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Data updated: May 26, 2026

LAMIVUDINE AND ZIDOVUDINE (lamivudine)

Infectious Disease Approved 2011-05-25
Jump to: Indications Approvals Trials Competitors Safety Patents
12
Indications
--
Phase 3 Trials
1
Priority Reviews
15
Years on Market

Details

Status
Discontinued
First Approved
2011-05-25
Routes
ORAL
Dosage Forms
TABLET

Companies

PHARMOBEDIENT Cipla Aurobindo Pharma HETERO LABS LTD III EPIC PHARMA LLC MACLEODS PHARMS LTD PHARMACARE CHARTWELL RX Lupin HETERO LABS LTD V NATCO
Active Ingredient: LAMIVUDINE , ZIDOVUDINE

LAMIVUDINE AND ZIDOVUDINE Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
43 FDA actions from 2011 to 2024
Sep 2024 SUPPL
Label · Labeling
Apr 2023 SUPPL
Label · Labeling
Apr 2023 SUPPL
Label · Labeling

What LAMIVUDINE AND ZIDOVUDINE Treats

12 FDA approvals

Originally approved for its first indication in 2011 . Covers 12 distinct patient populations.

  • Other (12)
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Clinical Trial Registry

58 trials
Trial Sponsor ID Phase Status Title
NCT01419561 110220 11-C-0220 Ph 2 recruiting Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
NCT02737046 results posted 20150567 Ph 2 completed Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
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NCT02470650 Cost-Effect-Clinic 2014-004820-24 Ph 4 withdrawn Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive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
NCT03088410 IRB 2019-2922 R01DK109881, HRDC 00781 Ph 4 completed Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana
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
NCT01441063 results posted 110233 11-C-0233 Ph 2 completed Tocilizumab for KSHV-Associated Multicentric Castleman Disease
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
NCT01964755 results posted 20090166 Ph 2 terminated Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma
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
NCT01516970 PEPDar results posted CR018349 TMC114IFD3004, 2011-001303-13 Ph 3 completed Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
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
NCT00409591 PHPT-5 PHPT-5 First Phase R01HD052461, R01HD056953 Ph 3 terminated Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand
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
NCT01694017 10465 Ph 4 completed Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
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

Showing 50 of 58 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 ZIDOVUDINE FDA Label Details

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Data Sources

FDA Approval: ANDA079079 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.