Paltusotine FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 20, 2025.
FDA Approved: No
Generic name: paltusotine
Company: Crinetics Pharmaceuticals, Inc.
Treatment for: Acromegaly
Paltusotine is an oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in development for the treatment and long-term maintenance therapy of acromegaly in adults.
- 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.
- Paltusotine is an oral SST2 nonpeptide agonist designed for once daily administration.
- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. The NDA submission was supported by data from the PATHFNDR-1 (NCT04837040) and PATHFNDR-2 (NCT05192382) Phase 3 clinical trials, which evaluated the safety and efficacy of paltusotine in previously treated and medically untreated adults, respectively. The FDA has set a Prescription Drug User Fee target action date of September 25, 2025.
- Paltusotine is also in clinical development for the treatment of carcinoid syndrome associated with neuroendocrine tumors.
Development timeline for paltusotine
Further information
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