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SEP 25 2025
APPROVED · 369 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 in which the body makes too much growth hormone after the growth plates have closed, causing hands, feet, and facial features to enlarge and leading to joint pain, headaches, vision problems, and complications like type 2 diabetes and sleep apnea. Palsonify is an oral medicine that mimics somatostatin, the body's own hormone that acts as a brake on growth hormone release, by binding to the SST2 receptor. Because acromegaly is driven by unchecked growth hormone, calming that receptor may lower hormone levels and ease symptoms — without a monthly injection.

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