Tenofovir alafenamide fumarate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Tenofovir alafenamide fumarate
- Molecular weight
- 1,069.02
- Structure (SMILES)
- CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)Oc1ccccc1.CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)Oc1ccccc1.O=C(O)/C=C/C(=O)O
- tenofovir alafenamide fumarate component of biktarvy
- Tenofovir alafenamide fumarate component of biktarvy
- tenofovir alafenamide fumarate component of descovy
- Tenofovir alafenamide fumarate component of descovy
- tenofovir alafenamide fumarate component of genvoya
- Tenofovir alafenamide fumarate component of genvoya
- tenofovir alafenamide fumarate component of odefsey
- Tenofovir alafenamide fumarate component of odefsey
- tenofovir alafenamide fumarate component of symtuza
- Tenofovir alafenamide fumarate component of symtuza
- vemlidy
- Vemlidy
- 1 methylethyl n s 1r 2 6 amino 9h purin 9 yl 1 methylethoxy methyl phenoxyphosphinoyl l alaninate 2e 2 butenedioate
- 1-METHYLETHYL N-((S)-(((1R)-2-(6-AMINO-9H-PURIN-9-YL)-1-METHYLETHOXY)METHYL(PHENOXYPHOSPHINOYL)-L-ALANINATE, (2E)-2-BUTENEDIOATE
- azvudine tablets fnc and tenofovir alafenol fumarate tablets taf
- biktarvy component tenofovir alafenamide fumarate
- BIKTARVY COMPONENT TENOFOVIR ALAFENAMIDE FUMARATE
- descovy component tenofovir alafenamide fumarate
- DESCOVY COMPONENT TENOFOVIR ALAFENAMIDE FUMARATE
- gs 7340 03
- gs 7340 hemifumarate
- GS-7340 HEMIFUMARATE
- GS-7340-03
- l alanine n s 1r 2 6 amino 9h purin 9 yl 1 methylethoxy methyl phenoxyphosphinyl 1 methylethyl ester 2e 2 butenedioate 2 1
- L-ALANINE, N-((S)-(((1R)-2-(6-AMINO-9H-PURIN-9-YL)-1-METHYLETHOXY)METHYL)PHENOXYPHOSPHINYL)-, 1-METHYLETHYL ESTER, (2E)-2-BUTENEDIOATE (2:1)
- odefsey component tenofovir alafenamide fumarate
- ODEFSEY COMPONENT TENOFOVIR ALAFENAMIDE FUMARATE
- symtuza component tenofovir alafenamide fumarate
- SYMTUZA COMPONENT TENOFOVIR ALAFENAMIDE FUMARATE
- taf
- TAF
- TAF 25mg
- tenofovir alafenamide fumarate
- Tenofovir alafenamide fumarate
- TENOFOVIR ALAFENAMIDE FUMARATE (2:1)
- TENOFOVIR ALAFENAMIDE FUMARATE [JAN]
- TENOFOVIR ALAFENAMIDE FUMARATE [MI]
And 13 more, listed on the interactive page.
- CAS registry numbers
- 1392275-56-7
- ChEMBL ID
- CHEMBL2364637
- InChIKey
- SVUJNSGGPUCLQZ-FQQAACOVSA-N
- PubChem compound IDs
- 71492247
- RxNorm IDs (RxCUI)
- 1721604
- FDA ingredient codes (UNII)
- FWF6Q91TZO
- Applicant
- GILEAD SCIENCES INC
- Approval date
- 5 Nov 2015
- Application number
- NDA207561
- Patents
- 4
- Designations
- 0
- Earliest recorded loss of exclusivity
- 15 Feb 2033
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Drug name stem
- -vir
Administration routes
- Oral
Mechanisms of action
- Mechanism
- Human immunodeficiency virus type 1 reverse transcriptase inhibitor
- Action type
- Inhibitor
- Target
- Human immunodeficiency virus type 1 reverse transcriptase
- Protein identifier
- Q72547
Open Targets mechanisms
- Mechanism
- Human immunodeficiency virus type 1 reverse transcriptase inhibitor
- Action type
- Inhibitor
- Target
- Human immunodeficiency virus type 1 reverse transcriptase
- Condition
- HIV Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- HIV Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Acquired Immunodeficiency Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000765
- Subject identifier
- D000163
- Condition
- Hepatitis B
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004197
- Subject identifier
- D006509
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004239
- Subject identifier
- D019694
- Condition identifier
- EFO_0000180
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 4
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0004197
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004239
- Condition identifier
- HP_0001394
- Condition identifier
- MONDO_0004790
- Condition identifier
- MONDO_0005109
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005301
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005344
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005366
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007256
- Highest recorded phase
- 1
Warnings
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Country
- United States
- Event
- blood hiv rna increased
- Reports
- 79
- Reporting signal score
- 302.465
- Event
- cd4 lymphocytes decreased
- Reports
- 43
- Reporting signal score
- 120.376
- Event
- endotracheal intubation
- Reports
- 28
- Reporting signal score
- 73.0982
- Event
- gastrointestinal tube insertion
- Reports
- 66
- Reporting signal score
- 198.866
- Event
- gastrostomy
- Reports
- 34
- Reporting signal score
- 103.538
- Event
- genotype drug resistance test positive
- Reports
- 38
- Reporting signal score
- 110.323
- Event
- immune reconstitution inflammatory syndrome
- Reports
- 80
- Reporting signal score
- 190.752
- Event
- product dispensing error
- Reports
- 93
- Reporting signal score
- 212.365
- Event
- viraemia
- Reports
- 30
- Reporting signal score
- 92.5175
- Event
- viral load increased
- Reports
- 133
- Reporting signal score
- 486.455
- Event
- weight increased
- Reports
- 322
- Reporting signal score
- 350.786
- NCT00042289
- NCT02771054
- NCT03656783
- NCT03727152
- NCT03858478
- NCT04039217
- NCT04054089
- NCT04066881
- NCT04222283
- NCT04530630
- NCT04542070
- NCT04653194
- NCT04944654
- NCT04993872
- NCT05405751
- NCT05549180
- NCT05592613
- NCT05602506
- NCT05648201
- NCT05663892
- NCT02957994
- NCT04496882
- NCT03696160
- NCT05813964
- NCT04040075
And 7 more, listed on the interactive page.
- Dose
- 25 mg TAF
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take with or without food
- Hydrogen bond acceptors
- 10
- Hydrogen bond donors
- 2
- Polar surface area
- 143.48
- Calculated partition coefficient (ALogP)
- 2.97
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 11
- Heavy atoms
- 74
- Molecular formula
- C46H62N12O14P2
- Monoisotopic mass
- 1068.39836869
- Natural product
- No
- 50090-6247
- 61958-1901
- 61958-2002
- 61958-2005
- 61958-2101
- 61958-2301
- 61958-2501
- 61958-2505
- 61958-2506
- Recorded assays
- 15
- Active assays
- 3
Active assay types
- Confirmatory
Related records
Trials (151)
- (mo)BETTA Trial in Transwomen for Optimization of ART
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
- A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)
- A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B
- A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
- A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
- A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
- A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
- A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
- A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain
- A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
- A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)
- A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
- A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
- A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection
- A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
- A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
- An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate
Approved for (3)
In development for (1)
- AIDS Phase 3