Agenerase

(Amprenavir)

ApprovedSmall molecule

Agenerase is a small molecule that works as a Human Immunodeficiency Virus Type 1 Protease Inhibitor.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Agenerase is one of 138 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

137

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

HIV-1 InfectionActive, not recruiting

MPRCompleted

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionPreclinical

Active, not recruiting

MPRPreclinical

Completed

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Retrovir

BBp Consulting, Inc

Approved

36 2

Tivicay

GSK

Approved

7 3

Zerit

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

13 4

Viramune

Boehringer Ingelheim

Approved

11 5

Invirase

Roche

Approved

4 6

Agenerase

GGlaxo Dba Glaxosmithkline

Approved

4 7

Aralen

Avelox

Zofran

Hepsera

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

Clinical

Trials by Indication[1]

Drug7 trials

Once-Daily Drug Regimen for HIV-Infected Patients

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

A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

Completed· GSK logo

GSK·Phase 2·NCT00002423·100 enrolled

A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001095·94 enrolled

Show 4 more trials

A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000912·475 enrolled

A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed· GSK logo

GSK·Phase 2·NCT00002440·80 enrolled

A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs

Completed· GSK logo

GSK·N/A·NCT00002217

A Study of 141W94 in Combination With Other Anti-HIV Drugs

Completed· GSK logo

GSK·Phase 1·NCT00002372·48 enrolled

Treatment5 trials

A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00006152·42 enrolled

A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

Completed· GSK logo

GSK·N/A·NCT00002216

Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000940·121 enrolled

Show 2 more trials

Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment

Unknown status·—·N/A·NCT00006591

Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00056641·328 enrolled

Effectiveness4 trials

Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment

Unknown status· GSK logo

GSK·Phase 4·NCT00005017·300 enrolled

Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment

Completed· Gilead logo

Gilead·Phase 2·NCT00002419·25 enrolled

Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

Completed· GSK logo

GSK·Phase 3·NCT00002193·210 enrolled

Show 1 more trial

The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors

Completed· GSK logo

GSK·Phase 2·NCT00002213·80 enrolled

HIV infection4 trials

A Study of a Combination of Four Drugs in Patients With Recent HIV Infection

Completed· GSK logo

GSK·Phase 2·NCT00002233·30 enrolled

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

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

A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection

Completed· GSK logo

GSK·Phase 1·NCT00002183·60 enrolled

Show 1 more trial

A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000919·900 enrolled

MPR3 trials

Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00196625·100 enrolled

A Study of Amprenavir in HIV-Infected Patients

Completed· GSK logo

GSK·N/A·NCT00002405

Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001758·25 enrolled

13 more indications

HIV3 trials

A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001085·94 enrolled

A Comparison of 141W94 and Indinavir in HIV-Infected Patients

Completed· GSK logo

GSK·Phase 3·NCT00002202·460 enrolled

A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

Completed· GSK logo

GSK·Phase 3·NCT00002195·290 enrolled

Adult1 trial

A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

Completed· Roche logo

Roche·Phase 2·NCT00002239·68 enrolled

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182765·8 enrolled

Fat Metabolism1 trial

A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients

Completed· GSK logo

GSK·Phase 3·NCT00002245

Combination Therapy1 trial

Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00006617·25 enrolled

Immune Response1 trial

Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00006578

Immune System1 trial

Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001119·288 enrolled

Complication1 trial

A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications

Completed· GSK logo

GSK·N/A·NCT00002417

HIV-1 infection1 trial

An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects With HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen

Completed· GSK logo

GSK·N/A·NCT00002205

Drug Resistance1 trial

Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug Resistance

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00046033·118 enrolled

Treatment Failure1 trial

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000918·300 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 15, 1999

AGENERASE

NDA NDA021007

Apr 15, 1999

AGENERASE

NDA NDA021039

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Amprenavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amprenavir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Amprenavir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021007). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Protease Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Agenerase

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Drug7 trials

Treatment5 trials

Effectiveness4 trials

HIV infection4 trials

MPR3 trials

HIV3 trials

Adult1 trial

Pregnancy1 trial

Drug Interactions1 trial

Interaction1 trial

Fat Metabolism1 trial

Combination Therapy1 trial

Immune Response1 trial

Immune System1 trial

Complication1 trial

HIV-1 infection1 trial

Drug Resistance1 trial

Treatment Failure1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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