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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR FOSCARNET SODIUM


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All Clinical Trials for Foscarnet Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000665 ↗ Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component Completed Johns Hopkins University N/A 1969-12-31 To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis; to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3. CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.
NCT00000665 ↗ Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis; to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3. CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.
NCT00000691 ↗ A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation of the retina in one or both eyes (CMV retinitis). Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on the body's blood-forming cells, because it did not control the disease, or because patient's blood cell or platelet counts are too low to begin with), it is worthwhile to try an immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17, 1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance therapy following the 2 week induction period. Based on the preliminary results of ACTG 015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120 mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All patients entering the study beginning January 2, 1990 will receive foscarnet maintenance therapy on a 120/mg/kg/day algorithm following induction.
NCT00000697 ↗ A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To study the safety and effectiveness of foscarnet in the treatment of AIDS patients who have active infection with cytomegalovirus (CMV) that is causing inflammation of the retina (retinitis). In addition, these patients cannot be treated with ganciclovir (DHPG) because of its toxic effect on the body's blood-forming cells or because white blood cell or platelet counts were too low. CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection. Although treatment with ganciclovir (DHPG) is also effective, a significant toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of treated patients has been associated with the drug. Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients with CMV retinitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Foscarnet Sodium

Condition Name

Condition Name for Foscarnet Sodium
Intervention Trials
HIV Infections 21
Cytomegalovirus Retinitis 11
Herpes Simplex 4
Refractory Chronic Lymphocytic Leukemia 1
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Condition MeSH

Condition MeSH for Foscarnet Sodium
Intervention Trials
HIV Infections 21
Infections 14
Infection 14
Retinitis 11
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Clinical Trial Locations for Foscarnet Sodium

Trials by Country

Trials by Country for Foscarnet Sodium
Location Trials
United States 80
China 1
United Kingdom 1
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Trials by US State

Trials by US State for Foscarnet Sodium
Location Trials
California 13
New York 11
Illinois 6
Texas 5
Ohio 4
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Clinical Trial Progress for Foscarnet Sodium

Clinical Trial Phase

Clinical Trial Phase for Foscarnet Sodium
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Foscarnet Sodium
Clinical Trial Phase Trials
Completed 20
Unknown status 2
Withdrawn 2
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Clinical Trial Sponsors for Foscarnet Sodium

Sponsor Name

Sponsor Name for Foscarnet Sodium
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 12
Astra USA 10
Hoffmann-La Roche 1
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Sponsor Type

Sponsor Type for Foscarnet Sodium
Sponsor Trials
NIH 13
Industry 13
Other 4
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Foscarnet Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Foscarnet Sodium

Foscarnet sodium is a small molecule drug that acts as a DNA polymerase inhibitor, primarily used in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS and acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients[1][4][5].

Clinical Trials Update

CMV Retinitis Trials

Several clinical trials have been conducted to evaluate the efficacy and safety of foscarnet sodium in treating CMV retinitis. A prospective, randomized, controlled clinical trial (FOS-03) involved 24 patients with AIDS and CMV retinitis, comparing treatment with foscarnet sodium injection to no treatment. The results showed a significant delay in the progression of CMV retinitis in patients treated with foscarnet sodium, with median times to retinitis progression of 93 days compared to 22 days for untreated controls[5].

Another trial, ACTG-915, involved 33 patients treated with foscarnet sodium injection for induction followed by maintenance therapy. This study also demonstrated a delay in the progression of CMV retinitis, with healing of lesions observed in the treated patients[5].

Adverse Events and Safety

Clinical trials have highlighted several adverse events associated with foscarnet sodium. These include fever, fatigue, rigors, asthenia, and more severe events such as seizures, QT prolongation, and torsades de pointes. The risk of seizures is particularly high in patients with impaired renal function, low total serum calcium, and underlying CNS conditions[1].

Resistance and Drug Interactions

Foscarnet-resistant CMV and HSV isolates have been identified through cell culture studies, involving amino acid substitutions in the viral DNA polymerase. Clinical trials have also shown that foscarnet sodium can be used in combination with other antiviral drugs like ganciclovir without significant pharmacokinetic interactions. However, it should be avoided in combination with agents known to prolong the QT interval[1][5].

Market Analysis

Global Market Overview

The foscarnet sodium market is analyzed across various regions including North America, Europe, Asia-Pacific (APAC), South America, and the Middle East and Africa (MEA). The market size, volume, and compound annual growth rate (CAGR) are evaluated for each region.

