Paltusotine

Paltusotine
	Molecular structure of paltusotine
	3D representation of a paltusotine molecule
Clinical data
Trade names	Palsonify
AHFS/Drugs.com	Multum Consumer Information
MedlinePlus	a625106
License data	US DailyMed: Paltusotine;
Routes of; administration	By mouth
Drug class	Somatostatin receptor agonist
ATC code	H01CB06 (WHO) ;
Legal status
Legal status	US: ℞-only; EU: Rx-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;

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).⁴

Paltusotine was approved for medical use in the United States in September 2025.⁴

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.¹⁴

Acromegaly is a rare endocrine disorder that causes some bones, organs, and other tissue to grow bigger.⁴ The pituitary gland in the brain causes these changes by making too much growth hormone due to the presence of a non-cancerous tumor.⁴

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.⁴

The most common side effects are diarrhea, abdominal pain, nausea, decreased appetite, bradycardia, hyperglycemia, and gastroenteritis (stomach inflammation).⁴

History

The safety and efficacy of paltusotine were evaluated in two randomized, double-blind, placebo-controlled, phase III studies.⁴

In study 1, 111 adults with acromegaly received paltusotine or placebo.⁴ 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).⁴ At 24 weeks, 56% of participants who received paltusotine had achieved biochemical control compared to 5% of participants who had received placebo.⁴

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

Society and culture

Legal status

Paltusotine was approved for medical use in the United States in September 2025.⁵

Names

Paltusotine is the international nonproprietary name.⁶

Paltusotine is sold under the brand name Palsonify.¹

References

"Palsonify- paltusotine tablet, film coated". DailyMed. 16 September 2025. Retrieved 12 July 2026.
"Palsonify EPAR". European Medicines Agency (EMA). 27 February 2026. Retrieved 7 June 2026.
"Palsonify PI". Union Register of medicinal products. 27 April 2026. Retrieved 7 June 2026.
"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.
"International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). 2020. 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

[Palsonify_FDA_label-1] "Palsonify- paltusotine tablet, film coated". DailyMed. 16 September 2025. Retrieved 12 July 2026.

[2] "Palsonify EPAR". European Medicines Agency (EMA). 27 February 2026. Retrieved 7 June 2026.

[3] "Palsonify PI". Union Register of medicinal products. 27 April 2026. Retrieved 7 June 2026.

[FDA_Palsonify-4] "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.

[5] "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.

[6] "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). 2020. hdl:10665/339768.

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