Paltusotine: First Approval.

Paltusotine (PALSONIFY™) is a non-hormonal, orally active selective somatostatin receptor 2 (SSTR2) agonist that controls insulin-like growth factor-1 (IGF-1) levels, which are elevated in patients with acromegaly. It is the first approved once daily, orally administered treatment available for the treatment of acromegaly. Paltusotine received its first approval in the USA in September 2025, based on results from the PATHFNDR-1 and PATHFNDR-2 phase III clinical trials in patients with acromegaly. This article summarizes the milestones in the development of paltusotine leading to this first approval for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.