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Drug ReportsTenofovir alafenamide
Genvoya(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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
urogenital diseasesD000091642
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Tenofovir alafenamide, Vemlidy (discontinued: Tenofovir alafenamide)
Combinations
Biktarvy, Descovy, Emtricitabine tenofovir alafenamide, Genvoya, Odefsey, Symtuza (discontinued: Emtricitabine 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
SYMTUZAJohnson & JohnsonN-210455 RX2018-07-17
1 products, RLD, RS
Bictegravir sodium
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
BIKTARVYGilead SciencesN-210251 RX2018-02-07
2 products, RLD, RS
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
DESCOVYGilead SciencesN-208215 RX2016-04-04
2 products, RLD, RS
Cobicistat
+
Elvitegravir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
GENVOYAGilead SciencesN-207561 RX2015-11-05
1 products, RLD, RS
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
ODEFSEYGilead SciencesN-208351 RX2016-03-01
1 products, RLD, RS
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
VEMLIDYGilead SciencesN-208464 RX2016-11-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
biktarvyNew Drug Application2025-01-15
descovyNew Drug Application2025-02-07
genvoyaNew Drug Application2025-02-14
odefseyNew Drug Application2025-02-24
symtuzaNew Drug Application2024-07-23
vemlidyNew Drug Application2024-04-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
acquired immunodeficiency syndromeEFO_0000765D000163B20
chronic hepatitis bEFO_0004239D019694B18.1
Agency Specific
FDA
EMA
Expiration
Code
EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, DESCOVY, GILEAD SCIENCES INC
2029-01-07ODE-457
2024-09-28ODE-284, ODE-285
BICTEGRAVIR SODIUM / EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, BIKTARVY, GILEAD SCIENCES INC
2028-10-07ODE-378
2026-06-18ODE-256
2024-02-24M-82
TENOFOVIR ALAFENAMIDE FUMARATE, VEMLIDY, GILEAD SCIENCES INC
2025-10-17NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods
107865182038-07-19U-2978
100397182032-10-06DP
81483742029-09-03DS, DPU-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768
77006452026-12-26DS, DP
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, U-999, U-1259, U-1275, U-1663, U-2352, U-2765, U-3880
92967692032-08-15DS, DPU-257, U-999, U-1259, U-1275, U-1663, U-2352, U-2765, U-3880
73907912025-01-07DS, DP
Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Alafenamide Fumarate, Genvoya, Gilead Sciences Inc
86332192030-04-30DPU-257
98912392029-09-03DPU-257
76357042026-10-26DS, DPU-257
89811032026-10-26DS, DP
71762202026-08-27DS, DPU-257
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc
71258792025-04-21DS, DPU-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
1293 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_0000764B20—183—12
Hiv-1D015497——2121—6
InfectionsD007239EFO_0000544——111—3
Weight gainD015430—————1—1
ObesityD009765EFO_0001073E66.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B20—16——7
Immunologic deficiency syndromesD007153—D84.9——5——5
HivD006678—O98.7—11——2
Communicable diseasesD003141———11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis bD006509——39———12
Chronic hepatitis bD019694EFO_0004239B18.138———11
HepatitisD006505—K75.929———11
Hepatitis aD006506EFO_0007305B1529———11
Virus diseasesD014777—B3416———7
Herpesviridae infectionsD006566EFO_0007309B00.416———7
Chronic hepatitis dD019701———1———1
Hepatitis dD003699EFO_0007304——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———7————7
Crush injuriesD000071576—T14.81————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTenofovir alafenamide
INNtenofovir 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+).
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Classification
Small molecule
Drug classantivirals
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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-ID379270-37-8
RxCUI—
ChEMBL IDCHEMBL2107825
ChEBI ID—
PubChem CID9574768
DrugBankDB09299
UNII IDEL9943AG5J (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Odefsey – Gilead Sciences
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Vemlidy – Gilead Sciences
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Genvoya – Gilead Sciences
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Biktarvy – Gilead Sciences
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Descovy – Gilead Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,942 documents
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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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18,124 adverse events reported
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