CLINICAL TRIALS PROFILE FOR GANCICLOVIR

All Clinical Trials for GANCICLOVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Baylor College of Medicine	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Icahn School of Medicine at Mount Sinai	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Johns Hopkins University	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Memorial Sloan Kettering Cancer Center	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	National Eye Institute (NEI)	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	New York Presbyterian Hospital	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.

Clinical Trial Conditions for GANCICLOVIR

Condition Name

Condition Name for GANCICLOVIR
Intervention	Trials
HIV Infections	54
Cytomegalovirus Retinitis	41
Cytomegalovirus Infections	32
Lymphoma	6

Condition MeSH

Condition MeSH for GANCICLOVIR
Intervention	Trials
HIV Infections	55
Cytomegalovirus Infections	50
Cytomegalovirus Retinitis	43
Infections	43

Clinical Trial Locations for GANCICLOVIR

Trials by Country

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Trials by Country for GANCICLOVIR
Location	Trials
United States	477
France	23
United Kingdom	19
Canada	17
Italy	12

Trials by US State

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−

Trials by US State for GANCICLOVIR
Location	Trials
California	55
New York	41
Texas	29
Illinois	27
Florida	26

Clinical Trial Progress for GANCICLOVIR

Clinical Trial Phase

Clinical Trial Phase for GANCICLOVIR
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	28
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for GANCICLOVIR
Clinical Trial Phase	Trials
Completed	98
Unknown status	16
Recruiting	16

Clinical Trial Sponsors for GANCICLOVIR

Sponsor Name

Sponsor Name for GANCICLOVIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	36
Hoffmann-La Roche	26
National Cancer Institute (NCI)	12

Sponsor Type

Sponsor Type for GANCICLOVIR
Sponsor	Trials
Other	162
Industry	70
NIH	58

Ganciclovir: Clinical Trials, Market Analysis, and Projections

Introduction

Ganciclovir, an antiviral medication, is primarily used to treat cytomegalovirus (CMV) infections, particularly in immunocompromised patients such as those undergoing hematopoietic stem cell transplantation or solid-organ transplantation. Here, we will delve into the latest clinical trials, market analysis, and projections for ganciclovir.

Clinical Trials Update

Comparison with Maribavir

A significant clinical trial, the AURORA trial, compared the efficacy and safety of maribavir with valganciclovir (the prodrug of ganciclovir) for the pre-emptive treatment of the first asymptomatic CMV infection following hematopoietic cell transplantation (HCT). The trial found that maribavir had a lower incidence of neutropenia compared to valganciclovir but aimed to establish noninferiority of maribavir for CMV viremia clearance. The primary endpoint was confirmed CMV viremia clearance at week 8, with maribavir showing promising results in terms of safety and efficacy[1].

Topical and Oral Treatments

Another ongoing clinical trial at UCSF is comparing the efficacy of oral valganciclovir with topical ganciclovir 2% for the control of CMV. This trial aims to evaluate the most effective method of CMV control, highlighting the ongoing research into optimizing ganciclovir treatment protocols[4].

Ganciclovir in Glioma Treatment

Interestingly, ganciclovir has also been explored as a potential treatment for glioma, a type of brain tumor. A systematic review and meta-analysis showed that ganciclovir, when combined with gene therapy, significantly improved the prognosis of glioma patients, suggesting a new avenue for its use[3].

Market Analysis

Market Size and Growth

The ganciclovir market is experiencing moderate to significant growth driven by the increasing incidence and prevalence of CMV diseases globally. Government initiatives and rising health awareness are key factors propelling this growth. The market is expected to continue growing substantially in the forecast period, driven by the demand for effective treatments for CMV infections[2].

Key Players

Major players in the ganciclovir market include Roche, Luitpold, Bausch & Lomb, Fresenius Kabi, Huatai Pharmaceutical, Luxin, HUBEI KEYI, Wuhan Hualong Bio-pharmaceutical, Tiantianming, and Tungshun Group. These companies are investing heavily in research and development, which is expected to drive innovation and market expansion[2].

