# PALSONIFY
> **NDA219070** · New Drug Application · Sponsor: CRINETICS · Approved 2025-09-25
## Drug
- **FDA Application Number:** NDA219070
- **Application type:** New Drug Application
- **Brand name:** PALSONIFY
- **Generic name:** PALTUSOTINE
- **Active ingredients:** PALTUSOTINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** CRINETICS
- **Manufacturer:** Crinetics Pharmaceuticals, Inc.
- **First approval:** 2025-09-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219070)
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