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 |
|---|---|
| infections | D007239 |
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 |
|---|---|---|---|---|
| TEMBEXA | Emergent BioDefense Operations Lansing | N-214460 RX | 2021-06-04 | 1 products, RLD, RS |
| TEMBEXA | Emergent BioDefense Operations Lansing | N-214461 RX | 2021-06-04 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tembexa | New Drug Application | 2025-07-23 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BRINCIDOFOVIR, TEMBEXA, EMERGENT BIODEFENSE | |||
| 2028-06-04 | ODE-354 | ||
| 2024-06-04 | NP | ||
HCPCS
No data
Clinical
Clinical Trials
22 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 |
|---|---|---|---|---|---|---|---|---|---|
| Adenoviridae infections | D000257 | EFO_1001259 | B34.0 | — | 4 | 1 | — | 2 | 7 |
| Infections | D007239 | EFO_0000544 | — | — | 3 | 2 | — | — | 5 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | 2 | 2 | — | — | 4 |
| Communicable diseases | D003141 | — | — | — | 3 | 1 | — | — | 4 |
| Virus diseases | D014777 | — | B34 | — | 3 | 1 | — | — | 4 |
| Kidney transplantation | D016030 | — | — | — | 1 | 1 | — | — | 2 |
| Dna viruses | D004267 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenoviridae | D000256 | — | — | — | 2 | — | — | 2 | 4 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | — | 2 | — | — | — | 2 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | 1 | — | — | — | 1 |
| Herpes simplex | D006561 | — | B00 | 1 | 1 | — | — | — | 1 |
| Simplexvirus | D018139 | — | — | 1 | 1 | — | — | — | 1 |
| Ebolavirus | D029043 | — | — | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | 1 | — | — | — | 1 |
| Viremia | D014766 | — | B34.9 | — | 1 | — | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Smallpox | D012899 | — | B03 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Survival rate | D015996 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Brincidofovir |
| INN | brincidofovir |
| 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 class | antivirals |
| 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-ID | 444805-28-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL203321 |
| ChEBI ID | — |
| PubChem CID | 483477 |
| DrugBank | DB12151 |
| UNII ID | 6794O900AX (ChemIDplus, GSRS) |
Target
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Variants
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Tembexa – Chimerix
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 1,897 documents
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Safety
Black-box Warning
Black-box warning for: Tembexa
Adverse Events
Top Adverse Reactions
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91 adverse events reported
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