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Last Updated: April 13, 2025

CLINICAL TRIALS PROFILE FOR GANCICLOVIR SODIUM


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All Clinical Trials for GANCICLOVIR SODIUM

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01199562 ↗ Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant Completed National Cancer Institute (NCI) 2010-12-01 RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV) infection caused by a stem cell transplant. PURPOSE:This clinical trial studies infection prophylaxis and management in treating cytomegalovirus infection in patients with hematologic malignancies previously treated with donor stem cell transplant.
NCT01199562 ↗ Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant Completed City of Hope Medical Center 2010-12-01 RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV) infection caused by a stem cell transplant. PURPOSE:This clinical trial studies infection prophylaxis and management in treating cytomegalovirus infection in patients with hematologic malignancies previously treated with donor stem cell transplant.
NCT00986557 ↗ T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant Unknown status University Hospital Birmingham Phase 2 2009-09-01 RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant. PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.
NCT00002034 ↗ A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS Completed Hoffmann-La Roche N/A 1969-12-31 To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for GANCICLOVIR SODIUM

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2Cytomegalovirus Anterior UveitisStage III Adult Immunoblastic Large Cell LymphomaPolycythemia VeraWaldenstrom Macroglobulinemia[disabled in preview]
Condition Name for GANCICLOVIR SODIUM
Intervention Trials
Cytomegalovirus Anterior Uveitis 2
Stage III Adult Immunoblastic Large Cell Lymphoma 1
Polycythemia Vera 1
Waldenstrom Macroglobulinemia 1
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Condition MeSH

3222000.511.522.53Cytomegalovirus InfectionsUveitis, AnteriorUveitisIridocyclitis[disabled in preview]
Condition MeSH for GANCICLOVIR SODIUM
Intervention Trials
Cytomegalovirus Infections 3
Uveitis, Anterior 2
Uveitis 2
Iridocyclitis 2
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Clinical Trial Locations for GANCICLOVIR SODIUM

Trials by Country

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Trials by Country for GANCICLOVIR SODIUM
Location Trials
United States 10
Canada 1
China 1
United Kingdom 1
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Trials by US State

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Trials by US State for GANCICLOVIR SODIUM
Location Trials
California 4
Texas 1
South Carolina 1
New York 1
Georgia 1
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Clinical Trial Progress for GANCICLOVIR SODIUM

Clinical Trial Phase

40.0%40.0%20.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 2/Phase 3Phase 2N/A[disabled in preview]
Clinical Trial Phase for GANCICLOVIR SODIUM
Clinical Trial Phase Trials
Phase 2/Phase 3 2
Phase 2 2
N/A 1
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Clinical Trial Status

33.3%33.3%33.3%0-0.200.20.40.60.811.21.41.61.822.2RecruitingUnknown statusCompleted[disabled in preview]
Clinical Trial Status for GANCICLOVIR SODIUM
Clinical Trial Phase Trials
Recruiting 2
Unknown status 2
Completed 2
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Clinical Trial Sponsors for GANCICLOVIR SODIUM

Sponsor Name

trials000111112222King Chulalongkorn Memorial HospitalNational Taiwan UniversityFrancis I. Proctor Foundation[disabled in preview]
Sponsor Name for GANCICLOVIR SODIUM
Sponsor Trials
King Chulalongkorn Memorial Hospital 2
National Taiwan University 2
Francis I. Proctor Foundation 2
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Sponsor Type

90.0%5.0%5.0%0024681012141618OtherIndustryNIH[disabled in preview]
Sponsor Type for GANCICLOVIR SODIUM
Sponsor Trials
Other 18
Industry 1
NIH 1
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Ganciclovir Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Ganciclovir sodium is a nucleoside analogue that has been widely used in the treatment of cytomegalovirus (CMV) infections, particularly in patients with compromised immune systems. This article delves into the recent clinical trials, market analysis, and future projections for ganciclovir sodium, highlighting its evolving role in medical treatment.

Clinical Trials and Efficacy

Ganciclovir in Glioma Treatment

Recent studies have explored the potential of ganciclovir in treating glioma, a type of brain tumor. A systematic review and meta-analysis published in 2023 indicated that ganciclovir, when combined with gene therapy, significantly improved the prognosis of glioma patients. The study showed improved 2-year and 4-year survival rates and overall survival compared to the control group[3].

Cerepro and Ganciclovir Combination

Although the application for Cerepro, a gene therapy product intended to be used with ganciclovir sodium for treating high-grade glioma, was withdrawn in 2010, the concept of combining gene therapy with ganciclovir remains promising. Cerepro was designed to deliver the thymidine kinase gene into tumor cells, which would then be targeted by ganciclovir, converting it into a form that kills dividing cancer cells[1].

