25 September 2025 - Approval based on data from two pivotal Phase 3 trials where Palsonify was well tolerated and resulted in rapid, durable, and consistent biochemical control and reduced symptom burden.

Crinetics Pharmaceuticals today announced that the US FDA approved Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

Read Crinetics Pharmaceuticals press release