Regional Market

The global ganciclovir market is segmented by geography, with North America, Europe, and the Asia Pacific being key regions. The market in these regions is driven by advanced healthcare infrastructure, higher awareness of CMV diseases, and significant investment in healthcare research and development[2].

Market Projections

Forecasted Growth

The ganciclovir market is projected to grow significantly in the forecast period, driven by the increasing demand for personalized medicines and better diagnostic facilities. Emerging markets and substantial investments in research and development are expected to further boost market growth[2].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as strict drug regulatory systems and high drug pricing. However, new treatment options and technological breakthroughs are anticipated to open new avenues for market growth. The report from Maiaresearch highlights that the global ganciclovir sodium consumption market will see significant growth in terms of volume, revenue, and price forecast from 2018 to 2025[5].

Consumer Needs and Market Dynamics

Driving Factors

The rise in CMV disease incidence, government initiatives, and increased health awareness are major drivers of the ganciclovir market. Additionally, the demand for personalized medicines and better diagnostic facilities is expected to propel market growth[2].

Restraining Factors

High drug pricing and strict regulatory systems are significant restraints on the market. However, ongoing research and development are expected to mitigate these challenges by introducing more affordable and effective treatment options[2].

Conclusion

Ganciclovir remains a crucial antiviral medication in the treatment of CMV infections, with ongoing clinical trials aiming to optimize its use. The market for ganciclovir is growing, driven by increasing demand and advancements in healthcare. Despite challenges, the future looks promising with new treatment options and technological breakthroughs on the horizon.

Key Takeaways

• Clinical Trials: Ganciclovir is being compared with other antivirals like maribavir and is being explored for new uses such as glioma treatment.
• Market Growth: The ganciclovir market is expected to grow significantly due to the rise in CMV disease incidence and government initiatives.
• Key Players: Major pharmaceutical companies are investing in research and development to drive market growth.
• Regional Market: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Challenges and Opportunities: High drug pricing and regulatory challenges are balanced by new treatment options and technological advancements.

FAQs

What is the primary use of ganciclovir?

Ganciclovir is primarily used to treat cytomegalovirus (CMV) infections, especially in immunocompromised patients.

How does ganciclovir compare to maribavir in clinical trials?

Ganciclovir (via its prodrug valganciclovir) has been compared to maribavir in clinical trials, with maribavir showing a lower incidence of neutropenia but aiming to establish noninferiority for CMV viremia clearance[1].

Is ganciclovir being explored for other medical conditions?

Yes, ganciclovir is being explored as a potential treatment for glioma, a type of brain tumor, showing promising results in improving patient prognosis[3].

What are the key drivers of the ganciclovir market?

The key drivers include the rise in CMV disease incidence, government initiatives, and increased health awareness, as well as the demand for personalized medicines and better diagnostic facilities[2].

What challenges does the ganciclovir market face?

The market faces challenges such as strict drug regulatory systems and high drug pricing, although these are expected to be mitigated by ongoing research and development[2].

Who are the major players in the ganciclovir market?

Major players include Roche, Luitpold, Bausch & Lomb, Fresenius Kabi, and several other pharmaceutical companies[2].

Sources

1. Papanicolaou, G. A., et al. "Treatment for First Cytomegalovirus Infection Post–Hematopoietic Cell Transplantation: A Phase 3 Trial Comparing Maribavir with Valganciclovir." Clinical Infectious Diseases, vol. 78, no. 3, 2023, pp. 562-571.
2. Verified Market Research. "Ganciclovir Market Size, Share, Trends, Analysis, Scope & Forecast."
3. "Ganciclovir as a potential treatment for glioma: a systematic review and meta-analysis." PubMed, 2023.
4. UCSF Clinical Trials. "Systemic and Topical Antivirals for Control of Cytomegalovirus."
5. Maiaresearch. "Global Ganciclovir Sodium Consumption Market Research Report 2013-2025."