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Drugs

Paltusotine: First Approval

Published in:
Author
Arnold Lee
Published in
Drugs | Issue 2/2026

Abstract

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.
Title
Paltusotine: First Approval
Author
Arnold Lee
Publication date
26-11-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 2/2026
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02260-3
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