Emtriva

(Emtricitabine)

ApprovedSmall molecule

Emtricitabine is used to treat HIV infection by helping reduce the amount of HIV virus in the body. It is usually taken as part of a combination of medications to prevent HIV from getting worse.[2] Emtriva is currently approved and in use across 18 indications[4].[1]

Emtriva is one of 397 small molecule programs targeting AIDS. It is currently in Approved.

Indications

Total Trials

Active Trials

396

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AIDSApproved

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Hepatitis B Virus InfectionApproved

Bone DensityActive, not recruiting

Aicardi-Goutieres SyndromeApproved

HIV-1 InfectionActive, not recruiting

Chronic HepatitisActive, not recruiting

Chronic Hepatitis B Virus InfectionApproved

Primary Biliary CirrhosisApproved

AIDSApproved

Approved

HIV InfectionPhase 2

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Hepatitis B Virus InfectionApproved

Approved

Bone DensityPreclinical

Active, not recruiting

Aicardi-Goutieres SyndromeApproved

Approved

HIV-1 InfectionApproved

Active, not recruiting

Chronic HepatitisApproved

Active, not recruiting

Chronic Hepatitis B Virus InfectionApproved

Approved

Primary Biliary CirrhosisApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Emtriva

Gilead

Approved

49 2

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 3

Tricor

JJagotec

Preclinical

1 4

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 5

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 6

Statins

Sanofi

Preclinical

1 7

Statin

Bristol-Myers Squibb

Preclinical

1 8

Orap

Teva

Preclinical

1 9

Selenium

SSWOG Cancer Research Network

Preclinical

1 10

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

HIV

NCT05979311

Clinical

Trials by Indication[1]

Tenofovir5 trials

Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

Completed·AAbbott·Phase 3·NCT00043966·200 enrolled

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract

Completed·UUniversity of Minnesota··NCT03218085·28 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 2 more trials

Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00158457·40 enrolled

Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00334256·72 enrolled

Drug5 trials

A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00102206·6 enrolled

A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00036452·402 enrolled

A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

Unknown status·TTriangle Pharmaceuticals·Phase 3·NCT00006208

Show 2 more trials

Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

Completed·TTriangle Pharmaceuticals·Phase 3·NCT00002416·390 enrolled

A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Suspended·TTriangle Pharmaceuticals·Phase 3·NCT00002362

HIV infection4 trials

Study to Evaluate a HIV Drug for the Treatment of HIV Infection

Completed· GSK logo

GSK·Phase 2·NCT01803074·107 enrolled

Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Completed·SSEARCH Research Foundation·Phase 1/2·NCT02475915·15 enrolled

Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01505114·594 enrolled

Show 1 more trial

Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01040091·34 enrolled

Chronic Hepatitis3 trials

Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Unknown status·AAsian-Pacific Alliance of Liver Disease, Beijing·Phase 4·NCT02327676·200 enrolled

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Unknown status·AAsian-Pacific Alliance of Liver Disease, Beijing·Phase 4·NCT02327663·2,000 enrolled

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Unknown status·AAsian-Pacific Alliance of Liver Disease, Beijing·Phase 4·NCT02327702·200 enrolled

Tenofovir Disoproxil Fumarate2 trials

A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01709084·426 enrolled

Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

Completed· Gilead logo

Gilead·Phase 3·NCT00112047·517 enrolled

29 more indications

Effectiveness2 trials

The Safety and Effectiveness of 524W91

Completed· GSK logo

GSK·Phase 1·NCT00002335·18 enrolled

Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00016718·43 enrolled

Immunodeficiency1 trial

A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00799864·54 enrolled

Hepatitis B1 trial

Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

Completed·IInternational Antiviral Therapy Evaluation Center·Phase 4·NCT00127959·24 enrolled

Infants1 trial

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Completed·—··NCT04862975·164 enrolled

Prospective1 trial

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT00084136·1,571 enrolled

Cirrhosis1 trial

Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Unknown status·AAsian-Pacific Alliance of Liver Disease, Beijing·Phase 4·NCT02327689·400 enrolled

Prevention1 trial

Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients

Unknown status·AAsian-Pacific Alliance of Liver Disease, Beijing·Phase 4·NCT02327715·200 enrolled

Unknown status·TTriangle Pharmaceuticals·Phase 2·NCT00017992·100 enrolled

HIV Prevention1 trial

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

Completed·CCONRAD·Phase 1·NCT02904369·73 enrolled

Impaired Renal Function1 trial

Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT02116660·11 enrolled

Treatment1 trial

Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00051831·19 enrolled

Efficacy1 trial

The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

Completed·IImperial College London·Phase 4·NCT01335620·19 enrolled

Adult1 trial

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·N/A·NCT00608569·529 enrolled

Infection1 trial

Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 2·NCT00476463·24 enrolled

Medication1 trial

Three Month Course of Anti-HIV Medications for People Recently Infected With HIV

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00087464

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Pediatric1 trial

An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

Completed· Gilead logo

Gilead·Phase 2·NCT00642291·16 enrolled

Menstrual Cycle1 trial

Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00869960·24 enrolled

Bone1 trial

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01400412·262 enrolled

Pediatric Patients1 trial

Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine

Completed· Gilead logo

Gilead·Phase 2·NCT00743340·50 enrolled

ART1 trial

Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00380159·4 enrolled

Interaction1 trial

Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine

Completed· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 1·NCT04477096·36 enrolled

Women1 trial

NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00089505·745 enrolled

CLE1 trial

Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT03917420·10 enrolled

Solid Organ Transplant1 trial

Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 4·NCT03360682·19 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

Unspecified1 trial

Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study

Recruiting·NNational University Hospital, Singapore·Phase 1·NCT07210528·48 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 2, 2003

EMTRIVA

NDA NDA021500

Sep 28, 2005

EMTRIVA

NDA NDA021896

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Emtricitabine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Emtriva drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Emtricitabine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Emtricitabine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021896). 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

Emtriva

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Tenofovir5 trials

Drug5 trials

HIV infection4 trials

Chronic Hepatitis3 trials

Tenofovir Disoproxil Fumarate2 trials

Effectiveness2 trials

Immunodeficiency1 trial

Hepatitis B1 trial

Infants1 trial

Prospective1 trial

Cirrhosis1 trial

Prevention1 trial

Aging1 trial

Tuberculosis1 trial

Children1 trial

HIV Prevention1 trial

Impaired Renal Function1 trial

Treatment1 trial

Efficacy1 trial

Adult1 trial

Infection1 trial

Medication1 trial

Pregnancy1 trial

Pediatric1 trial

Menstrual Cycle1 trial

Bone1 trial

Pediatric Patients1 trial

ART1 trial

Interaction1 trial

Women1 trial

CLE1 trial

Solid Organ Transplant1 trial

HIV1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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