05:55 PM EDT, 09/25/2025 (MT Newswires) -- Crinetics Pharmaceuticals ( CRNX ) said late Thursday the US Food and Drug Administration approved Palsonify to treat adults with acromegaly, a rare hormonal disorder.

The approval is based on phase 3 trials, which showcased sustained efficacy and biochemical control. The drug is expected to be available in the US in early October, according to a statement.

As part of efforts to ensure broad access to Palsonify, Crinetics launched the CrinetiCARE support program to assist people with acromegaly throughout their treatment journey, the company said.

It added that a marketing authorization application for Palsonify in acromegaly is currently under review for use in the European Union, and the timeline for the Committee for Medicinal Products and Human Use opinion is H1 2026. Furthermore, Crinetics is in partnership with Sanwa Kagaku Kenkyuso to develop and commercialize the medicine in Japan.

Paltusotine is also being assessed for the treatment of carcinoid syndrome in the phase 3 trial, according to the company.