Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Shots:The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…

ByRidhi RastogiSeptember 26, 2025

NEWS

Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Shots:Following ODD grant, the EMA has accepted MAA of paltusotine for the treatment & long-term maintenance of acromegaly; NDA under the US FDA's review (PDUFA: Sep 25, 2025)Submission was supported by data from 18 trials, incl. 2 P-III trials (PATHFNDR-2 & PATHFNDR-1) assessing paltusotine vs PBO in treatment-naïve & experienced pts, respectively. These…

ByRidhi RastogiMarch 28, 2025

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Contact US

OUR INFORMATION

FOLLOW US