Telotristat etiprate
Xermelo (telotristat etiprate) is a small molecule pharmaceutical. Telotristat etiprate was first approved as Xermelo on 2017-02-28. It is used to treat diarrhea and malignant carcinoid syndrome in the USA. It has been approved in Europe to treat carcinoid tumor and neuroendocrine tumors.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Xermelo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Telotristat etiprate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XERMELO | TerSera Therapeutics | N-208794 RX | 2017-02-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xermelo | New Drug Application | 2025-10-01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TELOTRISTAT ETIPRATE, XERMELO, TERSERA | |||
| 2024-02-28 | ODE-132 | ||
ATC Codes
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HCPCS
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Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoid tumor | D002276 | — | D3A.00 | — | — | — | — | 1 | 1 |
| Malignant carcinoid syndrome | D008303 | — | E34.0 | — | — | — | — | 1 | 1 |
| Serotonin syndrome | D020230 | EFO_1001842 | G90.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Telotristat etiprate |
| INN | — |
| Description | Telotristat ethyl (USAN, brand name Xermelo) is a prodrug of telotristat, which is an inhibitor of tryptophan hydroxylase. It is formulated as telotristat etiprate — a hippurate salt of telotristat ethyl.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors: tryptophan hydroxylase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)[C@@H](N)Cc1ccc(-c2cc(O[C@H](c3ccc(Cl)cc3-n3ccc(C)n3)C(F)(F)F)nc(N)n2)cc1.O=C(O)CNC(=O)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 1033805-22-9 |
| RxCUI | 1872441 |
| ChEMBL ID | CHEMBL3348963 |
| ChEBI ID | — |
| PubChem CID | 25181577 |
| DrugBank | DB12095 |
| UNII ID | — |
Target
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Safety
Black-box Warning
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Adverse Events
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1,899 adverse events reported
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