Is Paltusotine approved by the US FDA?

Drugs@FDA lists 1 application product line for Paltusotine, including PALSONIFY (Prescription).

Is Paltusotine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Paltusotine: Palsonify.

Active substance

Paltusotine

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PALSONIFY	EQ 20MG BASE; EQ 30MG BASE	tablet · oral	CRINETICS	Prescription	25 Sep 2025

EMA European Union — centrally authorised medicines

Palsonify Crinetics Pharmaceuticals Europe GmbH · Authorised · authorised 23 Apr 2026 · ATC H01CB06

Therapeutic indication (EMA)

Palsonify is indicated for the medical treatment of adult patients with acromegaly.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.