Palsonify FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 20, 2025.
FDA Approved: Yes (First approved September 25, 2025)
Brand name: Palsonify
Generic name: paltusotine
Dosage form: Tablets
Company: Crinetics Pharmaceuticals, Inc.
Treatment for: Acromegaly
Palsonify (paltusotine) 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.
- Acromegaly is a rare disease that is generally caused by a benign pituitary adenoma that secretes excess growth hormone (GH). Excess secretion of GH causes excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which then leads to progressive bone, joint, cardiovascular, metabolic, cerebrovascular, or respiratory disease. Symptoms include headache, joint aches, fatigue, sleep apnea, severe sweating, hyperhidrosis/oily skin, bone and cartilage overgrowth, abnormal growth of hands and feet, enlargement of heart, liver and other organs, and alteration of facial features.
- Acromegaly is commonly treated with monthly depot injections of peptide somatostatin receptor ligands, but these have the disadvantage of requiring many months to achieve the correct dose level, and often a return of symptoms towards the end of the monthly injection cycle.
Development timeline for Palsonify
Further information
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