Redemplo (plozasiran sodium)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- plozasiran sodium
- Company
- Arrowhead
- Status
- Approved
- FDA approval
- Tue 18 Nov 2025
- Designations
- New molecular entity
- Application
- NDA219947
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 19 Jun 2026🇪🇺 EU approval (EC decision)
Redemplo (plozasiran) approved in the EU
Marketing authorisation to Arrowhead Pharmaceuticals Ireland Limited; Orphan, Additional monitoring · source
Thu 23 Apr 2026🇪🇺 CHMP positive opinion
Redemplo (plozasiran): CHMP positive opinion
Arrowhead Pharmaceuticals Ireland Limited; Orphan, Additional monitoring · source
Tue 18 Nov 2025🇺🇸 FDA approval
FDA approves Redemplo (plozasiran sodium), a new medicine
Arrowhead; NDA219947; New molecular entity; solution · source
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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.