The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
SEP 25 2025
APPROVED · 251 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 hormonal disorder where excess growth hormone causes abnormal enlargement of hands, feet, and facial features, along with joint pain, thickened skin, and increased risk of diabetes and heart problems. Palsonify is an oral drug that mimics somatostatin, a natural hormone that puts the brakes on growth hormone production by selectively targeting receptors in the pituitary gland. By taking this biological brake in pill form, patients may maintain stable hormone levels without monthly injections, potentially improving convenience and long-term disease management.

Pivotal trial

PATHFNDR-1 Phase 3 active not recruiting NCT04837040

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

Source: ClinicalTrials.gov

Also in development