  • North America: The US market is a significant segment, with Hikma Pharmaceuticals recently launching foscarnet sodium injection in the US. Market share and competition analysis highlight the presence of multiple players[2][3].
  • Europe: The European market is also substantial, with detailed analyses for countries such as Germany, France, the UK, Italy, and Spain. Market dynamics, including demand and consumption by type and application, are closely monitored[2].
  • APAC: This region shows promising growth, with countries like China, India, Japan, and South Korea contributing significantly to the market. The APAC market is driven by increasing demand for antiviral treatments[2].
  • South America and MEA: These regions also exhibit growth potential, with Brazil, Argentina, and South Africa being key markets. Macroeconomic analyses provide insights into the market trends and challenges in these regions[2].

Market Trends and Dynamics

The foscarnet sodium market is influenced by several factors, including the increasing prevalence of immunocompromised conditions, advancements in antiviral therapies, and regulatory approvals.

  • Porter's Five Forces Analysis: This analysis highlights the competitive landscape, bargaining power of suppliers and buyers, threat of new entrants, and the threat of substitute products[2].
  • PEST Analysis: Political, economic, social, and technological factors are considered to understand the broader market environment[2].

Market Projections

Forecast to 2029

Market reports project the foscarnet sodium market to grow over the next few years, driven by increasing demand for effective antiviral treatments.

  • Upstream Raw Materials and Downstream Demand: The analysis of upstream raw materials and downstream demand helps in understanding the supply chain dynamics and potential bottlenecks[3].
  • Regional Growth: The APAC region is expected to show significant growth due to the large patient population and increasing healthcare expenditure. Similarly, the North American and European markets are projected to maintain their dominance due to advanced healthcare infrastructure and high adoption rates of new therapies[2][3].

Key Players and Competition

The market is competitive with several key players, including Hikma Pharmaceuticals, Changzhou Sinly Pharmchem, and Jinan Chenghui Shuangda Chemical. These companies are involved in continuous research and development to improve the efficacy and safety of foscarnet sodium. SWOT analysis and financial figures of these companies provide insights into their market strategies and competitive positioning[2][3].

Challenges and Opportunities

Regulatory and Safety Challenges

Despite its efficacy, foscarnet sodium faces challenges related to its safety profile, including the risk of seizures and QT prolongation. Regulatory bodies closely monitor these aspects, and manufacturers must ensure compliance with safety guidelines[1].

Opportunities in Emerging Markets

Emerging markets in APAC and MEA regions offer significant opportunities for growth due to the increasing prevalence of HIV/AIDS and other immunocompromised conditions. Expanding healthcare infrastructure and growing awareness of antiviral treatments are driving factors in these regions[2][3].

Key Takeaways

  • Foscarnet sodium is a critical antiviral drug for treating CMV retinitis and acyclovir-resistant HSV infections.
  • Clinical trials have demonstrated its efficacy in delaying the progression of CMV retinitis.
  • The drug has a significant adverse event profile, including seizures and QT prolongation.
  • The global market is segmented into North America, Europe, APAC, South America, and MEA, with each region showing unique market dynamics.
  • Market projections indicate growth driven by increasing demand for antiviral treatments, particularly in the APAC region.
  • Key players are focusing on research and development to improve the drug's safety and efficacy.

Frequently Asked Questions (FAQs)

1. What are the primary indications for foscarnet sodium?

Foscarnet sodium is primarily indicated for the treatment of CMV retinitis in patients with AIDS and for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients[1].

2. What are the common adverse events associated with foscarnet sodium?

Common adverse events include fever, fatigue, rigors, and more severe events such as seizures, QT prolongation, and torsades de pointes[1].

3. Can foscarnet sodium be used in combination with other antiviral drugs?

Yes, foscarnet sodium can be used in combination with other antiviral drugs like ganciclovir, but it should be avoided with agents known to prolong the QT interval[1].

4. What regions are expected to drive the growth of the foscarnet sodium market?

The APAC region, along with North America and Europe, is expected to drive the growth of the foscarnet sodium market due to increasing demand for antiviral treatments and advanced healthcare infrastructure[2][3].

5. Are there any ongoing clinical trials for foscarnet sodium?

While the primary clinical trials have been completed, ongoing research and development focus on improving the drug's safety and efficacy, and there may be studies evaluating its use in combination with other therapies or in different patient populations[4].

Cited Sources:

  1. Hikma Pharmaceuticals PLC. "Hikma launches Foscarnet Sodium Injection in the US." September 23, 2024.
  2. Market Reports World. "Foscarnet Sodium Market Global Review and Outlook by 8 Companies."
  3. Prof Research. "Foscamet Sodium Market Size, Share, Trend and Forecast to 2025."
  4. Synapse. "Foscarnet Sodium - Drug Targets, Indications, Patents."
  5. Baxter PI. "Foscarnet Sodium Injection." November 2022.

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