Vemlidy(tenofovir alafenamide)
Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Tenofovir Alafenamide, 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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Commercial
Trade Name
FDA
EMA
Tenofovir alafenamide, Vemlidy (discontinued: Tenofovir alafenamide)
CombinationsBiktarvy, Descovy, Emtricitabine tenofovir alafenamide, Genvoya, Odefsey, Symtuza (discontinued: Emtricitabine tenofovir alafenamide, Emtricitabine, rilpivirine, tenofovir alafenamide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMTUZA | Johnson & Johnson | N-210455 RX | 2018-07-17 | 1 products, RLD, RS |
Bictegravir sodium
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BIKTARVY | Gilead Sciences | N-210251 RX | 2018-02-07 | 2 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 |
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 |
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VEMLIDY | Gilead Sciences | N-208464 RX | 2016-11-10 | 1 products, RLD, RS |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, DESCOVY, GILEAD SCIENCES INC | |||
| 2029-01-07 | ODE-457 | ||
| 2024-09-28 | ODE-284, ODE-285 | ||
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 | ||
TENOFOVIR ALAFENAMIDE FUMARATE, VEMLIDY, GILEAD SCIENCES INC | |||
| 2025-10-17 | NPP | ||
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 | |
| Bictegravir Sodium / Emtricitabine / Tenofovir Alafenamide Fumarate, Biktarvy, Gilead Sciences Inc | |||
| 10548846 | 2036-11-08 | DP | |
| 11744802 | 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, U-3880 |
| 9296769 | 2032-08-15 | DS, DP | U-257, U-999, U-1259, U-1275, U-1663, U-2352, U-2765, U-3880 |
| 7390791 | 2025-01-07 | 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 |
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
1372 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 | 11 | 43 | 76 | 50 | 18 | 182 |
| Hiv | D006678 | — | O98.7 | 2 | 6 | 16 | 21 | 8 | 49 |
| Hepatitis b | D006509 | — | — | 2 | 13 | 16 | 13 | 5 | 48 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 7 | 20 | 16 | 4 | 43 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 15 | 14 | 9 | 4 | 43 |
| Hepatitis | D006505 | — | K75.9 | 1 | 10 | 12 | 12 | 5 | 40 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 7 | 8 | 8 | 4 | 28 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 7 | 5 | 5 | 4 | 22 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 4 | 3 | 4 | 11 |
| Medication adherence | D055118 | EFO_0006344 | — | — | 1 | 1 | 2 | 2 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b virus | D006515 | — | — | 1 | 1 | 1 | — | 1 | 4 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | 2 | — | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | — | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | 1 | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | 1 | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | 1 | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
| Breast feeding | D001942 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Chronic hepatitis d | D019701 | — | — | — | 1 | — | — | — | 1 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 1 | — | — | — | 1 |
| Patient acceptance of health care | D010342 | — | — | — | 1 | — | — | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | 1 | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | 1 | — | — | — | 1 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv seropositivity | D006679 | — | — | — | — | — | — | 3 | 3 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | — | — | — | — | 1 | 1 |
| Patient satisfaction | D017060 | — | — | — | — | — | — | 1 | 1 |
| Job syndrome | D007589 | EFO_0003775 | D82.4 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
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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 | — |
| ChEMBL ID | CHEMBL2107825 |
| ChEBI ID | — |
| PubChem CID | 9574768 |
| DrugBank | DB09299 |
| UNII ID | EL9943AG5J (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Odefsey – Gilead Sciences
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Biktarvy – Gilead Sciences
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Vemlidy – Gilead Sciences
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Descovy – Gilead Sciences
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Genvoya – Gilead Sciences
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Tabular view
Estimated US medical usage
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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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21,417 adverse events reported
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