Vemlidy

(Tenofovir Alafenamide)

ApprovedSmall molecule

Tenofovir Alafenamide is used to treat HIV infection and chronic hepatitis B by helping to reduce the amount of virus in the blood.[2] Vemlidy is currently approved and in use across 19 indications[4].[1]

Vemlidy is one of 513 small molecule programs targeting Hepatitis B. It is currently in Approved.

Indications

Total Trials

Active Trials

512

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Hepatitis BNot yet recruiting

Liver TransplantUnknown status

Body Weight GainApproved

Chronic HepatitisUnknown status

AIDSApproved

HIV-1 InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Elevated Circulating Hepatic Transaminase ConcentrationActive, not recruiting

Acute-on-Chronic Liver FailureActive, not recruiting

TuberculosisActive, not recruiting

Hepatitis BApproved

Not yet recruiting

Liver TransplantApproved

Unknown status

Body Weight GainApproved

Approved

Chronic HepatitisApproved

Unknown status

AIDSApproved

Approved

HIV-1 InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Elevated Circulating Hepatic Transaminase ConcentrationApproved

Active, not recruiting

Acute-on-Chronic Liver FailurePreclinical

Active, not recruiting

TuberculosisPreclinical

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Vemlidy

Gilead

Approved

1 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Lorelco

Sanofi

Preclinical

1 6

Activase

Flomax

PROCRIT

1 9

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 10

Januvia

ZZydus Therapeutics Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Chronic Kidney Disease

NCT05423834

Q1 2027

Phase 3Active, not recruiting

HIV

NCT05979311

Q3 2027

N/ARecruiting

Treatment

NCT04231565

Post-ApprovalActive, not recruiting

Liver Transplant

NCT05410496

Q4 2027

N/ARecruiting

Liver Disease

NCT05195450

Clinical

Trials by Indication[1]

Chronic Hepatitis16 trials

The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury.

Unknown status·NNational Cheng-Kung University Hospital·Phase 4·NCT04674423·40 enrolled

A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

Active, not recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06150014·88 enrolled

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT04195074·300 enrolled

Show 13 more trials

An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05275023·37 enrolled

Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

Unknown status·UUniversity Health Network, Toronto·Phase 4·NCT04070079·15 enrolled

Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.

Completed·YYoung-Suk Lim·Phase 4·NCT03241641·174 enrolled

Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance

Unknown status·YYonsei University··NCT03566030·300 enrolled

Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B

Completed·NNucorion Pharmaceuticals, Inc.·Phase 1·NCT04629976·21 enrolled

A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

Completed·SShanghai HEP Pharmaceutical Co., Ltd.·Phase 2·NCT05244057·8 enrolled

Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

Recruiting·TTaichung Veterans General Hospital··NCT05583006·60 enrolled

Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 1·NCT04507607·50 enrolled

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Completed· Gilead logo

Gilead·Phase 2·NCT04891770·103 enrolled

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Recruiting·TTaichung Veterans General Hospital·Phase 4·NCT03933384·140 enrolled

Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Unknown status· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 4·NCT03604016·76 enrolled

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04439539·54 enrolled

Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

Completed·SStanford University·Phase 4·NCT03471624·270 enrolled

Hepatitis B7 trials

Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus

Unknown status·SSoutheast University, China··NCT04065230·330 enrolled

Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B

Unknown status·TThe First Affiliated Hospital of Zhengzhou University·Phase 4·NCT04850950·240 enrolled

TAF Switch Study in Hepatitis B Monoinfection

Unknown status·AAsian Pacific Liver Center at Coalition of Inclusive Medicine·Phase 4·NCT02957994·82 enrolled

Show 4 more trials

Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus

Terminated·FF-star Therapeutics, Inc.·Phase 2·NCT04059198·5 enrolled

Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03695029·120 enrolled

Strengthening Hepatitis B Screening, Linkage to Care and Long-Term Monitoring in Phichit Province, Thailand: A Birth Bohort Approach

