Invirase

(Saquinavir)

ApprovedSmall molecule

Saquinavir is used to treat HIV infection by helping to stop the virus from multiplying in the body, usually as part of a combination treatment with other HIV medications.[2] Invirase is currently approved and in use across 4 indications[4].[1]

Invirase is one of 132 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

131

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

HIV-Associated NephropathyApproved

Pulmonary Arterial HypertensionApproved

HIV InfectionCompleted

Viral DiseaseApproved

Active, not recruiting

HIV-Associated NephropathyApproved

Approved

Pulmonary Arterial HypertensionApproved

Approved

HIV InfectionApproved

Completed

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Videx

Bristol-Myers Squibb

Approved

14 2

Viramune

Boehringer Ingelheim

Approved

11 3

Sustiva

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

10 4

Olumiant

Eli Lilly

Approved

1 5

Arava

Mycobutin

Cabenuva

Golytely

Hepsera

Zofran

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

Clinical

Trials by Indication[1]

Drug7 trials

A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000892·300 enrolled

A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00102206·6 enrolled

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

Show 4 more trials

A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients

Completed· Roche logo

Roche·Phase 3·NCT00002382·4,000 enrolled

A Study to Compare Two Anti-HIV Drug Combinations

Completed· Roche logo

Roche·Phase 3·NCT00002447·146 enrolled

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

Completed· GSK logo

GSK·Phase 1·NCT00002372·48 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

Treatment6 trials

A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients

Completed· Roche logo

Roche·Phase 1·NCT01638650·23 enrolled

A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

Completed· Roche logo

Roche·Phase 3·NCT00002178·375 enrolled

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

Show 3 more trials

Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00051831·19 enrolled

A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed· Roche logo

Roche·Phase 3·NCT00002367·40 enrolled

A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

Completed· Roche logo

Roche·Phase 3·NCT00002334·3,000 enrolled

Effectiveness6 trials

The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001087·300 enrolled

A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001108·6 enrolled

Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

Completed· Roche logo

Roche·Phase 4·NCT00002229·80 enrolled

Show 3 more trials

The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

Completed· Roche logo

Roche·Phase 4·NCT00002425·400 enrolled

The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Completed· Roche logo

Roche·Phase 1·NCT00002380·28 enrolled

Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00004584

HIV infection4 trials

A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

Completed· Roche logo

Roche·Phase 1·NCT00435929·16 enrolled

The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection

Completed·PParexel·Phase 2·NCT00002347·225 enrolled

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

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

Show 1 more trial

A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

Completed· Roche logo

Roche·Phase 2·NCT00002333·900 enrolled

HIV4 trials

A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients

Completed· Roche logo

Roche·Phase 1·NCT00002383·80 enrolled

A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

Completed·SStanford University·Phase 1·NCT00002111·32 enrolled

The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000848·144 enrolled

Show 1 more trial

A Comparison of Nelfinavir Plus Saquinavir Plus Delavirdine or 3TC/ZDV Versus Nelfinavir Plus 3TC/ZDV in HIV-Infected Patients

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001094

18 more indications

HIV-14 trials

A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

Completed· Roche logo

Roche·Phase 3·NCT00002374·120 enrolled

A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

Completed· Roche logo

Roche·Phase 3·NCT00002378·825 enrolled

Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02239835·79 enrolled

Show 1 more trial

Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00122603·61 enrolled

Children3 trials

A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.

Completed· Roche logo

Roche·Phase 2·NCT00623597·18 enrolled

A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000913·50 enrolled

Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00084058·26 enrolled

Interaction3 trials

Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000906·12 enrolled

A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000941·56 enrolled

The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000898·18 enrolled

HIV-1 infection1 trial

GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

Completed· Roche logo

Roche·Phase 3·NCT00105079·337 enrolled

MPA1 trial

Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Completed· Roche logo

Roche·Phase 2·NCT00001040·300 enrolled

Immune System1 trial

A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients

Completed· Roche logo

Roche·Phase 3·NCT00002448·40 enrolled

Completed· Roche logo

Roche·Phase 2·NCT00002162·140 enrolled

Phase II1 trial

A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

Completed· Roche logo

Roche·Phase 2·NCT00002190·30 enrolled

Pregnancy1 trial

Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000920·24 enrolled

Toxicity1 trial

Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 2·NCT00477048·30 enrolled

Safety and Efficacy1 trial

A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient

Completed· Gilead logo

Gilead·Phase 2·NCT00002184·120 enrolled

Function1 trial

Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

Completed· GSK logo

GSK·Phase 4·NCT00717067·30 enrolled

Drug Interactions1 trial

Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00005762·90 enrolled

Kidney Disease1 trial

A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease

Completed· Roche logo

Roche·Phase 3·NCT00002397·24 enrolled

Unspecified2 trials

Lopinavir Capsules to Kaletra or Invirase Tablets

Completed·RRoyal Free Hampstead NHS Trust·Phase 4·NCT00438152·53 enrolled

Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 4·NCT00050180·81 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 6, 1995

INVIRASE

NDA NDA020628

Nov 7, 1997

FORTOVASE

NDA NDA020828

Dec 17, 2004

INVIRASE

NDA NDA021785

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Saquinavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Invirase drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Saquinavir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Saquinavir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021785). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Invirase

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Drug7 trials

Treatment6 trials

Effectiveness6 trials

HIV infection4 trials

HIV4 trials

HIV-14 trials

Children3 trials

Interaction3 trials

HIV-1 infection1 trial

MPA1 trial

Immune System1 trial

Drug Resistance1 trial

Advanced1 trial

Treatment Failure1 trial

Randomized1 trial

Phase II1 trial

Pregnancy1 trial

Toxicity1 trial

Safety and Efficacy1 trial

Function1 trial

Drug Interactions1 trial

Kidney Disease1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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