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Molecule

Telotristat ethyl

Tryptophan Hydroxylase Inhibitor
Available on requestOrphanRare diseases and enzyme replacement
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Telotristat ethyl is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. MedsAcross supplies Telotristat ethyl for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Tryptophan Hydroxylase Inhibitor, Tryptophan Hydroxylase Inhibitors
ATC classification
A16A Metabolic disease treatments, including enzyme replacement, subgroup A16A · Metabolic disease treatments, including enzyme replacement
US FDA first approval
Not recorded
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 8G388563M7RxCUI 1872441CAS 1033805-22-9DrugBank DB12095Q27270371

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

Source: US FDA prescribing information

How it works

Telotristat, the active metabolite of telotristat ethyl, is an inhibitor of tryptophan hydroxylase, which mediates the rate limiting step in serotonin biosynthesis. The in vitro inhibitory potency of telotristat towards tryptophan hydroxylase is 29 times higher than that of telotristat ethyl. Serotonin plays a role in mediating secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-produced in patients with carcinoid syndrome. Through inhibition of tryptophan hydroxylase, telotristat and telotristat ethyl reduce the production of peripheral serotonin, and the frequency of carcinoid syndrome diarrhea.

Source: US FDA prescribing information

Dosing overview

The recommended dosage of Xermelo in adult patients is 250 mg three times daily for patients whose diarrhea is inadequately controlled by SSA therapy. Administration Take Xermelo with food. When short-acting octreotide is used in combination with Xermelo, administer short-acting octreotide at least 30 minutes after administering Xermelo. If a dose is missed, take the next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose. Discontinue Xermelo if severe constipation develops. The recommended dosage of Xermelo in adult patients is 250 mg three times daily for patients whose diarrhea is inadequately controlled by a SSA therapy. Take Xermelo with food.

Source: US FDA prescribing information

Contraindications

Xermelo is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritus. History of hypersensitivity to telotristat.

Source: US FDA prescribing information

Warnings and precautions

Constipation: Xermelo reduces bowel movement frequency, monitor patients for constipation, and/or severe persistent or worsening abdominal pain. Discontinue Xermelo if constipation or abdominal pain develops.

Source: US FDA prescribing information

Side effects

Most common adverse reactions (≥5%) are nausea, headache, increased GGT, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.

Source: US FDA prescribing information

Interactions

CYP3A4 Substrates (e.g., midazolam) and CYP2B6 Substrates (e.g., bupropion, efavirenz): Efficacy of concomitant drugs may be decreased, monitor patients’ response and consider increasing the dosage of the concomitant drug, if necessary.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Telotristat ethyl, sorted by availability.

MedicineManufacturerRegisterAvailability
Xermelo 250 mg tabletOralTerSera TherapeuticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Telotristat ethyl in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Telotristat ethyl available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Telotristat ethyl and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Telotristat ethyl have?

The catalogue lists 1 brand names for Telotristat ethyl, including Xermelo.

Is Telotristat ethyl authorised in the European Union?

Yes. Telotristat ethyl has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Telotristat ethyl need cold chain shipping?

No listed presentation of Telotristat ethyl is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Telotristat ethyl in?

Telotristat ethyl is classified under ATC code A16A (Metabolic disease treatments, including enzyme replacement, subgroup A16A).

References

  1. Xermelo prescribing information (TerSera Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 6 August 2026
  2. Xermelo: European public assessment report (EPAR). European Medicines Agency. Retrieved 8 December 2025

Request Telotristat ethyl for export supply

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