Xermelo(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 | 2022-10-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diarrhea | HP_0002014 | D003967 | R19.7 |
| malignant carcinoid syndrome | — | D008303 | E34.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TELOTRISTAT ETIPRATE, XERMELO, TERSERA | |||
| 2024-02-28 | ODE-132 | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoid tumor | D002276 | — | D3A.00 | 1 | 6 | 4 | — | 1 | 12 |
| Malignant carcinoid syndrome | D008303 | — | E34.0 | 1 | 5 | 4 | — | 1 | 11 |
| Serotonin syndrome | D020230 | EFO_1001842 | — | 1 | 5 | 4 | — | 1 | 11 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 5 | 2 | — | 1 | 8 |
| Syndrome | D013577 | — | — | — | 4 | 3 | — | — | 7 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 2 |
| Neuroendocrine carcinoma | D018278 | — | — | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
| Carcinoid heart disease | D002275 | EFO_1001769 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | 1 | 2 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | 1 | — | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 4 | — | — | — | — | 4 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cachexia | D002100 | HP_0004326 | R64 | — | — | — | — | 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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Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 186 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,833 adverse events reported
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