Is Telotristat etiprate approved by the US FDA?

Drugs@FDA lists 1 application product line for Telotristat etiprate, including XERMELO (Prescription).

Is Telotristat etiprate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Telotristat etiprate: Xermelo.

Are there safety signals or safety updates for Telotristat etiprate?

US FDA: 1 entry (latest 2022-09-26).

Active substance

Telotristat etiprate

US FDA 1
EMA 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
XERMELO	EQ 250MG BASE	tablet · oral	TERSERA	Prescription	28 Feb 2017

EMA European Union — centrally authorised medicines

Xermelo SERB SAS · Authorised · authorised 17 Sep 2017 · ATC A16A

Therapeutic indication (EMA)

Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

Safety signals and safety-related labeling changes

US FDA 26 Sep 2022 XERMELO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for telotristat etiprate →

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.