Crinetics Pharmaceuticals Inc.
FDA Approves Crinetics' PALSONIFY for Acromegaly Treatment
Summary
On September 25, 2025, Crinetics Pharmaceuticals, Inc. announced that the FDA approved PALSONIFY (paltusotine), the first once-daily oral treatment for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option. The approval is based on data from two pivotal Phase 3 trials that demonstrated PALSONIFY's effectiveness in biochemical control and symptom reduction in acromegaly patients. PALSONIFY is expected to be available in the U.S. in early October, with a comprehensive support program, CrinetiCARE, launched to assist patients throughout their treatment journey. A Marketing Authorization Application for PALSONIFY is under review in the European Union, with a timeline for the CHMP opinion expected in the first half of 2026.
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About Crinetics Pharmaceuticals Inc.
Crinetics Pharmaceuticals Inc. is a biopharmaceutical company dedicated to the development of novel therapeutics for patients with endocrine conditions and other rare diseases. The primary focus of Crinetics is on crafting oral therapies that target hormone receptors, offering significant potential to transform the treatment landscape for several disorders. The company's pipeline includes investigational drugs such as paltusotine and CRN04894, aimed at addressing conditions like acromegaly and congenital adrenal hyperplasia, respectively. Crinetics combines cutting-edge drug discovery with an in-depth understanding of disease biology to impact the field of endocrinology substantially. By specializing in small molecules, Crinetics Pharmaceuticals seeks to provide new treatment options that enhance patient quality of life and address significant unmet medical needs. Headquartered in San Diego, California, the enterprise collaborates with academic institutions and industry partners to position its innovations at the forefront of medical advancement. Its work holds significant potential to influence the pharmaceutical industry, contributing to the expansion of targeted therapies within niche markets where few options currently exist.
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