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Last Updated: April 17, 2025

CLINICAL TRIALS PROFILE FOR SAQUINAVIR MESYLATE


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All Clinical Trials for Saquinavir Mesylate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001040 ↗ Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC Completed Hoffmann-La Roche Phase 2 1969-12-31 PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.
NCT00002111 ↗ A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. Completed Stanford University Phase 1 1969-12-31 To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.
NCT00002333 ↗ 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 Hoffmann-La Roche Phase 2 1969-12-31 To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).
NCT00002334 ↗ 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 Hoffmann-La Roche Phase 3 1969-12-31 To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
NCT00003008 ↗ Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma Completed AIDS Associated Malignancies Clinical Trials Consortium Phase 2 1997-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposi's sarcoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Saquinavir Mesylate

Condition Name

Condition Name for Saquinavir Mesylate
Intervention Trials
HIV Infections 6
Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID 1
Sarcoma 1
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Condition MeSH

Condition MeSH for Saquinavir Mesylate
Intervention Trials
HIV Infections 6
Acquired Immunodeficiency Syndrome 2
Sarcoma, Kaposi 1
Sarcoma 1
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Clinical Trial Locations for Saquinavir Mesylate

Trials by Country

Trials by Country for Saquinavir Mesylate
Location Trials
United States 52
Canada 4
Puerto Rico 3
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Trials by US State

Trials by US State for Saquinavir Mesylate
Location Trials
California 5
Massachusetts 4
Ohio 4
New York 4
Illinois 3
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Clinical Trial Progress for Saquinavir Mesylate

Clinical Trial Phase

Clinical Trial Phase for Saquinavir Mesylate
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 1
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Saquinavir Mesylate
Clinical Trial Phase Trials
Completed 7
Withdrawn 1
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Clinical Trial Sponsors for Saquinavir Mesylate

Sponsor Name

Sponsor Name for Saquinavir Mesylate
Sponsor Trials
Hoffmann-La Roche 3
Stanford University 1
AIDS Associated Malignancies Clinical Trials Consortium 1
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Sponsor Type

Sponsor Type for Saquinavir Mesylate
Sponsor Trials
Other 5
Industry 4
NIH 2
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Saquinavir Mesylate: Clinical Trials, Market Analysis, and Projections

Introduction to Saquinavir Mesylate

Saquinavir mesylate, known by its alternative name Ro 31-8959, is a potent inhibitor of the human immunodeficiency virus (HIV) protease. It was the first protease inhibitor developed for HIV therapy, significantly altering the treatment landscape for this disease by introducing combination therapy regimens[3].

Mechanism of Action and Clinical Use

Saquinavir mesylate works by binding to the HIV-1 protease, preventing the cleavage of viral Gag-Pol polyprotein precursors into functional proteins necessary for the formation of infectious HIV particles. This results in the production of immature, noninfectious viral particles[4].

Due to its poor oral bioavailability, saquinavir is often used in combination with ritonavir, another protease inhibitor that inhibits the CYP3A4 enzyme and the P-glycoprotein (P-gp) transporter, thereby increasing saquinavir's bioavailability and efficacy[3].

Clinical Trials and Efficacy

HIV Treatment

Clinical trials have demonstrated the efficacy of saquinavir mesylate in combination with other antiretroviral drugs for the treatment of HIV-1 infection. Studies such as PACTG 397 have shown that saquinavir combined with ritonavir and nucleoside reverse transcriptase inhibitors (NRTIs) is well-tolerated and effective in reducing viral loads and improving immune function[4].

Pediatric Studies

Despite efforts to evaluate saquinavir mesylate for pediatric use, challenges in pharmacokinetic (PK) bioanalyses and method validation issues have hindered the approval of this drug for patients under 16 years old. Further studies are needed to establish reliable PK data for this age group[4].

COVID-19 and Cancer Treatment

Recent research has explored the potential of saquinavir mesylate in treating COVID-19 and certain types of cancer. For COVID-19, saquinavir has shown inhibitory activity against the SARS-CoV-2 3CLpro protease, suggesting its potential as a therapeutic agent[3].

In cancer treatment, particularly for cervical cancer and neuroblastoma, saquinavir has demonstrated antiproliferative and proapoptotic effects, although more in vivo studies are required to confirm these findings[3].

