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.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|
| BIKTARVY | Gilead Sciences | N-210251 RX | 2018-02-07 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| biktarvy | New Drug Application | 2022-11-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BICTEGRAVIR SODIUM / EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, BIKTARVY, GILEAD SCIENCES INC | |||
| 2028-10-07 | ODE-378 | ||
| 2026-06-18 | ODE-256 | ||
| 2024-02-24 | M-82 | ||
| 2023-02-07 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bictegravir Sodium / Emtricitabine / Tenofovir Alafenamide Fumarate, Biktarvy, Gilead Sciences Inc | |||
| 10548846 | 2036-11-08 | DP | |
| 9708342 | 2035-06-19 | DS, DP | |
| 10385067 | 2035-06-19 | U-257 | |
| 9216996 | 2033-12-19 | DS, DP | |
| 9732092 | 2033-12-19 | DS, DP | |
| 8754065 | 2032-08-15 | DS, DP | U-257 |
| 9296769 | 2032-08-15 | DS, DP | U-257 |
| 7390791 | 2025-04-17 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
51 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 2 | 5 | 15 | 6 | 29 |
| Hiv | D006678 | O98.7 | 1 | — | 2 | 6 | — | 9 | |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | 1 | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | — | 1 | — | 1 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | 1 | — | 1 | |
| Coinfection | D060085 | — | — | — | 1 | — | 1 | ||
| Harm reduction | D040261 | — | — | — | 1 | — | 1 | ||
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 1 | |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 1 | — | 1 | |
| Hiv seropositivity | D006679 | — | — | — | 1 | — | 1 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medication adherence | D055118 | EFO_0006344 | — | — | 1 | — | — | 1 | |
| Treatment adherence and compliance | D000074822 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 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 |
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 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | BICTEGRAVIR |
| INN | bictegravir |
| 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 class | antivirals: 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-ID | 1611493-60-7 |
| RxCUI | 1999660 |
| ChEMBL ID | CHEMBL3989866 |
| ChEBI ID | — |
| PubChem CID | 90311989 |
| DrugBank | DB11799 |
| UNII ID | 8GB79LOJ07 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Biktarvy - Gilead Sciences
$
€
£
₣
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1,308 documents
View more details
Safety
Black-box Warning
Black-box warning for: Biktarvy
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
838 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more