Data updated: May 26, 2026
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (lamivudine)
Infectious Disease
Approved 2018-05-15
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2018-05-15
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Website: ↗
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2018 to 2018
What LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02369406 EIT | U01AI114235 | Ph 2, Ph 3 | active not recruiting | Early Infant HIV Treatment in Botswana |
| NCT06494579 | STUDY-24-00614 | Ph 1, Ph 2 | active not recruiting | Lamivudine for Solid Tumors |
| NCT04696575 | I 691720 NCI-2020-13169, I 691720 | Ph 2 | recruiting | Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer |
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT07058974 | STUDY-24-01678 | Ph 1 | recruiting | A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation |
| NCT02470650 | Cost-Effect-Clinic 2014-004820-24 | Ph 4 | withdrawn | Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive |
| NCT03311945 results posted | RALAM-Roll Over 2017-000986-60 | Ph 3 | completed | Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM |
| NCT06428045 STARLITE | 20231163 | Ph 1 | recruiting | STARLITE for Unresectable High-Grade Gliomas |
| NCT03333083 | RALAM-II 2017-000985-31 | Ph 3 | terminated | Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen |
| NCT06503796 | KY-2023-12-85-1 | Ph 4 | not yet recruiting | Antiviral Therapy in Infants With HBV Infection |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | 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 |
| NCT03144804 results posted | 17-044 | Ph 2 | completed | A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer |
| NCT01620944 results posted | AI424-494 2011-006187-47 | Ph 3 | terminated | Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC |
| NCT03272347 results posted | 8591-011 2017-000437-32 | Ph 2 | completed | Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) |
| NCT02712801 | 2015ZX10001001 | Ph 4 | completed | Antiretroviral Regime for Viral Eradication in Newborns |
| NCT00672412 | P1069 10620, IMPAACT P1069 | Ph 1, Ph 2 | completed | Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand |
| NCT02369965 TALENT | FB-ABWT-Ⅲ-301 ChiCTR-TRC-14004276 | Ph 3 | completed | Test Albuvirtide in Experienced Patients |
| NCT01352715 SELECT results posted | ACTG A5273 1U01AI068636, 5UM1AI068634 | Ph 3 | completed | Study of Options for Second-Line Effective Combination Therapy (SELECT) |
| NCT02566707 PRADAII | UMCN-AKF 14.08 | Ph 2 | terminated | Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen |
| NCT02263079 results posted | NV25361 2006-000977-31 | Ph 3 | completed | A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase |
| NCT02431975 LEOPARD | AAAO5011 U01HD080441 | Ph 4 | completed | Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial |
| NCT02945163 | 2016-M-2 | Ph 4 | completed | Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy |
| NCT02935075 OAT | 2016-M-1 | Ph 4 | completed | Optimization of Antiretroviral Therapy |
| NCT02263326 ASPIRE results posted | ASPIRE | Ph 3 | completed | Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure |
| NCT00993031 PROMOTE-PIs results posted | H5741-34342 P01HD059454, 2009-141 | Ph 3 | completed | Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | 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) |
| NCT03078556 results posted | 204994 | Ph 1 | completed | Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine |
| NCT02770508 ANDES | FH-15 | Ph 4 | completed | Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects |
| NCT02582684 results posted | ACTG A5353 2UM1AI068636 | Ph 2 | completed | Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients |
| NCT01353742 | 114957 | Ph 1 | completed | Lamivudine and Adefovir Dipivoxil Fixed Dose Combination |
| NCT01580202 | AI463-246 | Ph 3 | completed | Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine |
| NCT02634073 results posted | 204857 | Ph 4 | completed | A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers |
| NCT02159599 DUAL | GESIDA 8014 2014-000515-14 | Ph 4 | completed | Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject |
| NCT01627223 NUC115132 | NUC115132 | Ph 4 | terminated | Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation |
| NCT02894554 | 201310070MINA | Ph 4 | terminated | Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment. |
| NCT01489046 | AI467-003 2011-003329-89 | Ph 2 | terminated | Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive |
| NCT01528865 | UMCC 2010 097 HUM 33361 | Ph 1, Ph 2 | withdrawn | Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in Lymphoma |
| NCT00986778 | AI463-195 | Ph 4 | withdrawn | Entecavir Plus Adefovir in Lamivudine-Resistant Patients |
| NCT01005238 SASL28 | SASL28 | Ph 4 | terminated | Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine |
| NCT00637663 | 0740-67-5 | Ph 4 | completed | Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA |
| NCT01023217 CAESAR results posted | AMC-2009-0536 | Ph 4 | completed | Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir |
| NCT00410202 DEFINE results posted | AI463-111 | Ph 3 | completed | Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus |
| NCT01088009 EXPLORE | MOH-02 | Ph 4 | completed | Efficacy Optimizing Research of Lamivudine Therapy |
| NCT01743079 | 20080810 | Ph 4 | completed | Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B |
| NCT01788371 | 2011.6 | Ph 4 | completed | Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus |
| NCT00915655 DIONE results posted | CR016312 TMC114-TiDP29-C230, 2008-004631-37 | Ph 2 | completed | A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents |
| NCT00625339 | 4-2007-0367 | Ph 4 | completed | Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA |
| NCT00625560 | 4-2007-0351 | Ph 4 | completed | Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA |
| NCT00612898 | AVX-301 | Ph 2, Ph 3 | terminated | Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection |
| NCT00798460 | IB-0809-055 | Ph 4 | terminated | Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.