CLINICAL TRIALS PROFILE FOR VIRAZOLE

All Clinical Trials for Virazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018031 ↗	Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2001-06-01	This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00446134 ↗	Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)	Completed	Bausch Health Americas, Inc.	Phase 2	2007-03-01	The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
NCT00446134 ↗	Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)	Completed	Valeant Pharmaceuticals International, Inc.	Phase 2	2007-03-01	The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
NCT00500578 ↗	Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	Completed	ICN Pharmaceuticals	Phase 4	2003-02-01	Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.

Clinical Trial Conditions for Virazole

Condition Name

Condition Name for Virazole
Intervention	Trials
Hepatitis C	3
Hepatitis C Infection	2
Thrombocytopenia	2
Chronic Hepatitis C	2

Condition MeSH

Condition MeSH for Virazole
Intervention	Trials
Hepatitis C	8
Hepatitis	8
Hepatitis A	6
Hepatitis C, Chronic	4

Clinical Trial Locations for Virazole

Trials by Country

Trials by Country for Virazole
Location	Trials
United States	8
Germany	2
Greece	2
France	1
Poland	1

Trials by US State

Trials by US State for Virazole
Location	Trials
California	3
Texas	2
New York	1
Virginia	1
Maryland	1

Clinical Trial Progress for Virazole

Clinical Trial Phase

Clinical Trial Phase for Virazole
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	5
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Virazole
Clinical Trial Phase	Trials
Completed	9
Terminated	2
Recruiting	1

Clinical Trial Sponsors for Virazole

Sponsor Name

Sponsor Name for Virazole
Sponsor	Trials
Bausch Health Americas, Inc.	4
M.D. Anderson Cancer Center	2
Merck Sharp & Dohme Corp.	2

Sponsor Type

Sponsor Type for Virazole
Sponsor	Trials
Industry	11
Other	6
U.S. Fed	3

VIRAZOLE: Clinical Trials, Market Analysis, and Projections

Introduction to VIRAZOLE

VIRAZOLE, known generically as Ribavirin, is a broad-spectrum antiviral medication that has been used to treat various viral infections, including Respiratory Syncytial Virus (RSV), hepatitis C, and some other viral diseases. Here, we will delve into the current clinical trials, market analysis, and future projections for VIRAZOLE.

Clinical Trials and Efficacy

VIRAZOLE in RSV Treatment

VIRAZOLE has been a cornerstone in the treatment of RSV infections, particularly in high-risk populations such as infants and the elderly. The drug is often administered as an aerosolized solution for direct lung delivery, which enhances its efficacy against RSV[2].

Recent market reports indicate that VIRAZOLE continues to be a significant player in the RSV therapeutics market. Despite the challenges in developing new RSV treatments, VIRAZOLE's broad-spectrum antiviral activity has maintained its relevance. For instance, the failure of many monoclonal antibody and vaccine candidates in late-stage clinical trials has kept VIRAZOLE as a viable option for treating RSV infections[3].

Ongoing and Future Clinical Trials

While there are no specific new clinical trials exclusively focused on VIRAZOLE mentioned in recent reports, the drug's inclusion in various treatment protocols for RSV and other viral infections continues. The development of new antiviral drugs and vaccines for RSV, however, may influence the future use and efficacy of VIRAZOLE in clinical settings.

Market Analysis

Market Size and Growth

The global antiviral drugs market, which includes VIRAZOLE, is projected to grow significantly. The market size for antiviral drugs is expected to reach USD 50.02 billion by 2030, with a CAGR of 3.4% during the forecast period from 2022 to 2030[5].

Segment Analysis

In the context of the RSV therapeutics market, VIRAZOLE falls under the antiviral medication segment. This segment is anticipated to grow at a CAGR of 15.9% from 2024 to 2032, driven by the increasing incidence of RSV infections and the need for effective treatments[2].

Distribution and Dosage Forms

VIRAZOLE's versatility in administration forms, including aerosolized solutions, contributes to its market growth. Injectables, which include some antiviral medications, dominate the market revenue, but the antiviral segment, where VIRAZOLE is categorized, is expected to grow faster due to its broad-spectrum activity and ease of administration[2].

Market Projections

Future Market Trends

The rising incidence of viral respiratory infections, including RSV, is a key driver for the growth of the antiviral drugs market. Factors such as increasing human mobility, trade, and tourism, as well as changing environmental conditions due to climate change, are expected to continue driving the demand for antiviral medications like VIRAZOLE[5].

Challenges and Opportunities

Despite the positive market projections, there are challenges to consider. High costs associated with research and development (R&D) in drug development can limit market growth. However, the lack of approved antiviral drugs and vaccines for RSV presents a significant opportunity for VIRAZOLE and other antiviral medications to fill this gap[3].

Regulatory and Competitive Landscape

VIRAZOLE benefits from its established presence in the market, but it faces competition from new vaccine candidates and therapeutic agents. For example, Pfizer's RSVpreF vaccine candidate and AstraZeneca's nirsevimab are in various stages of clinical trials and regulatory review, which could impact the market share of VIRAZOLE in the future[3].

Key Takeaways

• Clinical Efficacy: VIRAZOLE remains effective in treating RSV infections, particularly in high-risk populations.
• Market Growth: The antiviral drugs market, including VIRAZOLE, is projected to grow significantly, driven by the rising incidence of viral infections.
• Segment Analysis: The antiviral medication segment, where VIRAZOLE is categorized, is expected to grow at a high CAGR.
• Challenges and Opportunities: High R&D costs and competition from new treatments are challenges, but the unmet medical need for RSV treatments presents opportunities.
• Future Trends: Increasing global mobility and climate change will continue to drive the demand for antiviral medications.

FAQs

Q: What is VIRAZOLE used for?

VIRAZOLE, or Ribavirin, is used to treat various viral infections, including Respiratory Syncytial Virus (RSV), hepatitis C, and other viral diseases.

Q: How is VIRAZOLE administered for RSV treatment?

VIRAZOLE is often administered as an aerosolized solution for direct lung delivery to treat RSV infections.

Q: What is the projected market growth for antiviral drugs like VIRAZOLE?

The global antiviral drugs market is expected to reach USD 50.02 billion by 2030, with a CAGR of 3.4% from 2022 to 2030.

Q: What challenges does the development of new RSV treatments face?

The development of new RSV treatments faces challenges such as understanding the virus's pathogenesis, immune response, and potential therapeutic targets, as well as pipeline product failures in clinical trials.

Q: How does VIRAZOLE compare to new RSV vaccine candidates?

VIRAZOLE remains a viable treatment option due to its broad-spectrum antiviral activity, but new vaccine candidates like Pfizer's RSVpreF and AstraZeneca's nirsevimab may impact its market share in the future.

Sources

1. Liver Disease News: "Phase 3 trials of treatment combo for hepatitis D expected in 2025"
2. Astute Analytica: "Respiratory Syncytial Virus Market Size | Report 2032"
3. SNS Insider: "Respiratory Syncytial Virus [RSV] Therapeutics Market Share"
4. Veru Pharmaceuticals: "Veru Reaches Full Enrollment for Phase 2b QUALITY Clinical Study"
5. BioSpace: "Antiviral Drugs Market Analysis 2022-2030 - BioSpace"