XERMELO

This brand name is authorized in Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

The drug XERMELO contains one active pharmaceutical ingredient (API):

1 Telotristat etiprate UNII 8G388563M7 - TELOTRISTAT ETHYL

Both the prodrug (telotristat ethyl) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2, the rate limiting steps in serotonin biosynthesis). Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome. Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome. Read about Telotristat

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XERMELO Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A16AX15		A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX15

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02481553
Country: EE	Ravimiamet	Identifier(s): 1753859, 1753860
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171224001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 403615
Country: FR	Base de données publique des médicaments	Identifier(s): 60705470
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 348419
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8459
Country: IT	Agenzia del Farmaco	Identifier(s): 045682010, 045682022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1083945, 1083946
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 148075
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100397218
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69129001, W69129002
Country: US	FDA, National Drug Code	Identifier(s): 70183-125, 70720-125