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AboutPricing
Drug ReportsCabotegravir
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Apretude, Vocabria
Combinations
Cabenuva
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
APRETUDEViiV HealthcareN-215499 RX2021-12-20
1 products, RLD, RS
Cabotegravir
+
Rilpivirine
Tradename
Company
Number
Date
Products
CABENUVA KITViiV HealthcareN-212888 RX2021-01-21
2 products, RLD, RS
Cabotegravir sodium
Tradename
Company
Number
Date
Products
VOCABRIAViiV HealthcareN-212887 RX2021-01-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
apretudeNew Drug Application2025-04-11
cabenuvaNew Drug Application2025-06-04
vocabriaNew Drug Application2025-04-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
Agency Specific
FDA
EMA
Expiration
Code
CABOTEGRAVIR, APRETUDE, VIIV HLTHCARE
2026-01-21NCE
CABOTEGRAVIR / RILPIVIRINE, CABENUVA KIT, VIIV HLTHCARE
2026-01-21NCE
2025-03-29NPP
2025-01-31D-184
CABOTEGRAVIR SODIUM, VOCABRIA, VIIV HLTHCARE
2026-01-21NCE
2025-03-29NPP
2025-01-31M-273
Patent Expiration
Patent
Expires
Flag
FDA Information
Cabotegravir, Apretude, Viiv Hlthcare
112245972031-09-15DPU-3348
84101032026-04-28DS, DPU-3061, U-3348
109271292026-04-28DS, DP
Cabotegravir / Rilpivirine, Cabenuva Kit, Viiv Hlthcare
113894472027-06-30U-3405
71258792025-04-21DS, DPU-3348
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AJ: Integrase inhibitors, antiinfectives for systematic use
— J05AJ04: Cabotegravir
HCPCS
Code
Description
J0739
Injection, cabotegravir, 1 mg
J0741
Injection, cabotegravir and rilpivirine, 2mg/3mg
Clinical
Clinical Trials
120 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 infectionsD015658EFO_0000764B2029182262191
HivD006678—O98.712241019
Opioid-related disordersD009293EFO_0005611F111——1—2
Substance-related disordersD019966EFO_0003890F13———2—2
Sexually transmitted diseasesD012749—A50-A64———1—1
Breast feedingD001942—————1—1
Pregnancy rateD018873—————1—1
ViremiaD014766—B34.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B201765—735
InfectionsD007239EFO_0000544—1643—124
Communicable diseasesD003141——323——8
Immunologic deficiency syndromesD007153—D84.9132——6
Hiv-1D015497————2——2
Medication adherenceD055118EFO_0006344———1—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.111———1
Postpartum periodD049590——11———1
Psychological well-beingD000092862———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A191———12
Healthy volunteers/patients———2————2
Renal insufficiencyD051437—N191————1
LipodystrophyD008060—E88.11————1
Hiv-associated lipodystrophy syndromeD039682EFO_1001348—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Patient satisfactionD017060——————22
ContraceptionD003267——————11
Drug interactionsD004347——————11
Hiv seropositivityD006679——————11
InflammationD007249MP_0001845—————11
Disease progressionD018450——————11
Psychological traumaD000067073——————11
Patient acceptance of health careD010342——————11
Patient preferenceD057240——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCabotegravir
INNcabotegravir
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 classantivirals: integrase inhibitors
Image (chem structure or protein)Loading
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-ID1051375-10-0
RxCUI—
ChEMBL IDCHEMBL2403238
ChEBI ID—
PubChem CID54713659
DrugBankDB11751
UNII IDHMH0132Z1Q (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 2,961 documents
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Safety
Black-box Warning
Black-box warning for: Apretude
Adverse Events
Top Adverse Reactions
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13,134 adverse events reported
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