Prescription medicine
Paltusotine Brand names: Palsonify
Paltusotine (Palsonify) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the paltusotine FDA label on DailyMed (effective September 16, 2025, Crinetics Pharmaceuticals, Inc.); the NDA 219070 record on Drugs@FDA; every paltusotine label on DailyMed.
Highlights of the record
FDA label of September 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Forms and strengths
- 20 mg
- 30 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 25, 2025 Palsonify, Crinetics; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 25, 2044 Palsonify tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 223 through July 30, 2026
What is paltusotine used for?
From the label: indications and usagePALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option ( 1 ).
Source: FDA drug label (PALSONIFY), Crinetics Pharmaceuticals, Inc., effective September 16, 2025 (SPL set 8a6d2ce0-a621-4ee7-983c-977cd948ff4d), via openFDA; the full label on DailyMed
Is there a generic for paltusotine (Palsonify)?
No generic paltusotine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Palsonify tablets: the compound patent runs to January 16, 2039, and the last listed entry to March 25, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2044 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the paltusotine label say about other medicines?
The paltusotine label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | May require PALSONIFY dosage increase ( 2.3 , 7.1 ) Cyclosporine: may decrease cyclosporine exposure. |
| Glucagon | warnings and precautions | Hyperglycemia and Hypoglycemia PALSONIFY may alter the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone, which may result in hypoglycemia, hyperglycemia, or diabetes mellitus. |
Source: FDA drug label (PALSONIFY), Crinetics Pharmaceuticals, Inc., effective September 16, 2025 (SPL set 8a6d2ce0-a621-4ee7-983c-977cd948ff4d), via openFDA; the full label on DailyMed
What do FAERS reports show for paltusotine?
The FDA Adverse Event Reporting System holds 223 reports that list paltusotine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 13 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Paltusotine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other