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FDA Medication Tracker

← All approvals · Women's & hormonal health · 2025

Palsonify (paltusotine)

The FDA approved Palsonify (paltusotine) on September 25, 2025 to treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option.
Brand name
Palsonify
Generic name
paltusotine
FDA approval date
September 25, 2025
Approved use (FDA wording)
To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option
Company
Crinetics
Application
NDA219070
Dosage form / route
TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Women's & hormonal health

Indications and usage, from the FDA label

PALSONIFY 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 ).

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.