Cabenuva kit, Vocabria(cabotegravir)
Apretude, Cabenuva, Vocabria (cabotegravir) is a small molecule pharmaceutical. Cabotegravir was first approved as Vocabria on 2020-12-17. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Apretude, Vocabria
CombinationsCabenuva
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cabotegravir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| APRETUDE | ViiV Healthcare | N-215499 RX | 2021-12-20 | 1 products, RLD, RS |
Cabotegravir
+
Rilpivirine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CABENUVA KIT | ViiV Healthcare | N-212888 RX | 2021-01-21 | 2 products, RLD, RS |
Cabotegravir sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOCABRIA | ViiV Healthcare | N-212887 RX | 2021-01-21 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CABOTEGRAVIR, APRETUDE, VIIV HLTHCARE | |||
| 2026-01-21 | NCE | ||
CABOTEGRAVIR / RILPIVIRINE, CABENUVA KIT, VIIV HLTHCARE | |||
| 2026-01-21 | NCE | ||
| 2025-03-29 | NPP | ||
| 2025-01-31 | D-184 | ||
CABOTEGRAVIR SODIUM, VOCABRIA, VIIV HLTHCARE | |||
| 2026-01-21 | NCE | ||
| 2025-03-29 | NPP | ||
| 2025-01-31 | M-273 | ||
Patent Expiration
HCPCS
Code | Description |
|---|---|
| J0741 | Injection, cabotegravir and rilpivirine, 2mg/3mg |
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 10 | 8 | 8 | 3 | 4 | 31 |
| Hiv | D006678 | O98.7 | — | 1 | 1 | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | 15 | 3 | 1 | — | 1 | 20 | |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | 1 | — | — | — | — | 1 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 1 | 1 |
| Contraception | D003267 | — | — | — | — | 1 | 1 | ||
| Drug interactions | D004347 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CABOTEGRAVIR |
| INN | cabotegravir |
| Description | Cabotegravir is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of (3S,11aR)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxylic acid with the amino group of 2,4-difluorobenzylamine. Used (as its sodium salt) for treatment of HIV-1. It has a role as a HIV-1 integrase inhibitor. It is a difluorobenzene, a secondary carboxamide, a monocarboxylic acid amide and an organic heterotricyclic compound. It is a conjugate acid of a cabotegravir(1-). |
| Classification | Small molecule |
| Drug class | antivirals: integrase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H]1CO[C@@H]2Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N12 |
Identifiers
| PDB | — |
| CAS-ID | 1051375-10-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2403238 |
| ChEBI ID | — |
| PubChem CID | 54713659 |
| DrugBank | DB11751 |
| UNII ID | HMH0132Z1Q (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:
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Safety
Black-box Warning
Black-box warning for: Apretude
Adverse Events
Top Adverse Reactions
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2,463 adverse events reported
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