Icotrokinra
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- EUEuropean Union: IcotydeEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Icotrokinra
10 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Icotrokinra in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Icotrokinra. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Phase 3, Multicenter, Open Label, Basket, Long-term Extension Study of Icotrokinra in Pediatric Clinical Study Participants
2026-526290-41-00 · CTIS ↗ · Immune System Diseases
|
Phase 3 | Authorised | Janssen Cilag International | Hungary, Spain, Germany + 1 more |
Icotrokinra across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Supply shortages
No entry for Icotrokinra in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- IcotydeEMA · 18 Sep 2026 · Janssen-Cilag International
Conditions studied with Icotrokinra
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Janssen Research & Development, LLC | 9 |
| Janssen Pharmaceutical K.K | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Icotrokinra trials
How many clinical trials are testing Icotrokinra?
10 current trials in our USA, Germany, Spain, Poland, Canada, Taiwan, Australia, UK, Japan, South Korea, Turkey, China, Brazil, India, Italy, Czechia, France, Belgium, Portugal, Denmark, Netherlands, Sweden, Switzerland, Israel, Mexico and Austria registers name Icotrokinra (also registered as JNJ-77242113) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Icotrokinra trials recruiting patients?
Yes. 1 of the 10 trials is recruiting: 1 with sites in USA, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Poland, 1 with sites in Canada, 1 with sites in Taiwan, 1 with sites in Australia, 1 with sites in UK, 1 with sites in Japan, 1 with sites in South Korea, 1 with sites in Turkey, 1 with sites in China, 1 with sites in Brazil, 1 with sites in India, 1 with sites in Italy, 1 with sites in Czechia, 1 with sites in France, 1 with sites in Belgium, 1 with sites in Portugal, 1 with sites in Netherlands, 1 with sites in Sweden, 1 with sites in Switzerland and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Icotrokinra clinical trials?
Janssen Research & Development, LLC (9) and Janssen Pharmaceutical K.K (1). The number in brackets is how many trials each organisation leads.
Is there a Icotrokinra shortage?
Not in the lists we track: Icotrokinra has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Icotrokinra works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Icotrokinra works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Icotrokinra (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.