Lamivudine

Overview

A reverse transcriptase inhibitor and zalcitabine analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat Human Immunodeficiency Virus Type 1 (HIV-1) and hepatitis B (HBV).

Indication

For the treatment of HIV infection and chronic hepatitis B (HBV).

Associated Conditions

Chronic Hepatitis B Infection
Human Immunodeficiency Virus (HIV) Infections
Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation	2025/07/10	NCT07058974	Not Applicable	Not yet recruiting	Icahn School of Medicine at Mount Sinai
A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)	2025/02/06	NCT06811246	Phase 1	Completed	Merck Sharp & Dohme LLC
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)	2024/07/25	NCT06519357	Phase 2	Active, not recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Antiviral Therapy in Infants With HBV Infection	2024/07/16	NCT06503796	Phase 4	Not yet recruiting	Beijing 302 Hospital
Lamivudine for Solid Tumors	2024/07/10	NCT06494579	Phase 1	Recruiting	Thomas Marron
STARLITE for Unresectable High-Grade Gliomas	2024/05/24	NCT06428045	Phase 1	Recruiting	University of Miami
Lamivudine and Plasma Markers of Inflammation in Retinal Detachment	2023/09/28	NCT06056596	Early Phase 1	Recruiting	University of Wisconsin, Madison
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	2023/08/07	NCT05979311	Phase 3	Active, not recruiting	ViiV Healthcare
A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients	2022/04/18	NCT05332470	N/A	Not yet recruiting	Peking Union Medical College Hospital
Triumeq in Amyotrophic Lateral Sclerosis	2022/01/18	NCT05193994	Phase 3	Terminated	Macquarie University, Australia

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
COMBIVIR	ViiV Healthcare Company	49702-202	ORAL	150 mg in 1 1	4/27/2018
Triumeq	ViiV Healthcare Company	49702-231	ORAL	300 mg in 1 1	6/15/2023
Lamivudine and Zidovudine	Macleods Pharmaceuticals Limited	33342-003	ORAL	150 mg in 1 1	7/13/2023
Lamivudine and Zidovudine	Aurobindo Pharma Limited	65862-036	ORAL	150 mg in 1 1	5/11/2022
Abacavir and lamivudine	Zydus Pharmaceuticals USA Inc.	70710-1049	ORAL	300 mg in 1 1	5/15/2023
LAMIVUDINE	State of Florida DOH Central Pharmacy	53808-0844	ORAL	300 mg in 1 1	9/12/2013
Lamivudine	Aurobindo Pharma Limited	65862-055	ORAL	10 mg in 1 mL	12/8/2021
Lamivudine and Zidovudine	Rebel Distributors Corp	21695-996	ORAL	150 mg in 1 1	4/26/2010
SYMFI LO	Mylan Specialty L.P.	49502-425	ORAL	300 mg in 1 1	9/9/2019
LAMIVUDINE and ZIDOVUDINE	NuCare Pharmaceuticals,Inc.	68071-4450	ORAL	150 mg in 1 1	1/14/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Triumeq	ViiV Healthcare B.V.,Van Asch van Wijckstraat 55 H,3811 LP Amersfoort,The Netherlands	Authorised	8/31/2014
Combivir	ViiV Healthcare BV,Van Asch van Wijckstraat 55H,3811 LP Amersfoort,The Netherlands	Authorised	3/18/1998
Trizivir	ViiV Healthcare BV,Van Asch van Wijckstraat 55H,3811 LP Amersfoort,The Netherlands	Authorised	12/27/2000
Dovato	ViiV Healthcare B.V.,Van Asch van Wijckstraat 55 H,3811 LP Amersfoort,The Netherlands	Authorised	6/10/2022
Delstrigo	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	11/22/2018
Kivexa	ViiV Healthcare BV,Van Asch van Wijckstraat 55H,3811 LP Amersfoort,The Netherlands	Authorised	12/16/2004
Lamivudine Teva Pharma B.V.	Teva B.V.,Teva B.V.,Swensweg 5,2031 GA Haarlem,The Netherlands	Authorised	12/10/2009
Lamivudine Teva	Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands	Authorised	10/23/2009
Zeffix	GlaxoSmithKline (Ireland) Limited,12 Riverwalk,Citywest Business Campus,Dublin 24,Ireland	Authorised	7/29/1999
Epivir	ViiV Healthcare BV,Van Asch van Wijckstraat 55H,3811 LP Amersfoort,The Netherlands	Authorised	8/8/1996

