Palsonify (paltusotine hydrochloride)
- Region
- 🇺🇸 US
- Active substance
- paltusotine hydrochloride
- Company
- Crinetics
- Status
- Approved
- FDA approval
- Thu 25 Sep 2025
- Designations
- New molecular entity
- Application
- NDA219070
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Palsonify (paltusotine) approved in the EU
Marketing authorisation to Crinetics Pharmaceuticals Europe GmbH; Orphan, Additional monitoring · source
Palsonify (paltusotine): CHMP positive opinion
Crinetics Pharmaceuticals Europe GmbH; Orphan, Additional monitoring · source
PALSONIFY: PDUFA target action date (acromegaly)
Crinetics Pharmaceuticals, Inc. (CRNX); paltusotine; NDA; status: set; "Crinetics Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update Regulatory Interactions and Commercial, Medical and Corporate Preparations On-Track for PALSONIFY™ (paltusotine) New Drug Application with September 25, 2025 PDUFA Date Continued Progress on the Global Development…"; filed 2025-08-07 · 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.