> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/tenofovir-alafenamide-fumarate-9adf6f5f-c34a-4fdb-9c9f-210ec050ca0b > Record changed: 2026-10-13 # Tenofovir alafenamide fumarate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) First approval year 2015 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) ## Development status **First approval year** 2015 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) **Drug name** Tenofovir alafenamide fumarate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) **Molecular weight** 1,069.02 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) **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 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) ### Brand names (12) - 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 ### Other names (38) - 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. ## Identifiers **CAS registry numbers** - 1392275-56-7 **ChEMBL ID** CHEMBL2364637 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) **InChIKey** SVUJNSGGPUCLQZ-FQQAACOVSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364637) **PubChem compound IDs** - 71492247 **RxNorm IDs (RxCUI)** - 1721604 **FDA ingredient codes (UNII)** - FWF6Q91TZO ## Regulatory information ### United States **Applicant** GILEAD SCIENCES INC **Approval date** 5 Nov 2015 **Application number** NDA207561 ### Other regulatory facts **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 ## Pharmacology ### Drug classification **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 ### Investigated indications (6) - **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 ### Open Targets indications (12) - **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 ### Reported adverse events (11) - **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 ### Trial references (32) - NCT00042289 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00042289) - NCT02771054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02771054) - NCT03656783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03656783) - NCT03727152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03727152) - NCT03858478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03858478) - NCT04039217 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04039217) - NCT04054089 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04054089) - NCT04066881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04066881) - NCT04222283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04222283) - NCT04530630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04530630) - NCT04542070 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04542070) - NCT04653194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04653194) - NCT04944654 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04944654) - NCT04993872 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04993872) - NCT05405751 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05405751) - NCT05549180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05549180) - NCT05592613 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05592613) - NCT05602506 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602506) - NCT05648201 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05648201) - NCT05663892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05663892) - NCT02957994 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02957994) - NCT04496882 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04496882) - NCT03696160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03696160) - NCT05813964 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05813964) - NCT04040075 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04040075) And 7 more, listed on the interactive page. ## Dosing **Dose** 25 mg TAF **Route** Oral **How often** Once daily ### Conditions of use - Take with or without food ## Chemical properties **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 ## National Drug Codes - 50090-6247 - 61958-1901 - 61958-2002 - 61958-2005 - 61958-2101 - 61958-2301 - 61958-2501 - 61958-2505 - 61958-2506 ## Evidence counts **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) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) - [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) ### In development for (1) - AIDS Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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