Market Analysis

Global Market Value and Growth

The global saquinavir mesylate market has experienced significant growth. As of 2022, the market was valued at USD XXX million and is projected to reach USD XXX million by 2029, with a compound annual growth rate (CAGR) of X.X% during the forecast period[2].

Regional Market Segmentation

The market is segmented by region, with key markets including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Major countries covered in these regions include the United States, Canada, Germany, the UK, France, China, Japan, and India[2].

Impact of COVID-19 and Regional Conflicts

The COVID-19 pandemic has had a notable impact on the saquinavir mesylate market, affecting supply chains, consumer behavior, and overall market dynamics. Regional conflicts, such as the Russia-Ukraine war, have also influenced the market by disrupting trade flows and raw material availability[2].

Market Challenges and Opportunities

Challenges

The saquinavir mesylate market faces several challenges, including the poor oral bioavailability of the drug, which necessitates combination therapy with ritonavir. Additionally, the market has been impacted by the COVID-19 pandemic and regional conflicts, leading to supply chain disruptions and changes in consumer demand[2].

Opportunities

Despite these challenges, there are significant opportunities for growth. The repurposing of saquinavir mesylate for COVID-19 and cancer treatment opens new avenues for market expansion. Furthermore, advancements in drug delivery systems and the development of new combination therapies could enhance the drug's efficacy and market appeal[2][3].

Competitive Landscape

The global saquinavir mesylate market is characterized by a competitive landscape with several prominent players. These companies are comprehensively analyzed in market reports, which provide insights into their market shares, performance, and strategic initiatives. The concentration ratio and detailed data on each player's market performance help in understanding the competitive situation[2].

Technological Developments and Industry News

Technological advancements in the field of protease inhibitors continue to shape the market. Molecular docking studies and in silico models have predicted the potential of saquinavir mesylate as an inhibitor of SARS-CoV-2 3CLpro, highlighting its versatility beyond HIV treatment[1][3].

Market Investment Scenario and Strategic Recommendations

Investors and market participants are advised to consider the long-term potential of saquinavir mesylate, especially with its emerging applications in COVID-19 and cancer treatment. Strategic recommendations include diversifying product portfolios, investing in research and development, and forming strategic partnerships to enhance market presence and competitiveness[2].

Key Takeaways

  • Clinical Efficacy: Saquinavir mesylate is effective in treating HIV-1 infection, particularly when used in combination with ritonavir.
  • Market Growth: The global market is projected to grow with a CAGR of X.X% from 2022 to 2029.
  • Regional Impact: The market is influenced by regional factors such as the COVID-19 pandemic and regional conflicts.
  • New Applications: Saquinavir mesylate shows potential in treating COVID-19 and certain cancers.
  • Competitive Landscape: The market is competitive, with several key players dominating the scene.

FAQs

1. What is saquinavir mesylate used for?

Saquinavir mesylate is primarily used for the treatment of HIV-1 infection. It is also being explored for its potential in treating COVID-19 and certain types of cancer.

2. Why is saquinavir mesylate often used in combination with ritonavir?

Saquinavir mesylate is often used in combination with ritonavir because ritonavir inhibits the CYP3A4 enzyme and the P-glycoprotein (P-gp) transporter, thereby increasing the bioavailability and efficacy of saquinavir.

3. How has the COVID-19 pandemic affected the saquinavir mesylate market?

The COVID-19 pandemic has disrupted supply chains, affected consumer behavior, and impacted overall market dynamics, but it has also opened new avenues for saquinavir mesylate as a potential therapeutic agent against COVID-19.

4. What are the challenges faced by the saquinavir mesylate market?

The market faces challenges such as poor oral bioavailability of the drug, supply chain disruptions due to COVID-19 and regional conflicts, and changes in consumer demand.

5. What are the future prospects for saquinavir mesylate?

The future prospects for saquinavir mesylate are promising, with potential applications in COVID-19 and cancer treatment, and ongoing technological developments aimed at enhancing its efficacy and market appeal.

Cited Sources

  1. R&D Systems: Saquinavir mesylate | HIV Protease Inhibitors - R&D Systems.
  2. Maia Research: Global SAQUINAVIR MESYLATE Industry Market ... - Maia Research.
  3. MDPI: Saquinavir: From HIV to COVID-19 and Cancer Treatment - MDPI.
  4. FDA: INVIRASEĀ® (saquinavir mesylate) - FDA.
  5. Ricerca Alfa: Saquinavir Mesylate Industry Report for Global and China.

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