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Drug

Abacavir

Approved · EMA
Emerging researchLate-stage development
Also known as ABC, Epzicom, Triumeq, Trizivir+3 more

ABC, Epzicom, Triumeq, Trizivir, Ziagen, Abacavir-Lamivudine, Abacavir Sulfate.

RxNorm190521ChEMBLCHEMBL1380UNIIWR2TIP26VS
1
Research papers
1
Active clinical trials
2
Regulatory events
Latest activity
beta

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

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

Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients

Clinical trial2025-09-30Results posted · ClinicalTrials.gov

A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged >= 6 to <18 Years

Clinical trial2024-06-25Results posted · ClinicalTrials.gov

Inhibition of Reverse Transcription in Type I Interferon Mediated Neuropathology

Clinical trial2024-03-11Completed · ClinicalTrials.gov

IGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect

Clinical trial2021-11-22Results posted · ClinicalTrials.gov

A Phase III, Randomized, Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting

Clinical trial2021-11-02Results posted · ClinicalTrials.gov

A Phase I/II Study of the Safety, Tolerability, and Antiretroviral Activity of Mycophenolate Mofetil As an Adjunct to Abacavir Therapy in HIV-Infected Subjects With Treatment Failure and Extensive Prior Antiretroviral Exposure

Clinical trial2021-11-01Withdrawn · ClinicalTrials.gov

Multicenter, Pilot Study of Telbivudine (LdT) Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected With HBV and HIV

Clinical trial2021-11-01Withdrawn · ClinicalTrials.gov

CCTG584: Viral Dynamics and Pharmacokinetics of Tenofovir and Abacavir Monotherapy Versus the Combination Therapy of TDF-ABC in HIV-Infected Treatment Naive Patients

Clinical trial2021-09-24Results posted · ClinicalTrials.gov

Drug Safety Update: Abacavir: risk of myocardial infarction—update from epidemiological studies

Regulatory2014-12-11MHRA

Abacavir and tenofovir disoproxil fumarate co-administration results in a nonadditive antiviral effect in HIV-1-infected patients.

Research2010-03-01AIDS (London, England)

Approval: Ziagen (EMA)

Regulatory1999-07-08EMA

Profile

Identifiers & mechanism

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

Canonical name
Abacavir
Aliases & brands
ABCEpzicomTriumeqTrizivirZiagenAbacavir-LamivudineAbacavir Sulfate
RxNorm CUI
190521
ChEMBL ID
CHEMBL1380
UNII
WR2TIP26VS
Regulatory jurisdictions
mhraema

Regulatory timeline

2 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
1999-07-08
Latest approval
1999-07-08
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
1999-07-08Approval
Approval: Ziagen (EMA)
Indication: Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration… Show full indication

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Abacavir: risk of myocardial infarction—update from epidemiological studies
Evidence ↗

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

89 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
89
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
50
Late-stage (III+)
78
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 89
Phase 114Phase 225Phase 2 / 32Phase 321Phase 412Phase N / A15

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Switching to Tenofovir Alafenamide Fumarate or Abacavir in Patients With Tenofovir Disoproxil Fumarate Associated eGFR Decline. A Randomized Trial.

Unknown statusPH IVErasmus Medical Centern=802020

Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients

CompletedPH IVFundacion Clinic per a la Recerca Biomédican=192020

Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens

CompletedPH IVJan Gerstoftn=432017

Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study

CompletedPH IVBayside Healthn=232014

Efficacy and Safety of Switching From AZT to Tenofovir

CompletedPH IVAarhus University Hospitaln=402010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Inhibition of Reverse Transcription in Type I Interferon Mediated Neuropathology

CompletedPH IIUniversity of Edinburghn=132024

A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged >= 6 to <18 Years

CompletedPH IIJanssen Sciences Ireland UCn=542022

IGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect

CompletedN/AUniversity of North Carolina, Chapel Hilln=402021

Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients

CompletedPH IVFundacion Clinic per a la Recerca Biomédican=192020

Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens

CompletedPH IVJan Gerstoftn=432017

Pharmacokinetics of Abacavir Once Daily vs. Twice Daily and Lamivudine Once Daily vs. Twice Daily in HIV-infected Thai Children

CompletedPH II/IIIThe HIV Netherlands Australia Thailand Research Collaborationn=302015

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • AIDS (London, England)1
Leading researchers
  • Bi L1
  • Daar ES1
  • Diamond C1
  • Flaherty J1
  • Goicoechea M1
  • Ha B1
  • Haubrich R1
  • Jain S1
Leading institutions
free-text, unnormalised
  • University California San Diego1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.