10/14/2025
FDA Approves New Treatment for Acromegaly
The U.S. Food and Drug Administration (FDA) has approved a new treatment for adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Acromegaly is a rare endocrine disorder that causes some bones, organs, and other tissues to grow bigger. Palsonify (paltusotine) is a somatostatin receptor agonist administered as an oral tablet.
The safety and efficacy of Palsonify (paltusotine) were evaluated in two randomized, double-blind, placebo-controlled, phase 3 studies. In Study 1, 111 adults with acromegaly received Palsonify or a placebo. In Study 2, 58 adults with acromegaly who were previously treated with and responded to other medical therapy received Palsonify or a placebo.
Warnings and precautions for Palsonify (paltusotine) include the increased risk of cholelithiasis, hyperglycemia, hypoglycemia, bradycardia, thyroid function abnormalities, steatorrhea, malabsorption of dietary fats, and changes in vitamin B12 levels. The most common adverse reactions to Palsonify (paltusotine) are diarrhea, abdominal pain, nausea, decreased appetite, bradycardia, hyperglycemia, and gastroenteritis.
View the FDAโs announcement here:
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-acromegaly-rare-endocrine-disorder
