Genvoya(tenofovir alafenamide)
Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Vemlidy (tenofovir alafenamide) is a small molecule pharmaceutical. Tenofovir alafenamide was first approved as Genvoya on 2015-11-05. It is used to treat chronic hepatitis b in the USA. It has been approved in Europe to treat hepatitis b and HIV infections.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| digestive system diseases | D004066 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Vemlidy (generic drugs available since 2023-03-30)
CombinationsBiktarvy, Descovy, Genvoya, Odefsey, Symtuza
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 |
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMTUZA | Johnson & Johnson | N-210455 RX | 2018-07-17 | 1 products, RLD, RS |
Cobicistat
+
Elvitegravir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GENVOYA | Gilead Sciences | N-207561 RX | 2015-11-05 | 1 products, RLD, RS |
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ODEFSEY | Gilead Sciences | N-208351 RX | 2016-03-01 | 1 products, RLD, RS |
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DESCOVY | Gilead Sciences | N-208215 RX | 2016-04-04 | 2 products, RLD, RS |
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VEMLIDY | Gilead Sciences | N-208464 RX | 2016-11-10 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis b | EFO_0004239 | D019694 | B18.1 |
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 | ||
TENOFOVIR ALAFENAMIDE FUMARATE, VEMLIDY, GILEAD SCIENCES INC | |||
| 2025-10-17 | NPP | ||
| 2023-08-22 | M-266 | ||
| 2023-02-04 | M-255 | ||
EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, DESCOVY, GILEAD SCIENCES INC | |||
| 2024-09-28 | ODE-284, ODE-285 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods | |||
| 10786518 | 2038-07-19 | U-2978 | |
| 10039718 | 2032-10-06 | DP | |
| 8148374 | 2029-09-03 | DS, DP | U-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768 |
| 7700645 | 2026-12-26 | DS, DP | |
| 8518987 | 2024-02-16 | DS, DP | |
| 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, U-999, U-1259, U-1275, U-1663, U-2352, U-2765 |
| 9296769 | 2032-08-15 | DS, DP | U-257, U-999, U-1259, U-1275, U-1663, U-2352, U-2765 |
| 7390791 | 2025-04-17 | DS, DP | |
| Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Alafenamide Fumarate, Genvoya, Gilead Sciences Inc | |||
| 8633219 | 2030-04-30 | DP | U-257 |
| 9891239 | 2029-09-03 | DP | U-257 |
| 7635704 | 2026-10-26 | DS, DP | U-257 |
| 8981103 | 2026-10-26 | DS, DP | |
| 7176220 | 2026-08-27 | DS, DP | U-257 |
| Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc | |||
| 7125879 | 2025-04-21 | DS, DP | U-257 |
| 8080551 | 2023-04-11 | DS, DP | |
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
— J05AF13: Tenofovir alafenamide
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR17: Emtricitabine and tenofovir alafenamide
— J05AR18: Emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat
— J05AR19: Emtricitabine, tenofovir alafenamide and rilpivirine
— J05AR20: Emtricitabine, tenofovir alafenamide and bictegravir
— J05AR22: Emtricitabine, tenofovir alafenamide, darunavir and cobicistat
HCPCS
No data
Clinical
Clinical Trials
682 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 infections | D015658 | EFO_0000764 | B20 | 26 | 63 | 62 | 71 | 47 | 257 |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 13 | 25 | 17 | 39 | 28 | 118 |
| Hiv | D006678 | O98.7 | 15 | 9 | 12 | 39 | 13 | 86 | |
| Hepatitis b | D006509 | 6 | 15 | 8 | 16 | 13 | 56 | ||
| Healthy volunteers/patients | — | 22 | — | — | 7 | 2 | 31 | ||
| Infections | D007239 | EFO_0000544 | — | 3 | 4 | 2 | — | 9 | |
| Medication adherence | D055118 | EFO_0006344 | 3 | 1 | 2 | 2 | 1 | 9 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 3 | 1 | 4 | 8 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 3 | 2 | 2 | — | 7 |
| Hepatitis c | D006526 | B19.2 | 2 | 1 | — | 1 | 3 | 7 |
Show 40 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | 2 | 3 | — | 2 | 9 |
| Covid-19 | D000086382 | U07.1 | — | 3 | 5 | — | 1 | 6 | |
| Sars-cov-2 | D000086402 | — | 1 | 2 | — | — | 2 | ||
| Chronic hepatitis d | D019701 | — | 1 | 1 | — | — | 2 | ||
| Lymphoma | D008223 | C85.9 | 1 | 1 | 1 | — | — | 2 | |
| Treatment adherence and compliance | D000074822 | — | — | 2 | — | — | 2 | ||
| Breast feeding | D001942 | — | — | 1 | — | — | 1 | ||
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | 1 | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | 1 | — | — | 1 | ||
| Disease progression | D018450 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis d | D003699 | EFO_0007304 | — | 4 | — | — | — | 4 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | 1 | 2 |
| Lipodystrophy | D008060 | E88.1 | — | 2 | — | — | — | 2 | |
| Parasitemia | D018512 | 1 | 1 | — | — | — | 1 | ||
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | — | — | — | 1 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | 1 | — | — | — | 1 |
| Biliary liver cirrhosis | D008105 | K74.3 | — | 1 | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 1 | — | — | — | 1 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | — | 1 | — | — | — | 1 | |
| Chronic hepatitis | D006521 | K73.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | 1 | — | — | — | 1 | 2 | ||
| Contraception | D003267 | 1 | — | — | — | 1 | 2 | ||
| Gender dysphoria | D000068116 | F64 | 1 | — | — | — | — | 1 | |
| Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | — | 1 | |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | 2 | 2 | ||
| Sustained virologic response | D000072230 | — | — | — | — | 1 | 1 | ||
| Job syndrome | D007589 | EFO_0003775 | D82.4 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Liver failure | D017093 | HP_0001399 | K72.9 | — | — | — | — | 1 | 1 |
| Virus diseases | D014777 | B34 | — | — | — | — | 1 | 1 | |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 1 | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | — | 1 | 1 |
Show 8 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TENOFOVIR ALAFENAMIDE |
| INN | tenofovir alafenamide |
| Description | Tenofovir alafenamide is an L-alanine derivative that is isopropyl L-alaninate in which one of the amino hydrogens is replaced by an (S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl group. A prodrug for tenofovir, it is used (as the fumarate salt) in combination therapy for the treatment of HIV-1 infection. It has a role as an antiviral drug, a HIV-1 reverse transcriptase inhibitor and a prodrug. It is a L-alanine derivative, a phosphoramidate ester, an ether, a member of 6-aminopurines and an isopropyl ester. It is functionally related to an adenine. It is a conjugate base of a tenofovir alafenamide(1+). |
| Classification | Small molecule |
| Drug class | antivirals |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)Oc1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 379270-37-8 |
| RxCUI | 1721603 |
| ChEMBL ID | CHEMBL2107825 |
| ChEBI ID | — |
| PubChem CID | 9574768 |
| DrugBank | DB09299 |
| UNII ID | EL9943AG5J (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
Genvoya - Gilead Sciences
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Descovy - Gilead Sciences
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Vemlidy - Gilead Sciences
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Biktarvy - Gilead Sciences
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Odefsey - Gilead Sciences
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Tabular view
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Vemlidy
Adverse Events
Top Adverse Reactions
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5,850 adverse events reported
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