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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
neoplasmsD009369
signs and symptoms pathological conditionsD013568
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
XERMELOTerSera TherapeuticsN-208794 RX2017-02-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xermeloNew Drug Application2022-10-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
diarrheaHP_0002014D003967R19.7
malignant carcinoid syndrome—D008303E34.0
Agency Specific
FDA
EMA
Expiration
Code
TELOTRISTAT ETIPRATE, XERMELO, TERSERA
2024-02-28ODE-132
Patent Expiration
Patent
Expires
Flag
FDA Information
Telotristat Etiprate, Xermelo, Tersera
77094932031-02-28DPU-1979
81932042031-02-27DP
86530942028-12-19U-1979
75538402027-12-11DP
79685592027-12-11U-1979
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic bronchitisD029481J42———6—6
PneumoniaD011014EFO_0003106J18—113—5
Healthy volunteers/patients————2—2
Maxillary sinusitisD015523EFO_0007361J32.0——11—2
Respiratory tract infectionsD012141J06.9———2—2
Bacterial pneumoniaD018410EFO_1001272J15.9———1—1
SinusitisD012852EFO_0007486J32———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Otitis mediaD010033EFO_0004992H66.9——2——2
PharyngitisD010612R07.0——2——2
TonsillitisD014069HP_0011110J03——2——2
Suppurative otitis mediaD010035EFO_0007503H66——1——1
Scrub typhusD012612EFO_0007480A75.3——1——1
InfectionsD007239EFO_0000544——1——1
AsthmaD001249EFO_0000270J45——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chemical and drug induced liver injuryD056486————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTELOTRISTAT 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 classenzyme 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-ID1033805-22-9
RxCUI1872441
ChEMBL IDCHEMBL3348963
ChEBI ID—
PubChem CID25181577
DrugBankDB12095
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 172 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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3,966 adverse events reported
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