Paltusotine

Paltusotine
	Molecular structure of paltusotine
	3D representation of a paltusotine molecule
Clinical data
Trade names	Palsonify
License data	US DailyMed: Paltusotine ;
Routes of; administration	By mouth
Drug class	Somatostatin receptor agonist
ATC code	None;
Legal status
Legal status	US: ℞-only ;
Identifiers
	IUPAC name 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile;
CAS Number	2172870-89-0 ; as HCl: 2361216-83-1 ;
PubChem CID	134168328 ;
DrugBank	DB16277 ;
ChemSpider	81367268 ;
UNII	F2IBD1GMD3 ; as HCl: FZT5Z83JNS ;
KEGG	D12477 ; as HCl: D12478 ;
PDB ligand	IUD ( PDBe , RCSB PDB );
Chemical and physical data
Formula	C27H22F2N4O
Molar mass	456.497 g·mol−1
3D model (JSmol)	Interactive image ;
	SMILES C1CN(CCC1N)C2=C3C=C(C=CC3=NC=C2C4=CC(=CC(=C4)F)F)C5=CC=CC(=C5O)C#N;
	InChI 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;

Last updated October 22, 2025

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.

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

Legal status

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 2 3 4 5 6 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219070s000lbl.pdf
1 2 3 4 5 6 7 8 9 10 11 12 13 "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 .
↑ "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.
↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .

External links

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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[Palsonify_FDA_label-1] 1 2 3 4 5 6 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219070s000lbl.pdf

[FDA_Palsonify-2] 1 2 3 4 5 6 7 8 9 10 11 12 13 "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] World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .

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