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# FDA Approves New Drug for Acromegaly
- URL: https://www.fdaweb.com/fda-approves-new-drug-for-acromegaly/
- Published: 2025-09-26T12:00:00.000Z
- Updated: 2026-09-14T15:22:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159946

FDA has approved a Crinetics NDA for Palsonify (paltusotine) for treating adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. The rare endocrine disorder causes some bones, organs, and other tissue to grow bigger, according to an [FDA release](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-acromegaly-rare-endocrine-disorder?ref=fdaweb.com). 

Approval was based on data from two Phase 3 studies. In Study 1, 111 adults with acromegaly received Palsonify or placebo. The primary endpoint was the proportion of participants achieving biochemical control (defined as insulin-like growth factor \[IGF-1\] and growth hormone levels within the normal range). “At 24 weeks, 56% of participants who received Palsonify had achieved biochemical control compared to 5% of participants who had received placebo,” the agency says.

In Study 2, 58 adults with acromegaly who were previously treated with and responded to other medical therapy received Palsonify or placebo. “At 36 weeks, 83% of participants switching to Palsonify in Study 2 maintained biochemical control compared to 4% of participants receiving placebo,” according to the agency.

FDA says Palsonify increases the risk of gallstones; hyperglycemia; hypoglycemia (low blood sugar); bradycardia; thyroid function abnormalities; steatorrhea and malabsorption of dietary fats; and changes in vitamin B12 levels. The most common side effects seen in the trias were diarrhea, abdominal pain, nausea, decreased appetite, bradycardia, hyperglycemia, and gastroenteritis.