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FDA Approves Palsonify for Difficult-to-Treat Acromegaly
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A new treatment option is now available for adults battling acromegaly, a rare hormonal disorder, following the U.S. Food and Drug Administration’s (FDA) approval of Palsonify (paltusotine) tablets on September 26, 2025. The medication is indicated for patients who have not responded adequately to surgery, or for whom surgery is not a viable option.
Understanding Acromegaly and the Need for New Treatments
Acromegaly is a complex endocrine disorder characterized by the overproduction of growth hormone (GH), typically caused by a non-cancerous tumor on the pituitary gland in the brain. This excess hormone leads to the abnormal growth of bones, organs, and other tissues. Currently, surgery is the first-line treatment, but it isn’t always effective or feasible, leaving a notable unmet medical need.
palsonify Demonstrates Significant Efficacy in Clinical trials
The approval of Palsonify is based on robust data from two phase 3, randomized, double-blind, placebo-controlled studies.
In the first study, involving 111 adults with acromegaly, 56% of participants receiving Palsonify achieved biochemical control – defined as normal levels of insulin-like growth factor [IGF-1] and GH – at 24 weeks, compared to just 5% in the placebo group.
A second study,including 58 adults previously treated with and responding to other medical therapies,showed even more compelling results. At 36 weeks, 83% of patients switched to Palsonify maintained biochemical control, while only 4% of those receiving placebo did. “These results demonstrate a substantial advancement in disease control for patients who have limited treatment options,” according to a company release.
Critically important Safety Considerations for Palsonify
While offering a promising new treatment avenue, Palsonify is associated with potential risks. The medication can increase the likelihood of developing cholelithiasis (gallstones), hyperglycemia (high blood sugar), hypoglycemia (low blood sugar), bradycardia (slow heart rate), and thyroid function abnormalities. Patients may also experience steatorrhea (excessive fat in the stool) and malabsorption of dietary fats, as well as changes in vitamin B12 levels.
The most commonly reported side effects include diarrhea, abdominal pain, nausea, decreased appetite, bradycardia, hyperglycemia, and gastroenteritis (stomach inflammation).
Dosage and Administration Guidelines
The recommended starting dose of Palsonify is 40 mg taken orally once daily with water on an empty stomach. Patients should take the medication at least 6 hours after a meal – ideally after overnight fasting – and at least 1 hour before their next meal.
During the initial treatment phase, the dosage may
