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AboutPricing
Drug ReportsFexinidazole
Fexinidazole
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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3M
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YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Fexinidazole
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 Application2025-05-02
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
14 clinical trials
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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
TrypanosomiasisD014352DOID_10113B57.2355—110
African trypanosomiasisD014353—B56345—19
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chagas diseaseD014355EFO_0008559B57—2———2
Visceral leishmaniasisD007898—B55.0—1———1
LeishmaniasisD007896EFO_0005044B55—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107EFO_0001421K70-K771————1
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. Also a potential new treatment for Chagas disease, a neglected tropical disease that affects millions of people worldwide. It is taken by mouth.
Classification
Small molecule
Drug classantiprotozoal substances (metronidazole type)
Image (chem structure or protein)Loading
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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 771 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8 adverse events reported
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