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Drug ReportsBictegravir
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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YTD
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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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
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 Application2025-07-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
chronic hepatitis bEFO_0004239D019694B18.1
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
Patent Expiration
Patent
Expires
Flag
FDA Information
Bictegravir Sodium / Emtricitabine / Tenofovir Alafenamide Fumarate, Biktarvy, Gilead Sciences Inc
105488462036-11-08DP
117448022036-11-08DP
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
73907912025-01-07DS, 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
129 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_0000764B207102018656
Acquired immunodeficiency syndromeD000163EFO_0000765B20——24—6
HivD006678—O98.71—1316
InfectionsD007239EFO_0000544——1—214
CoinfectionD060085————12—3
Communicable diseasesD003141———1—113
TuberculosisD014376EFO_0000774A15-A19———112
Opioid-related disordersD009293EFO_0005611F11———1—1
Hepatitis cD006526—B19.2———1—1
Chronic hepatitis cD019698EFO_0004220B18.2———1—1
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.6——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
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Medication adherenceD055118EFO_0006344—————11
Cardiovascular diseasesD002318EFO_0000319I98————11
NeoplasmsD009369—C80————11
Metabolic diseasesD008659EFO_0000589E88.9————11
Retinal diseasesD012164—H35.9————11
Metabolic syndromeD024821EFO_0000195E88.810————11
OsteoporosisD010024EFO_0003882M81.0————11
Drug interactionsD004347——————11
Hiv seropositivityD006679——————11
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)Loading
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
RxCUI—
ChEMBL IDCHEMBL3989866
ChEBI ID—
PubChem CID90311989
DrugBankDB11799
UNII ID8GB79LOJ07 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Biktarvy – Gilead Sciences
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,514 documents
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Safety
Black-box Warning
Black-box warning for: Biktarvy
Adverse Events
Top Adverse Reactions
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8,093 adverse events reported
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