Ziagen

(Abacavir)

ApprovedSmall molecule

Abacavir is an antiretroviral medication used to treat HIV infection by reducing the amount of virus in the blood. While it doesn't cure HIV, it helps prevent the development of AIDS and HIV-related illnesses, and can reduce the risk of transmitting HIV to others.[2] Ziagen is currently approved and in use across 9 indications[4].[1]

Ziagen is one of 192 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

191

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

Malignant GliomaApproved

Kaposi's SarcomaApproved

LipodystrophyApproved

Lactic AcidosisApproved

HIV-1 InfectionApproved

High Grade GliomaRecruiting

Hepatitis BActive, not recruiting

HIV InfectionNot yet recruiting

Viral DiseaseApproved

Active, not recruiting

Malignant GliomaApproved

Approved

Kaposi's SarcomaApproved

Approved

LipodystrophyApproved

Approved

Lactic AcidosisApproved

Approved

HIV-1 InfectionApproved

Approved

High Grade GliomaPhase 1

Recruiting

Hepatitis BPreclinical

Active, not recruiting

HIV InfectionApproved

Not yet recruiting

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Videx

Bristol-Myers Squibb

Approved

14 2

Viramune

Boehringer Ingelheim

Approved

11 3

Ziagen

GSK

Approved

4 4

Arava

Mycobutin

Cabenuva

Golytely

Hepsera

Zofran

Viread

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

Phase 3Not yet recruiting

HIV Infection

NCT07792096

Q2 2030

Phase 1Recruiting

High Grade Glioma

NCT06428045

Clinical

Trials by Indication[1]

HIV5 trials

A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

Completed· GSK logo

GSK·Phase 3·NCT00046176·240 enrolled

Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00084149·54 enrolled

D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)

Completed·UUniversity of British Columbia·Phase 2/3·NCT00143702·80 enrolled

Show 2 more trials

Comparison of Abacavir Following Once-Daily And Twice-Daily Administration In HIV Infected Subjects

Completed· GSK logo

GSK·Phase 1·NCT00320307·30 enrolled

Abacavir Pharmacokinetic Study in the Absence/Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects

Completed·SSt Stephens Aids Trust·Phase 1·NCT00765271·29 enrolled

HIV infection4 trials

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Completed·KKirby Institute·Phase 4·NCT00192660·80 enrolled

Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00013520·1,125 enrolled

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT02384395·40 enrolled

Show 1 more trial

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa

Not yet recruiting·UUniversity College, London·Phase 3·NCT07792096·800 enrolled

Tenofovir3 trials

Phase II Comparator Study of Substitution of Tenofovir or Abacavir Receiving Thymidine Analogue as Part of HAART.

Completed· Gilead logo

Gilead·Phase 2·NCT00270556·100 enrolled

Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir

Completed·UUniversity of California, San Diego·Phase 2·NCT00214890·21 enrolled

Tenofovir Abacavir Platelet Activation Study

Completed·JJan Gerstoft·Phase 4·NCT02093585·43 enrolled

Effectiveness3 trials

Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Unknown status· GSK logo

GSK·Phase 4·NCT00011895·400 enrolled

A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults

Completed· GSK logo

GSK·Phase 4·NCT00004585·40 enrolled

Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

Unknown status· GSK logo

GSK·Phase 3·NCT00004981·230 enrolled

Children2 trials

Abacavir and Lamivudine PK in Children

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 2/3·NCT01656122·30 enrolled

When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00234091·300 enrolled

22 more indications

Adolescent2 trials

Blood Levels of Abacavir in HIV Infected Adolescents

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00087945·30 enrolled

A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00915655·12 enrolled

Interaction1 trial

Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine, Abacavir and Amprenavir in HIV-1 Infected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Naive Adults

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182765·8 enrolled

Tenofovir Disoproxil Fumarate1 trial

Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide

Unknown status·EErasmus Medical Center·Phase 4·NCT02957864·80 enrolled

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00799864·54 enrolled

Hepatitis B1 trial

Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00051090

Side Effects1 trial

Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00021463·342 enrolled

Immune1 trial

Increasing HAART-Induced Immune Restoration With Cyclosporine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00031070·40 enrolled

Child1 trial

Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00086359·19 enrolled

Drug1 trial

Once-Daily Drug Regimen for HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001968·25 enrolled

Itching1 trial

Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue

Completed· Gilead logo

Gilead·Phase 2·NCT00647946·100 enrolled

Treatment1 trial

Treatment Options for Protease Inhibitor-exposed Children

Completed·—·Phase 3·NCT01146873·300 enrolled

Solid Organ Transplant1 trial

Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 4·NCT03360682·19 enrolled

Aicardi-Goutières syndrome1 trial

Inhibition of Reverse Transcription in Aicardi-Goutières Syndrome

Completed·UUniversity of Edinburgh·Phase 2·NCT04731103·13 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients

Completed·—·Phase 4·NCT00647244·40 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Hypersensitivity1 trial

Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity

Completed· GSK logo

GSK·Phase 4·NCT00340080·1,806 enrolled

HIV-11 trial

New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

Completed· GSK logo

GSK·Phase 3·NCT00044577·166 enrolled

High Grade Glioma1 trial

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

Recruiting·UUniversity of Miami·Phase 1·NCT06428045·24 enrolled

Unspecified2 trials

Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

Completed·HHospital de Granollers·Phase 3·NCT00338390·75 enrolled

Determining the Effect of Abacavir on Platelet Activation

Completed·BBayside Health·Phase 4·NCT01886638·23 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 17, 1998

ZIAGEN

NDA NDA020978

Dec 17, 1998

ZIAGEN

NDA NDA020977

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Abacavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ziagen drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Abacavir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Abacavir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020978). U.S. Food & Drug Administration.
[6]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GSK

Ziagen

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2029

Q2 2030

Trials by Indication[1]

HIV5 trials

HIV infection4 trials

Tenofovir3 trials

Effectiveness3 trials

Children2 trials

Adolescent2 trials

Interaction1 trial

Tenofovir Disoproxil Fumarate1 trial

MPR1 trial

Combination Therapy1 trial

Tuberculosis1 trial

Immunodeficiency1 trial

Hepatitis B1 trial

Side Effects1 trial

Immune1 trial

Child1 trial

Drug1 trial

Itching1 trial

Treatment1 trial

Solid Organ Transplant1 trial

Aicardi-Goutières syndrome1 trial

Efficacy and Safety1 trial

Pregnancy1 trial

Hypersensitivity1 trial

HIV-11 trial

High Grade Glioma1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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