CLINICAL TRIALS PROFILE FOR FOSCAVIR

All Clinical Trials for FOSCAVIR

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.

Clinical Trial Conditions for FOSCAVIR

Condition Name

Condition Name for FOSCAVIR
Intervention	Trials
HIV Infections	7
Cytomegalovirus Retinitis	4
Cytomegalovirus Infections	2
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma	1

Condition MeSH

Condition MeSH for FOSCAVIR
Intervention	Trials
HIV Infections	7
Retinitis	5
Cytomegalovirus Retinitis	5
Cytomegalovirus Infections	3

Clinical Trial Locations for FOSCAVIR

Trials by Country

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Trials by Country for FOSCAVIR
Location	Trials
United States	18

Trials by US State

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−

Trials by US State for FOSCAVIR
Location	Trials
California	3
Texas	2
New York	2
Michigan	2
Georgia	2

Clinical Trial Progress for FOSCAVIR

Clinical Trial Phase

Clinical Trial Phase for FOSCAVIR
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for FOSCAVIR
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	1

Clinical Trial Sponsors for FOSCAVIR

Sponsor Name

Sponsor Name for FOSCAVIR
Sponsor	Trials
Johns Hopkins Bloomberg School of Public Health	4
Northwestern University	3
University of California, Los Angeles	3

Sponsor Type

Sponsor Type for FOSCAVIR
Sponsor	Trials
Other	49
Industry	4
NIH	4

FOSCAVIR: Clinical Trials, Market Analysis, and Projections

Introduction

FOSCAVIR, or foscarnet sodium, is a synthetic guanine analog with potent antiviral properties, particularly effective against cytomegalovirus (CMV) and herpes simplex virus (HSV) infections. Here, we delve into the clinical trials, market analysis, and future projections for this crucial antiviral drug.

Clinical Trials Overview

CMV Retinitis Trials

FOSCAVIR has been extensively studied in clinical trials for the treatment of CMV retinitis in patients with AIDS. Key trials include:

• FOS-03 Trial: This prospective, randomized, controlled clinical trial compared FOSCAVIR treatment with no treatment in 24 patients with AIDS and CMV retinitis. Patients receiving FOSCAVIR showed a significant delay in retinitis progression, with median times to progression of 93 days compared to 22 days for untreated controls[1][3].
• ACTG-915 Trial: This trial involved 33 patients treated with FOSCAVIR induction followed by either 90 mg/kg/day or 120 mg/kg/day maintenance therapy. The median times to retinitis progression were 96 and 140 days, respectively, indicating no significant difference between the two maintenance doses[1][3].
• ACTG 129/FGCRT SOCA Study: This study compared FOSCAVIR with ganciclovir in 107 and 127 patients, respectively. The median time to progression was similar for both drugs, at 59 days for FOSCAVIR and 56 days for ganciclovir[1][3].

Combination Therapy Trials

The CMV Retinitis Retreatment Trial (ACTG 228/SOCA CRRT) evaluated FOSCAVIR, ganciclovir, and the combination of both drugs for treating relapsed CMV retinitis. The combination therapy showed the best outcomes, with a median time to retinitis progression or death of 105 days, significantly better than monotherapy with either drug[1][3].

HSV Infections Trials

FOSCAVIR has also been studied for the treatment of mucocutaneous, acyclovir-resistant HSV infections. In one trial, patients treated with FOSCAVIR showed lesion healing times ranging from 11 to 30 days, demonstrating its efficacy in this context[1].

Market Analysis

Global Market

The global FOSCAVIR market is segmented by region, type, and application. Key players include MedChemExpress, Santa Cruz Biotechnology, America's Pharmacy, Biosynth, and MilliporeSigma. The market is expected to grow, driven by increasing demand for antiviral treatments, particularly in regions with high prevalence of HIV/AIDS and other immunocompromising conditions[2].

Regional Market

• North America: The U.S. market is a significant segment, with revenue expected to grow at a steady CAGR from 2023 to 2030. This growth is fueled by the ongoing need for effective treatments for CMV and HSV infections[2].
• Europe, Asia Pacific, and Other Regions: These regions also show promising growth potential, with varying CAGRs reflecting local healthcare infrastructure and disease prevalence[2].

Market Segmentation

The market is segmented by type (purity levels such as 99% and 98%) and application (laboratory, chemical industry, and others). This segmentation helps in understanding the diverse uses of FOSCAVIR and its potential in different sectors[2].

Market Projections

Revenue Growth

The global FOSCAVIR market is projected to experience significant revenue growth from 2023 to 2030. In the United States, the revenue is expected to increase at a notable CAGR during this period, driven by the increasing demand for antiviral medications and the introduction of generic versions of FOSCAVIR[2].

Generic Market Impact

The introduction of the first generic version of FOSCAVIR by Fresenius Kabi in 2021 is expected to impact the market positively by increasing accessibility and reducing costs for patients. This development is likely to expand the market reach and contribute to the overall growth of the FOSCAVIR market[5].

Safety and Efficacy

Renal Impairment

FOSCAVIR use is associated with renal impairment, and its administration requires careful monitoring of renal function. Clinical trials have highlighted the importance of adjusting dosages in patients with renal issues to minimize adverse effects[1][3].

Antiviral Resistance

While FOSCAVIR is effective against various viral strains, including those resistant to other antivirals, there is a potential for the development of resistance. Continuous monitoring and adaptation of treatment protocols are essential to maintain its efficacy[1][3].

Key Takeaways

• Clinical Efficacy: FOSCAVIR has demonstrated significant efficacy in treating CMV retinitis and acyclovir-resistant HSV infections in clinical trials.
• Market Growth: The global FOSCAVIR market is expected to grow, driven by increasing demand and the introduction of generic versions.
• Regional Variations: Market growth varies by region, with North America being a significant segment.
• Safety Considerations: Renal impairment is a critical safety concern, necessitating careful patient monitoring.
• Generic Impact: The introduction of generic FOSCAVIR is expected to increase market accessibility and reduce costs.

FAQs

What is FOSCAVIR used for?

FOSCAVIR is primarily used for the treatment of CMV retinitis in patients with AIDS and for mucocutaneous, acyclovir-resistant HSV infections.

What are the key clinical trials for FOSCAVIR?

Key trials include FOS-03, ACTG-915, ACTG 129/FGCRT SOCA study, and the CMV Retinitis Retreatment Trial (ACTG 228/SOCA CRRT).

How does FOSCAVIR compare to ganciclovir in treating CMV retinitis?

FOSCAVIR and ganciclovir have been shown to be equally effective in controlling CMV retinitis, although combination therapy with both drugs may offer better outcomes.

What are the potential side effects of FOSCAVIR?

A significant side effect of FOSCAVIR is renal impairment, which requires careful monitoring and dosage adjustments.

Is there a generic version of FOSCAVIR available?

Yes, the first generic version of FOSCAVIR was introduced by Fresenius Kabi in 2021, which is expected to increase market accessibility and reduce costs.

Sources

1. FOSCAVIR - accessdata.fda.gov
2. Global and United States Foscarnet Market Report & Forecast 2024-2030 - qyresearch.com
3. FOSCAVIR (foscarnet sodium) INJECTION - labeling.pfizer.com
4. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial - PubMed
5. Fresenius Kabi Introduces First-Ever Generic for Foscavir® Foscarnet Sodium Injection - businesswire.com