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DOVATO FILM-COATED TABLET 50MG/300MG	GlaxoSmithKline LLC, Glaxo Wellcome S.A.	SIN15989P	TABLET, FILM COATED	300 mg	8/13/2020
EPIVIR TABLET 150 mg	GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS), Delpharm Poznan S.A.	SIN09134P	TABLET, FILM COATED	150 mg	1/11/1997
EPIVIR ORAL SOLUTION 10 mg/ml	GLAXO WELLCOME OPERATIONS, Bora Pharmaceutical Services Inc.	SIN09135P	SOLUTION	10 mg/ml	1/11/1997
LAVUDIN STANDARD F.C. TABLET 100 mg	Standard Chem. & Pharm. Co. Ltd	SIN15204P	TABLET, FILM COATED	100 mg	3/31/2017
ZEFFIX TABLETS 100 mg	Glaxo Wellcome Operations, GlaxoSmithKline Australia Pty Ltd (primary and secondary packager), Delpharm Poznań S.A.	SIN11152P	TABLET, FILM COATED	100 mg	10/6/1999
ABALAM ABACAVIR SULFATE & LAMIVUDINE TABLETS 600/300 MG	HETERO LABS LIMITED	SIN15864P	TABLET, FILM COATED	300.000 mg	12/2/2019
COMBIVIR TABLETS	Glaxo Operations UK Ltd (Trading as Glaxo Wellcome Operations), Delpharm Poznan S.A.	SIN10795P	TABLET, FILM COATED	150 mg	3/9/1999
Kivexa	Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), GlaxoSmithKline Australia Pty Ltd (primary and secondary packager), Delpharm Poznań S.A., Glaxo Wellcome S.A (primary and secondary packager)	SIN13230P	TABLET	300 mg	1/11/2007
DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG	PT Organon Pharma Indonesia Tbk (Primary and secondary packager), MSD International GmbH T/A MSD Ireland (Ballydine), Hovione FarmaCiencia S.A. (DP Intermediate)	SIN15909P	TABLET, FILM COATED	300mg	3/13/2020
TRIUMEQ FILM COATED TABLET 50mg/600mg/300mg	Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Glaxo Wellcome, S.A. (Primary and Secondary Packager), Delpharm Poznań S.A.	SIN15100P	TABLET, FILM COATED	300 mg	10/14/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Lamivudine Capsules	北京福元医药股份有限公司	国药准字H20110078	化学药品	胶囊剂	4/15/2021
Lamivudine Oral Solution	红云制药（成都）有限公司	国药准字H20244243	化学药品	口服溶液剂	6/28/2024
Lamivudine Oral Solution	陕西汉唐制药有限公司	国药准字H20133135	化学药品	口服溶液剂	4/23/2023
Lamivudine Oral Solution	江苏汉晨药业有限公司	国药准字H20183379	化学药品	口服溶液剂	5/5/2023
Lamivudine Oral Solution	陕西汉唐制药有限公司	国药准字H20183112	化学药品	口服溶液剂	4/23/2023
Lamivudine Tablets	安徽省先锋制药有限公司	国药准字H20143363	化学药品	片剂	2/21/2020
Lamivudine Tablets	长春海悦药业股份有限公司	国药准字H20223519	化学药品	片剂	7/12/2022
Lamivudine Tablets	中孚药业股份有限公司	国药准字H20133057	化学药品	片剂	11/3/2021
Lamivudine Tablets	陕西汉唐制药有限公司	国药准字H20153123	化学药品	片剂	8/3/2020
Lamivudine Tablets	湖南千金湘江药业股份有限公司	国药准字H20103481	化学药品	片剂	7/29/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
3TC ORAL SOLUTION 10MG/ML	N/A	葛兰素史克	N/A	N/A	5/21/1997
DOVATO TABLETS	N/A	葛兰素史克	N/A	N/A	12/31/2019
LAVIDINE TABLETS 100MG	N/A	FLOURISHING MEDICINE COMPANY LIMITED	N/A	N/A	3/14/2017
TRIUMEQ TABLETS	N/A	葛兰素史克	N/A	N/A	10/6/2015
ZEFFIX TABLETS 100MG	N/A	葛兰素史克	N/A	N/A	10/6/2015
KIVEXA TAB	N/A	葛兰素史克	N/A	N/A	12/10/2005
COMBIVIR TABLETS	N/A	葛兰素史克	N/A	N/A	4/29/2015
3TC TABLETS 150MG	N/A	葛兰素史克	N/A	N/A	11/1/2016

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
LAMIVUDINE RANBAXY	172816	Sun Pharma ANZ Pty Ltd	Medicine	A	10/25/2011
TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300 mg tablet bottle	218644	ViiV Healthcare Pty Ltd	Medicine	A	1/14/2015
CAVADEXA 600/300 Abacavir (as sulfate) and Lamivudine 600mg/300mg tablets, PVC/PVdC-Alu blister pack	297931	Hetero Australia Pty Ltd	Medicine	A	12/13/2022
LARANDINE lamivudine 100 mg tablets bottle	206863	Sun Pharma ANZ Pty Ltd	Medicine	A	5/28/2014
GenRx ABACAVIR/LAMIVUDINE 600/300 abacavir 600mg (as sulfate) and lamivudine 300mg tablets bottle	239752	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/3/2016
CAVADEXA 600/300 Abacavir (as sulfate) and Lamivudine 600mg/300mg tablets, Alu-Alu blister pack	297920	Hetero Australia Pty Ltd	Medicine	A	12/13/2022
LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 lamivudine 150 mg / zidovudine 300 mg film-coated tablet bottle	167477	Alphapharm Pty Ltd	Medicine	A	10/3/2012
LAMIVUDINE VIATRIS lamivudine 300 mg film-coated tablet bottle	167594	Alphapharm Pty Ltd	Medicine	A	2/16/2012
ABADINE 600/300 Abacavir (as sulfate) and Lamivudine 600mg/300mg tablets, HDPE bottle pack	297932	Hetero Australia Pty Ltd	Medicine	A	12/13/2022
3TC lamivudine 10mg/mL oral liquid solution bottle	64346	ViiV Healthcare Pty Ltd	Medicine	A	6/9/1998

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