Not yet recruiting·TThe Task Force for Global Health·Phase 4·NCT07258251·6,000 enrolled

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT04196998·150 enrolled

Efficacy and Safety5 trials

The Efficacy and Safety of TAF vs Other NAs in Patients With LVL

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT04501224·200 enrolled

Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea

Unknown status·TThe Catholic University of Korea··NCT03559790·400 enrolled

Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients

Unknown status·HHuashan Hospital··NCT04864366·150 enrolled

Show 2 more trials

Efficacy and Safety of TAF in Patients With Suboptimal Response to Other Nucleos(t)Ides

Unknown status·NNew Discovery LLC·Phase 4·NCT04201808·100 enrolled

A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir

Unknown status·TThe First Hospital of Jilin University·Phase 4·NCT04034368·8 enrolled

Tenofovir4 trials

Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT03510468·51 enrolled

Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06592300·42 enrolled

Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02984852·30 enrolled

Show 1 more trial

Tenofovir Alafenamide in HBV Related Decompensated Liver

Unknown status·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 4·NCT04683341·100 enrolled

Treatment3 trials

Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

Recruiting·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT04231565·200 enrolled

Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

Recruiting·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT03920618·150 enrolled

A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients

Completed· Gilead logo

Gilead·Phase 1/2·NCT00036634·30 enrolled

33 more indications

Chronic Hepatitis B Virus Infection3 trials

A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04129554·130 enrolled

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04585789·24 enrolled

A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04667104·48 enrolled

Liver Transplant3 trials

Tenofovir Alafenamide for HBV Prophylaxis in HBV(-) Liver Transplant Recipients With HBcAb+ Donors

Unknown status·RRenJi Hospital·N/A·NCT04703465·30 enrolled

Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients with Chronic HBV Infection

Active, not recruiting·TTaichung Veterans General Hospital·Phase 4·NCT05410496·52 enrolled

Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

Unknown status·FFudan University·Phase 4·NCT05063071·150 enrolled

Function2 trials

TAF for HIV-HBV With Renal Dysfunction

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 2·NCT03115736·24 enrolled

Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF

Completed·HHumanity and Health Research Centre·Phase 4·NCT03356834·575 enrolled

Effectiveness2 trials

TAF Real World Study for Universal Effectiveness

Unknown status·TTongji Hospital··NCT03752658·500 enrolled

Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines

Active, not recruiting·YYoung-Suk Lim·Phase 4·NCT03753074·780 enrolled

Acute-on-Chronic Liver Failure2 trials

The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Completed·XXiangya Hospital of Central South University·N/A·NCT05453448·272 enrolled

The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University··NCT03640728·200 enrolled

Chronic Hepatitis b2 trials

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial With an Open-Label Extension to Evaluate the Efficacy and Safety of TQA3605 Tablets in Chronic Hepatitis B Virus-Infected Patients With Low-Level Viremia or Suboptimal Response After at Least 12 Months of NAs Therapy

Not yet recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT07797231·930 enrolled

A Single-Center, Open-Label, Single-Arm, Self-Controlled Phase I Clinical Study to Evaluate Drug-Drug Interactions of Hydronidone With Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide in Healthy Chinese Subjects

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07295873·64 enrolled

HIV Prevention1 trial

PK and PD Study of Oral F/TAF for HIV Prevention

Completed·CCONRAD·Phase 1·NCT02904369·73 enrolled

Multiple Sclerosis1 trial

Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT04880577

Terminated·SSWOG Cancer Research Network·Phase 3·NCT03887702·4 enrolled

Efficacy1 trial

The Efficacy of Prophylactic TAF for HBsAg-positive Patients Receiving bDMARDs

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT05001672·108 enrolled

Tenofovir Disoproxil Fumarate1 trial

Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide

Unknown status·EErasmus Medical Center·Phase 4·NCT02957864·80 enrolled

Cancer1 trial

TAF to Prevent HBV Reactivation in Cancer Patients

Active, not recruiting·—·Phase 4·NCT04619082·102 enrolled

Diffuse Large B-Cell Lymphoma1 trial

The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide

Terminated·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT03804372·5 enrolled

