FDA & Government News

FDA Approves First Once-Daily Oral Therapy for Acromegaly

Once-daily paltusotine offers an oral alternative to monthly injections for eligible adults.

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The FDA has approved PALSONIFY™ (paltusotine), the first once-daily oral medication for adults with acromegaly who have not responded adequately to surgery or for whom surgery is not an option. Paltusotine is a nonpeptide somatostatin receptor type 2 agonist, marking a significant shift from monthly injectable treatments. The approval was supported by phase 3 trials PATHFNDR-1 and PATHFNDR-2, demonstrating its efficacy in managing IGF-1 levels and symptoms. This landmark decision advances treatment options for patients with this rare endocrine disorder.

Original Source(s)

FDA Approves First Once-Daily Oral Therapy for Acromegaly

Once-daily paltusotine offers an oral alternative to monthly injections for eligible adults.

  • by Kathryn Wighton

  • September 26, 2025

  • 2 min

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