The pivotal U.S. Food and Drug Administration (FDA) approval of PALSONIFY™ (paltusotine), a novel nonpeptide SST2 agonist, was announced by Crinetics Pharmaceuticals, Inc.This medication 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.

This approval is a landmark achievement, positioning PALSONIFY as the first once-daily, oral somatostatin receptor agonist therapy available for this patient population, and ushering in a new era of care that offers a convenient alternative to prior burdensome injections.

The approval was based on compelling results from the two pivotal Phase 3 trials, PATHFNDR-1 and PATHFNDR-2, which consistently demonstrated PALSONIFY's ability to achieve rapid onset, reliable biochemical control of the key biomarker IGF-1, and sustained efficacy in both previously treated and medically untreated patients. Critically, the trials also reported significant reductions in the signs and symptoms of acromegaly—such as headaches, joint pain, and fatigue—as captured by the FDA-aligned Acromegaly Symptom Diary (ASD). Furthermore, PALSONIFY was generally well-tolerated, with long-term open-label extension phases reinforcing its durable control and consistent safety profile. Crinetics views the launch of its lead product, expected in the U.S. in early October, as a transformative milestone in its goal to become a premier endocrine-focused global pharmaceutical company. To support patient access and adherence, the company has launched CrinetiCARE®, a comprehensive program providing education, benefit verification, financial resources, and dedicated nurse educators. While securing approval in the U.S., Crinetics is also pursuing a Marketing Authorization Application for PALSONIFY in the European Union, with a timeline for a CHMP opinion anticipated in the first half of 2026, and is partnered for development in Japan; paltusotine is also currently being evaluated for carcinoid syndrome in the Phase 3 CAREFNDR trial.

Clinicians and patients should note the Important Safety Information, including warnings regarding the risk of Cholelithiasis and its complications, Hyperglycemia and Hypoglycemia, Cardiovascular Abnormalities such as bradycardia, Thyroid Function Abnormalities (hypothyroidism), Steatorrhea, and Vitamin B12 Deficiency; the most common adverse reactions reported are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.