Jascayd (nerandomilast)
New indication (separate NDA)Priority review
- Region
- 🇺🇸 US
- Active substance
- nerandomilast
- Company
- Boehringer Ingelheim
- Status
- Approved
- FDA approval
- Fri 19 Dec 2025
- Designations
- New indication (separate NDA), Priority review
- Application
- NDA220449
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Wed 15 Jul 2026🇪🇺 EU approval (EC decision)
Jascayd (nerandomilast) approved in the EU
Marketing authorisation to Boehringer Ingelheim International GmbH; Additional monitoring · source
Thu 21 May 2026🇪🇺 CHMP positive opinion
Jascayd (nerandomilast): CHMP positive opinion
Boehringer Ingelheim International GmbH; Additional monitoring · source
Fri 19 Dec 2025🇺🇸 FDA approval
FDA approves Jascayd (nerandomilast): new indication (separate nda)
Boehringer Ingelheim; NDA220449; New indication (separate NDA), Priority review; tablet · source
Same substance in other markets
- 🇺🇸 Jascayd Approved · Boehringer Ingelheim
- 🇪🇺 Jascayd Authorised · Boehringer Ingelheim International GmbH
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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.