CMV Infections

In the context of CMV infections, ganciclovir remains a cornerstone treatment. Studies have compared ganciclovir with other antiviral drugs like maribavir, showing that while maribavir may have certain advantages, such as a lower incidence of neutropenia, ganciclovir remains effective in preventing CMV disease in patients with weakened immune systems[4].

Market Analysis

Global Market Trends

The global ganciclovir sodium market is experiencing significant growth. The market size is projected to increase at a compound annual growth rate (CAGR) from 2024 to 2031, driven by factors such as the rising prevalence of CMV retinitis and congenital CMV infections, and increased initiatives for awareness and diagnosis of these conditions[5].

Regional Market Insights

The Japan generic ganciclovir sodium market, for example, is expected to grow at a CAGR of 7.13% from 2024 to 2031. This growth is fueled by the expansion of CMV treatment applications, ongoing research and development, and the increasing demand for antiviral treatments among patients with weakened immune systems, such as those with AIDS or undergoing organ transplants[2].

Key Players and Competitive Landscape

The market is characterized by several major players, including F. Hoffmann-La Roche AG, Fresenius Kabi, Thermo Fisher Scientific Inc., and Hikma Pharmaceuticals PLC. These companies are investing in clinical trials and formulation improvements to enhance the efficacy and safety profile of ganciclovir sodium, thereby expanding its market reach[2].

Market Projections

Forecasted Growth

The global ganciclovir sodium market is forecasted to continue its growth trajectory from 2025 to 2031. The market size and revenue are expected to increase, driven by the increasing demand for effective antiviral treatments and the ongoing research aimed at optimizing drug delivery mechanisms and minimizing adverse effects[5].

Segment Analysis

The market is segmented based on type and application. The hospital segment currently holds the largest market share, with ganciclovir sodium being extensively used in hospital settings for treating CMV infections in patients undergoing organ and bone marrow transplants, as well as those with AIDS[2].

Future Opportunities and Challenges

Future opportunities include the potential expansion of ganciclovir sodium's application range, particularly in the treatment of glioma and other cancers. However, challenges such as the development of resistance and the need for continuous innovation to improve efficacy and safety will need to be addressed.

Illustrative Statistics

  • Market Growth Rate: The Japan generic ganciclovir sodium market is expected to grow at a CAGR of 7.13% from 2024 to 2031[2].
  • Survival Rates: Ganciclovir improved 2-year and 4-year survival rates in glioma patients, with a risk difference of 0.179 and 0.185, respectively[3].
  • Market Size: The global ganciclovir sodium market size was significant in 2023 and is projected to grow further from 2025 to 2031[5].

Quotes from Industry Experts

"Ganciclovir, when combined with gene therapy, has shown promising results in treating glioma, a challenging malignant tumor with a low survival rate." - [Meta-analysis on ganciclovir in glioma treatment][3].

Key Takeaways

  • Clinical Efficacy: Ganciclovir sodium has shown significant efficacy in treating CMV infections and has potential in treating glioma when combined with gene therapy.
  • Market Growth: The global and regional markets for ganciclovir sodium are expected to grow, driven by increasing demand and ongoing research.
  • Competitive Landscape: Major pharmaceutical companies are investing in clinical trials and formulation improvements to enhance the drug's efficacy and safety.
  • Future Prospects: The drug's application range may expand, but addressing challenges such as resistance and adverse effects will be crucial.

FAQs

What is ganciclovir sodium used for?

Ganciclovir sodium is primarily used to treat cytomegalovirus (CMV) infections, particularly in patients with weakened immune systems, such as those undergoing organ transplants or with AIDS.

How does ganciclovir sodium work in treating glioma?

Ganciclovir sodium works in treating glioma by converting into a form that kills dividing cancer cells when combined with gene therapy that delivers the thymidine kinase gene into tumor cells.

What is the current market trend for ganciclovir sodium?

The market for ganciclovir sodium is growing, with a projected CAGR from 2024 to 2031, driven by increasing demand and ongoing research to improve efficacy and safety.

Who are the key players in the ganciclovir sodium market?

Key players include F. Hoffmann-La Roche AG, Fresenius Kabi, Thermo Fisher Scientific Inc., and Hikma Pharmaceuticals PLC, among others.

What are the future opportunities and challenges for ganciclovir sodium?

Future opportunities include expanding the drug's application range, particularly in cancer treatment, while challenges include addressing resistance and adverse effects through continuous innovation.

Sources

  1. European Medicines Agency (EMA). Cerepro | European Medicines Agency (EMA).
  2. Verified Market Research. Japan Generic Ganciclovir Sodium Market Size, Forecast.
  3. PubMed. Ganciclovir as a potential treatment for glioma: a systematic review ...
  4. Oxford Academic. Treatment for First Cytomegalovirus Infection Post–Hematopoietic ...
  5. Cognitive Market Research. Global Ganciclovir Sodium Market Report 2024 Edition, Market Size ...

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