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Biktarvy(bictegravir)
Biktarvy (bictegravir) is a small molecule pharmaceutical. Bictegravir was first approved as Biktarvy on 2018-02-07. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Combinations
Biktarvy
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bictegravir sodium
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
BIKTARVYGilead SciencesN-210251 RX2018-02-07
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
biktarvyNew Drug Application2022-11-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
Agency Specific
FDA
EMA
Expiration
Code
BICTEGRAVIR SODIUM / EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, BIKTARVY, GILEAD SCIENCES INC
2028-10-07ODE-378
2026-06-18ODE-256
2024-02-24M-82
2023-02-07NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Bictegravir Sodium / Emtricitabine / Tenofovir Alafenamide Fumarate, Biktarvy, Gilead Sciences Inc
105488462036-11-08DP
97083422035-06-19DS, DP
103850672035-06-19U-257
92169962033-12-19DS, DP
97320922033-12-19DS, DP
87540652032-08-15DS, DPU-257
92967692032-08-15DS, DPU-257
73907912025-04-17DS, DP
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AR: Antivirals for treatment of hiv infections, combinations
J05AR20: Emtricitabine, tenofovir alafenamide and bictegravir
HCPCS
No data
Clinical
Clinical Trials
51 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_0000764B2022515629
HivD006678O98.71269
Opioid-related disordersD009293EFO_0005611F1111
Chronic hepatitis cD019698EFO_0004220B18.211
Metabolic bone diseasesD001851HP_000093811
CoinfectionD06008511
Harm reductionD04026111
InfectionsD007239EFO_000054411
Coronary artery diseaseD003324I25.111
Hiv seropositivityD00667911
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Medication adherenceD055118EFO_000634411
Treatment adherence and complianceD00007482211
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A1511
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients22
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A1911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBICTEGRAVIR
INNbictegravir
Description
Bictegravir is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2R,5S,13aR)-8-hydroxy-7,9-dioxo-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxylic acid with the amino group of 2,4,6-trifluorobenzylamine. It is a second-generation integrase strand transfer inhibitor (INSTI) and used (as its sodium salt) for the treatment of HIV-1. It has a role as a HIV-1 integrase inhibitor. It is a monocarboxylic acid amide, a secondary carboxamide, a trifluorobenzene and an organic heterotetracyclic compound. It is a conjugate acid of a bictegravir(1-).
Classification
Small molecule
Drug classantivirals: integrase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Identifiers
PDB
CAS-ID1611493-60-7
RxCUI1999660
ChEMBL IDCHEMBL3989866
ChEBI ID
PubChem CID90311989
DrugBankDB11799
UNII ID8GB79LOJ07 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Biktarvy - Gilead Sciences
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,308 documents
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Safety
Black-box Warning
Black-box warning for: Biktarvy
Adverse Events
Top Adverse Reactions
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838 adverse events reported
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