Icotyde (icotrokinra hydrochloride)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- icotrokinra hydrochloride
- Company
- Janssen Biotech
- Status
- Approved
- FDA approval
- Tue 17 Mar 2026
- Designations
- New molecular entity, Priority review
- Application
- NDA220149
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 18 Sep 2026🇪🇺 EU approval (EC decision)
Icotyde (icotrokinra hydrochloride) approved in the EU
Marketing authorisation to Janssen-Cilag International; Additional monitoring · source
Thu 23 Jul 2026🇪🇺 CHMP positive opinion
Icotyde (icotrokinra hydrochloride): CHMP positive opinion
Janssen-Cilag International; Additional monitoring · source
Tue 17 Mar 2026🇺🇸 FDA approval
FDA approves Icotyde (icotrokinra hydrochloride), a new medicine
Janssen Biotech; NDA220149; New molecular entity, Priority review; tablet · source
Same substance in other markets
- 🇪🇺 Icotyde Authorised · Janssen-Cilag International
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.