Crinetics Pharmaceuticals Announces FDA Acceptance of NDA for Paltusotine for Acromegaly Treatment

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announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for paltusotine, an investigational once-daily oral medication for the treatment and long-term maintenance therapy of acromegaly in adults. The FDA assigned a Prescription Drug User Fee Act target action date of September 25, 2025, for the completion of its review. If approved, paltusotine will offer a new treatment option for acromegaly patients, providing a convenient alternative to currently available injectable therapies.

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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.