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SEP 25 2025
APPROVED · 309 DAYS AGO

Crinetics Pharmaceuticals Palsonify (paltusotine) $CRNX

for acromegaly

NDA · Standard Review · Orphan

FDA approved Palsonify as the first oral somatostatin analog for acromegaly, displacing once-monthly injectable somatostatin analogs (Sandostatin LAR, Somatuline Depot) for many patients.

About

Acromegaly is a disorder caused by excess growth hormone in adults, leading to enlarged hands, feet, and facial features, along with complications like joint pain and diabetes. Palsonify is an oral drug that selectively activates the somatostatin receptor type 2, a key biological brake on growth hormone production. By taking this brake off with a daily pill, it may control hormone levels and symptoms, offering an alternative to monthly injections.

Pivotal trial

PATHFNDR-2 Phase 3 terminated NCT05192382

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.

Source: ClinicalTrials.gov

Also in development