Infection1 trial

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT05467553·30 enrolled

First-line1 trial

ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy

Completed·PProfessor Francois Venter·Phase 3·NCT03122262·1,110 enrolled

Itching1 trial

Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen

Completed·TThomas Jefferson University··NCT03646370·110 enrolled

Tuberculosis1 trial

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04518228·205 enrolled

Chronic HBV Infection1 trial

Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Vertical Transmission

Unknown status·NNew Discovery LLC··NCT04237376·600 enrolled

Amyotrophic Lateral Sclerosis1 trial

HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT02437110·122 enrolled

Cirrhosis1 trial

The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China

Unknown status·PPeking University First Hospital·Phase 4·NCT04997564·120 enrolled

Pregnant Women1 trial

Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

Recruiting·FFirst People's Hospital of Hangzhou·Phase 4·NCT05853718·50 enrolled

Fibrosis1 trial

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

Unknown status·JJidong Jia·Phase 4·NCT04939441·100 enrolled

Women1 trial

PK of TAF and TDF for PrEP in Pregnant and Postpartum Women

Completed·UUniversity of California, Los Angeles·Phase 3·NCT04937881·39 enrolled

Chronic Kidney Disease1 trial

Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Active, not recruiting·—··NCT05423834·1,800 enrolled

Weight Gain1 trial

Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05652478·120 enrolled

HIV infection1 trial

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa

Not yet recruiting·UUniversity College, London·Phase 3·NCT07792096·800 enrolled

Hepatitis D, Chronic1 trial

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04535544·52 enrolled

HIV1 trial

A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV

Active, not recruiting· GSK logo

GSK·Phase 3·NCT05979311·307 enrolled

Hepatitis1 trial

An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study

Active, not recruiting·UUniversity of Maryland, Baltimore··NCT02995252·550 enrolled

Unspecified2 trials

Entecavir to TAF Switch

Active, not recruiting·TThomas Jefferson University·Phase 3·NCT03489239·27 enrolled

A Single and Multiple Ascending Dose Study of JNJ-64457744

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05423106·60 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 10, 2016

VEMLIDY

NDA NDA208464

Sources

References

[1]
ClinicalTrials.gov — 77 trial records for Tenofovir Alafenamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vemlidy drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tenofovir Alafenamide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tenofovir Alafenamide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208464). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Vemlidy

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Chronic Hepatitis16 trials

Hepatitis B7 trials

Efficacy and Safety5 trials

Tenofovir4 trials

Treatment3 trials

Chronic Hepatitis B Virus Infection3 trials

Liver Transplant3 trials

Function2 trials

Effectiveness2 trials

Acute-on-Chronic Liver Failure2 trials

Chronic Hepatitis b2 trials

HIV Prevention1 trial

Multiple Sclerosis1 trial

Pregnancy1 trial

Liver Disease1 trial

Partial Response1 trial

Hepatitis B Virus Infection1 trial

Efficacy1 trial

Tenofovir Disoproxil Fumarate1 trial

Cancer1 trial

Diffuse Large B-Cell Lymphoma1 trial

Infection1 trial

First-line1 trial

Itching1 trial

Tuberculosis1 trial

Chronic HBV Infection1 trial

Amyotrophic Lateral Sclerosis1 trial

Cirrhosis1 trial

Pregnant Women1 trial

Fibrosis1 trial

Women1 trial

Chronic Kidney Disease1 trial

Weight Gain1 trial

HIV infection1 trial

Hepatitis D, Chronic1 trial

HIV1 trial

Hepatitis1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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