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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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FDA approval date
EMA approval date
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Study first post date
Last update 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 Application2024-10-17
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
73907912025-04-17DS, 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
104 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_0000764B2051829291389
HivD006678——1—57114
Acquired immunodeficiency syndromeD000163EFO_0000765B20—246113
InfectionsD007239EFO_0000544——425—11
Communicable diseasesD003141———4—3—7
CoinfectionD060085———112—4
TuberculosisD014376EFO_0000774A15-A19—1—113
HepatitisD006505HP_0012115K75.9———2—2
Hiv seropositivityD006679—————2—2
Hepatitis bD006509————11—2
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic syndromeD024821EFO_0000195E88.810——1—12
FastingD005215EFO_0002756———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A15—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Renal insufficiencyD051437HP_0000083N191————1
Insulin resistanceD007333HP_0000855—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——————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
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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
$
€
£
₣
Biktarvy – Gilead Sciences
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,913 documents
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Safety
Black-box Warning
Black-box warning for: Biktarvy
Adverse Events
Top Adverse Reactions
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6,558 adverse events reported
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