Chemistry:Paltusotine

From HandWiki

Paltusotine, sold under the brand name Palsonify, is a medication used for the treatment of acromegaly.[1] It is a somatostatin receptor 2 agonist.[1] It is taken by mouth.[1] It was developed by Crinetics Pharmaceuticals.

The most common side effects include diarrhea, abdominal pain, nausea, decreased appetite, bradycardia, hyperglycemia, and gastroenteritis (stomach inflammation).[2]

Paltusotine was approved for medical use in the United States in September 2025.[2]

Medical uses

Paltusotine is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.[1][2]

Acromegaly is a rare endocrine disorder that causes some bones, organs, and other tissue to grow bigger.[2] The pituitary gland in the brain causes these changes by making too much growth hormone due to the presence of a non-cancerous tumor.[2]

Adverse effects

Paltusotine increases the risk of cholelithiasis (gallstones); hyperglycemia (high blood sugar); hypoglycemia (low blood sugar); bradycardia (low heart rate); thyroid function abnormalities; steatorrhea (excessive fat in the stool) and malabsorption of dietary fats; and changes in vitamin B12 levels.[2]

The most common side effects are diarrhea, abdominal pain, nausea, decreased appetite, bradycardia, hyperglycemia, and gastroenteritis (stomach inflammation).[2]

History

The safety and efficacy of paltusotine were evaluated in two randomized, double-blind, placebo-controlled, phase III studies.[2]

In study 1, 111 adults with acromegaly received paltusotine or placebo.[2] The primary endpoint was the proportion of participants achieving biochemical control (defined as insulin-like growth factor [IGF-1] and GH levels within the normal range).[2] At 24 weeks, 56% of participants who received paltusotine had achieved biochemical control compared to 5% of participants who had received placebo.[2]

In study 2, 58 adults with acromegaly who were previously treated with and responded to other medical therapy received paltusotine or placebo.[2] At 36 weeks, 83% of participants switching to paltusotine in study 2 maintained biochemical control compared to 4% of participants receiving placebo.[2]

Society and culture

Paltusotine was approved for medical use in the United States in September 2025.[3]

Names

Paltusotine is the international nonproprietary name.[4]

Paltusotine is sold under the brand name Palsonify.[1]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid <ref> tag; no text was provided for refs named Palsonify FDA label
  2. ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 "FDA approves new treatment for acromegaly, a rare endocrine disorder". 26 September 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-acromegaly-rare-endocrine-disorder.  Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ "Crinetics Announces FDA Approval of Palsonify (paltusotine) for the Treatment of Adults with Acromegaly" (Press release). Crinetics Pharmaceuticals. 25 September 2025. Retrieved 27 September 2025 – via GlobeNewswire.
  4. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020. 

Further reading

  • Clinical trial number NCT05192382 for "A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (PATHFNDR-2)" at ClinicalTrials.gov
  • Clinical trial number NCT04837040 for "A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-1)" at ClinicalTrials.gov



Retrieved from "https://handwiki.org/wiki/index.php?title=Chemistry:Paltusotine&oldid=4036294"