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Fexinidazole
Fexinidazole is a small molecule pharmaceutical. Fexinidazole was first approved as Fexinidazole on 2021-07-16. It is used to treat african trypanosomiasis in the USA.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fexinidazole
Tradename
Company
Number
Date
Products
FEXINIDAZOLESanofiN-214429 RX2021-07-16
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fexinidazoleNew Drug Application2021-07-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
african trypanosomiasis—D014353B56
Agency Specific
FDA
EMA
Expiration
Code
FEXINIDAZOLE, FEXINIDAZOLE, SANOFI
2028-07-16ODE-359
2026-07-16NCE
Patent Expiration
No data
ATC Codes
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01C: Agents against leishmaniasis and trypanosomiasis
— P01CA: Nitroimidazole derivatives, antiprotozoal agents against leishmaniasis and trypanosomiasis
— P01CA03: Fexinidazole
HCPCS
No data
Clinical
Clinical Trials
13 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
African trypanosomiasisD014353B56345——8
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chagas diseaseD014355EFO_0008559B57—2———2
Visceral leishmaniasisD007898B55.0—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFEXINIDAZOLE
INNfexinidazole
Description
Fexinidazole is a medication used to treat African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense. It is effective against both first and second stage disease. Some evidence also supports its use in Chagas disease. It is taken by mouth.
Classification
Small molecule
Drug classantiprotozoal substances (metronidazole type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CSc1ccc(OCc2ncc([N+](=O)[O-])n2C)cc1
Identifiers
PDB—
CAS-ID59729-37-2
RxCUI—
ChEMBL IDCHEMBL1631694
ChEBI ID—
PubChem CID68792
DrugBankDB12265
UNII ID306ERL82IR (ChemIDplus, GSRS)
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:
Mock data
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Additional graphs summarizing 561 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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