MedPath

Telotristat

Generic Name
Telotristat
Brand Names
Xermelo
Drug Type
Small Molecule
Chemical Formula
C25H22ClF3N6O3
CAS Number
1033805-28-5
Unique Ingredient Identifier
381V4FCV2Z

Overview

A tryptophan hydroxylase inhibitor. Telotristat ethyl (brand name Xermelo) is a prodrug of telotristat.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2020/12/17
Phase 2
Withdrawn
2020/09/10
Phase 2
Terminated
Lowell Anthony, MD
2018/03/05
Phase 2
Completed
2018/02/22
Phase 1
Completed
2017/10/05
Phase 1
Completed
2017/07/21
N/A
Completed
2016/02/17
Phase 1
Completed
2014/07/21
Phase 1
Completed
2014/06/06
Phase 1
Completed
2014/06/06
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
9/17/2017

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
XERMELO telotristat ethyl (as telotristat etiprate) 250 mg film-coated tablet blister pack
291734
Medicine
A
9/14/2018

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