5 Key Takeaways

• 1

  The FDA has approved PALSONIFY™ (paltusotine) as the first once-daily oral therapy for acromegaly.

• 2

  Paltusotine is indicated for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option.

• 3

  This medication is the first oral, nonpeptide somatostatin receptor type 2 agonist for acromegaly patients.

• 4

  The approval is based on data from two phase 3 trials, PATHFNDR-1 and PATHFNDR-2, demonstrating efficacy in managing IGF-1 levels.

• 5

  Paltusotine received Orphan Drug Designation in July 2020, providing regulatory incentives for its development.