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Brincidofovir
Tembexa (brincidofovir) is a small molecule pharmaceutical. Brincidofovir was first approved as Tembexa on 2021-06-04. It is used to treat smallpox in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Tembexa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Brincidofovir
Tradename
Company
Number
Date
Products
TEMBEXAEmergent BioDefense Operations LansingN-214460 RX2021-06-04
1 products, RLD, RS
TEMBEXAEmergent BioDefense Operations LansingN-214461 RX2021-06-04
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tembexaNew Drug Application2023-02-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
smallpox—D012899B03
Agency Specific
FDA
EMA
Expiration
Code
BRINCIDOFOVIR, TEMBEXA, EMERGENT BIODEFENSE
2028-06-04ODE-354
2024-06-04NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Brincidofovir, Tembexa, Emergent Biodefense
89628292034-10-10DS, DP
93713442034-10-10DP
101129092034-10-10U-3165
104870612034-10-10DPU-3165
93030512031-08-31DS, DPU-3165
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
— J05AB17: Brincidofovir
HCPCS
No data
Clinical
Clinical Trials
18 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
Adenoviridae infectionsD000257EFO_1001259B34.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenoviridaeD000256—2——24
Ebola hemorrhagic feverD019142EFO_0007243A98.4—1———1
EbolavirusD029043—1———1
Cytomegalovirus infectionsD003586EFO_0001062B25—1———1
Kidney transplantationD016030—1———1
Herpesviridae infectionsD006566EFO_0007309B00.4—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Survival rateD015996————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBRINCIDOFOVIR
INNbrincidofovir
Description
Brincidofovir, sold under the brand name Tembexa, is an antiviral drug used to treat smallpox. Brincidofovir is a prodrug of cidofovir. Conjugated to a lipid, the compound is designed to release cidofovir intracellularly, allowing for higher intracellular and lower plasma concentrations of cidofovir, effectively increasing its activity against dsDNA viruses, as well as oral bioavailability.
Classification
Small molecule
Drug classantivirals
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCCCCCCCCCCCCCOCCCOP(=O)(O)CO[C@H](CO)Cn1ccc(N)nc1=O
Identifiers
PDB—
CAS-ID444805-28-1
RxCUI—
ChEMBL IDCHEMBL203321
ChEBI ID—
PubChem CID483477
DrugBankDB12151
UNII ID6794O900AX (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tembexa - Chimerix
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,130 documents
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Safety
Black-box Warning
Black-box warning for: Tembexa
Adverse Events
Top Adverse Reactions
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59 adverse events reported
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