Drug

Lamivudine

Approved · EMA

Late-stage development

Also known as (-)-2'-Deoxy-3'-thiacytidine, 2',3'-Dideoxy-3'-thiacytidine, 3'-Thia-2',3'-dideoxycytidine, 3TC+19 more

(-)-2'-Deoxy-3'-thiacytidine, 2',3'-Dideoxy-3'-thiacytidine, 3'-Thia-2',3'-dideoxycytidine, 3TC, Cimduo, Combivir, Delstrigo, Dovato, Epivir, Epivir HBV, Epzicom, Symfi, Temixys, Triumeq, Trizivir, beta-L-2',3'-Dideoxy-3'-thiacytidine, beta-L-3'-Thia-2',3'-dideoxycytidine, Abacavir-Lamivudine, Lamivudine-Zidovudine, Lamivudin, Lamivudina, (-)-1-((2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine, Lamivudinum.

RxNorm68244 ChEMBLCHEMBL141UNII2T8Q726O95

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1b/2 Trial of Lamivudine in the Treatment of Relapsed/Refractory Solid Tumors Progression on Anti-PD-(L)1 Blockade

Clinical trial2026-07-28Primary completion · ClinicalTrials.gov

A Phase 1b, Multi-cohort Clinical Trial Assessing Safety and Feasibility of Exercise and Spermidine Administered in Conjunction With Lamivudine (RTi) or Rapamycin (mTORi) to Assess Impact on Dynamic Changes of Inflammation and Aging

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

Clinical trial2026-06-25Results expected Q2 2029 · ClinicalTrials.gov

Lamivudine in Individuals With Rett Syndrome: Clinical, Biochemical, and Cellular Evaluation

Clinical trial2026-06-10Results expected Q2 2027 · ClinicalTrials.gov

A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-04-15Primary completion · ClinicalTrials.gov

Antiviral Therapy in Infants With HBV Infection

Clinical trial2025-11-01Primary completion · ClinicalTrials.gov

A Single-center, Self-controlled, Prospective Case Series Pilot Study to Assess the Effect of Lamivudine (3TC) on Neurocognitive Impairment Biomarkers and Type-I IFN (Interferon)-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment (MCI)

Clinical trial2025-09-05Primary completion · ClinicalTrials.gov

Phase 3b, Single Arm, Single Site 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 Clinical Trial (NCT02284035)

Clinical trial2025-07-18Results posted · ClinicalTrials.gov

Approval: Lamivudine Teva Pharma B.V. (EMA)

Regulatory2009-12-10EMA

Approval: Lamivudine Teva (EMA)

Regulatory2009-10-23EMA

Approval: Zeffix (EMA)

Regulatory1999-07-29EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Lamivudine

Aliases & brands

(-)-2'-Deoxy-3'-thiacytidine2',3'-Dideoxy-3'-thiacytidine3'-Thia-2',3'-dideoxycytidine3TCCimduoCombivirDelstrigoDovatoEpivirEpivir HBVEpzicomSymfiTemixysTriumeqTrizivirbeta-L-2',3'-Dideoxy-3'-thiacytidinebeta-L-3'-Thia-2',3'-dideoxycytidineAbacavir-LamivudineLamivudine-ZidovudineLamivudinLamivudina(-)-1-((2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl)cytosineLamivudinum

RxNorm CUI

68244

ChEMBL ID

CHEMBL141

UNII

2T8Q726O95

Regulatory jurisdictions

ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

1999-07-29

Latest approval

2009-12-10

Authorities

EMA

Total events

emaEuropean Medicines Agency· 3 events

2009-12-10Approval

Approval: Lamivudine Teva Pharma B.V. (EMA)

Indication: Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

Evidence ↗

2009-10-23Approval

Approval: Lamivudine Teva (EMA)

Indication: Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated… Show full indication

Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).

Evidence ↗

1999-07-29Approval

Approval: Zeffix (EMA)

Indication: Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum… Show full indication

Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.