Ziagen
(Abacavir)ApprovedSmall molecule
GSKAbacavir 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 194 small molecule programs targeting HIV infection. It is currently in Approved.
9
Indications
41
Total Trials
2
Active Trials
193
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
123 competitors in HIV Infection
#DrugCompanyPhaseTrials
1Retrovir
BBp Consulting, Inc
Approved
Videx
Bristol-Myers SquibbApproved
Norvir
AbbVieApproved
Tivicay
GSKApproved
Epivir
GGlaxo Dba Glaxosmithkline
Approved
Zerit
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Viramune
Boehringer IngelheimApproved
Sustiva
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Lialda
TakedaApproved
Olumiant
Eli LillyApproved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
HIV5 trials
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
HIV infection4 trials
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
Effectiveness3 trials
Tenofovir3 trials
22 more indications
Children2 trials
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
Abacavir and Lamivudine PK in Children
Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 2/3·NCT01656122·30 enrolled
Hepatitis B1 trial
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
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
HIV-11 trial
Interaction1 trial
Tenofovir Disoproxil Fumarate1 trial
MPR1 trial
Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001758·25 enrolled
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
Drug1 trial
Once-Daily Drug Regimen for HIV-Infected Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001968·25 enrolled
Treatment1 trial
Treatment Options for Protease Inhibitor-exposed Children
Completed·—·Phase 3·NCT01146873·300 enrolled
Solid Organ Transplant1 trial
Combination Therapy1 trial
Study of Options for Second-Line Effective Combination Therapy (SELECT)
Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT01352715·515 enrolled
Tuberculosis1 trial
Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00078247·350 enrolled
Immunodeficiency1 trial
High Grade Glioma1 trial
Regulatory
FDA Approval Timeline[5]
Dec 17, 1998
ZIAGEN
NDA NDA020978
Dec 17, 1998
ZIAGEN
NDA NDA020977
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Ziagen drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Abacavir. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]