Tenofovir alafenamide - PharmaKB

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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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Target

Variants

Financial

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YTD

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2Y

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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Primary completion date

Completion date

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Commercial

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

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
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

Labels

FDA

EMA

Brand Name	Status	Last Update
biktarvy	New Drug Application	2024-10-17
descovy	New Drug Application	2025-01-30
genvoya	New Drug Application	2025-02-03
odefsey	New Drug Application	2025-02-24
symtuza	New Drug Application	2024-07-23
vemlidy	New Drug Application	2024-04-04

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20
chronic hepatitis b	EFO_0004239	D019694	B18.1

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

1294 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	54	139	183	157	134	636
Hepatitis b	D006509	—	—	30	75	46	82	88	312
Hepatitis	D006505	—	K75.9	29	75	43	80	78	295
Hepatitis a	D006506	EFO_0007305	B15	22	64	37	63	66	244
Chronic hepatitis b	D019694	EFO_0004239	B18.1	25	62	33	61	67	241
Hiv	D006678	—	O98.7	28	22	41	71	46	202
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	19	37	56	27	50	178
Infections	D007239	EFO_0000544	—	8	30	47	31	30	139
Chronic hepatitis	D006521	—	K73.9	11	36	19	37	35	133
Communicable diseases	D003141	—	—	4	16	25	20	13	74

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepatitis d	D003699	EFO_0007304	—	—	7	1	—	2	10
Covid-19	D000086382	—	U07.1	—	3	6	—	2	8
Chronic hepatitis d	D019701	—	—	—	3	1	—	1	5
Disease progression	D018450	—	—	—	1	1	—	3	5
Liver transplantation	D016031	EFO_0010682	—	—	1	1	—	2	4
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	1	1	—	2	4
Coronavirus infections	D018352	EFO_0007224	B34.2	—	1	2	—	1	3
B-cell lymphoma	D016393	—	—	—	1	1	—	1	3
Hyperlipidemias	D006949	EFO_0003774	E78.5	—	—	1	—	1	2
Breast feeding	D001942	—	—	—	—	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gender identity	D005783	—	—	1	1	—	—	3	4
Behavior and behavior mechanisms	D001520	—	—	1	1	—	—	2	3
Syndrome	D013577	—	—	1	1	—	—	1	2
Biliary liver cirrhosis	D008105	—	K74.3	—	1	—	—	1	2
Pharmacokinetics	D010599	—	—	1	1	—	—	1	2
Sclerosis	D012598	—	—	1	1	—	—	—	2
Multiple sclerosis	D009103	EFO_0003885	G35	—	2	—	—	—	2
Ebola hemorrhagic fever	D019142	EFO_0007243	A98.4	—	1	—	—	—	1
Parasitemia	D018512	—	—	1	1	—	—	—	1
Pulmonary tuberculosis	D014397	EFO_1000049	A15	—	1	—	—	—	1

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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	3	—	—	—	—	3
Lipid metabolism disorders	D052439	—	—	1	—	—	—	1	2
Contraception behavior	D003268	—	—	1	—	—	—	1	2
Hepacivirus	D016174	—	—	1	—	—	—	1	2
Heart disease risk factors	D000082742	—	—	1	—	—	—	—	1
Gender dysphoria	D000068116	—	F64	1	—	—	—	—	1
Transgenes	D019076	—	—	1	—	—	—	—	1
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	1	—	—	—	—	1
Motor neuron disease	D016472	EFO_0003782	G12.2	1	—	—	—	—	1
Therapeutics	D013812	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Risk reduction behavior	D040242	—	—	—	—	—	—	4	4
Aging	D000375	GO_0007568	R41.81	—	—	—	—	3	3
Sustained virologic response	D000072230	—	—	—	—	—	—	2	2
Acute kidney injury	D058186	—	N17	—	—	—	—	2	2
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	2	2
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	—	—	2	2
Esophageal and gastric varices	D004932	EFO_0009545	I85	—	—	—	—	2	2
Self efficacy	D020377	—	—	—	—	—	—	2	2
Retinal diseases	D012164	—	H35.9	—	—	—	—	2	2
Gonorrhea	D006069	DOID_7551	A54	—	—	—	—	2	2

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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

No data

Variants

No data

Financial

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Genvoya – Gilead Sciences

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Vemlidy – Gilead Sciences

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Descovy – Gilead Sciences

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Biktarvy – Gilead Sciences

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Odefsey – Gilead Sciences

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Estimated US medical usage

No data

Trends

PubMed Central

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Additional graphs summarizing 5,023 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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