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Lamivudine (3TC)
Lamivudine (3TC) is a Nucleoside reverse transcriptase inhibitor (NRTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection (as part of combination antiretroviral therapy), HIV-2 infection (as part of combination antiretroviral therapy), Chronic hepatitis B infection. Also known as: 3TC, Epivir.
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks HIV reverse transcriptase, preventing viral RNA from being converted into DNA and integrated into host cells.
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks HIV reverse transcriptase, preventing viral RNA from being converted into DNA and integrated into host cells. Used for HIV-1 infection (as part of combination antiretroviral therapy), HIV-2 infection (as part of combination antiretroviral therapy), Chronic hepatitis B infection.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Lamivudine (3TC) |
|---|---|
| Also known as | 3TC, Epivir |
| Sponsor | ViiV Healthcare |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Lamivudine is a cytidine analog that gets phosphorylated intracellularly and incorporated into the growing DNA chain during reverse transcription, causing chain termination. By inhibiting reverse transcriptase, it prevents HIV replication and reduces viral load. It is commonly used as part of combination antiretroviral therapy (cART) for HIV-1 and HIV-2 infection.
Approved indications
- HIV-1 infection (as part of combination antiretroviral therapy)
- HIV-2 infection (as part of combination antiretroviral therapy)
- Chronic hepatitis B infection
Common side effects
- Headache
- Nausea
- Fatigue
- Diarrhea
- Abdominal pain
- Pancreatitis (rare)
- Lactic acidosis (rare)
Key clinical trials
- Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa (NA)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lamivudine (3TC) CI brief — competitive landscape report
- Lamivudine (3TC) updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about Lamivudine (3TC)
What is Lamivudine (3TC)?
How does Lamivudine (3TC) work?
What is Lamivudine (3TC) used for?
Who makes Lamivudine (3TC)?
Is Lamivudine (3TC) also known as anything else?
What drug class is Lamivudine (3TC) in?
What development phase is Lamivudine (3TC) in?
What are the side effects of Lamivudine (3TC)?
What does Lamivudine (3TC) target?
Related
- Drug class: All Nucleoside reverse transcriptase inhibitor (NRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection (as part of combination antiretroviral therapy)
- Indication: Drugs for HIV-2 infection (as part of combination antiretroviral therapy)
- Indication: Drugs for Chronic hepatitis B infection
- Also known as: 3TC, Epivir
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing