Paltusotine

Paltusotine
Molecular structure of paltusotine
3D representation of a paltusotine molecule
Clinical data
Trade namesPalsonify
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa625106
License data
Routes of
administration		By mouth
Drug classSomatostatin receptor agonist
ATC code
Legal status
Legal status
Identifiers
  • 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
PDB ligand
Chemical and physical data
FormulaC27H22F2N4O
Molar mass456.497 g·mol−1
3D model (JSmol)
  • C1CN(CCC1N)C2=C3C=C(C=CC3=NC=C2C4=CC(=CC(=C4)F)F)C5=CC=CC(=C5O)C#N
  • InChI=1S/C27H22F2N4O/c28-19-10-18(11-20(29)13-19)24-15-32-25-5-4-16(22-3-1-2-17(14-30)27(22)34)12-23(25)26(24)33-8-6-21(31)7-9-33/h1-5,10-13,15,21,34H,6-9,31H2
  • Key:GHILNKWBALQPDP-UHFFFAOYSA-N
  • Key:BPVXAUKYSITSMT-UHFFFAOYSA-N

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. ^ a b c d e f "Highlights of prescribing information - PALSONIFY (paltusotine) tablets, for oral use" (PDF). www.accessdata.fda.gov.
  2. ^ a b c d e f g h i j k l m "FDA approves new treatment for acromegaly, a rare endocrine disorder". U.S. Food and Drug Administration (FDA). 26 September 2025. Retrieved 27 September 2025. 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. hdl:10665/339768.

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
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