CLINICAL TRIALS PROFILE FOR RIMANTADINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Rimantadine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01413490 ↗	Hepatitis C Rimantadine and Antiviral Combination Therapy	Completed	Cancer Research UK		2012-05-01	Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus directly - their specific mode of action is confirmed by showing the virus is forced to adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.
New Combination	NCT01413490 ↗	Hepatitis C Rimantadine and Antiviral Combination Therapy	Completed	The Leeds Teaching Hospitals NHS Trust		2012-05-01	Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus directly - their specific mode of action is confirmed by showing the virus is forced to adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.

All Clinical Trials for Rimantadine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	University of Oxford	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	Wellcome Trust	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	World Health Organization	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.

Clinical Trial Conditions for Rimantadine Hydrochloride

Condition Name

Condition Name for Rimantadine Hydrochloride
Intervention	Trials
Influenza	3
Avian Influenza	1
Healthy Volunteer	1

Condition MeSH

Condition MeSH for Rimantadine Hydrochloride
Intervention	Trials
Influenza, Human	4
Respiratory Tract Infections	2
Infections	2

Clinical Trial Locations for Rimantadine Hydrochloride

Trials by Country

Trials by Country for Rimantadine Hydrochloride
Location	Trials
United States	21
Thailand	4
Argentina	2
Hong Kong	1
Vietnam	1

Trials by US State

Trials by US State for Rimantadine Hydrochloride
Location	Trials
Virginia	1
Texas	1
Tennessee	1
South Dakota	1
Pennsylvania	1

Clinical Trial Progress for Rimantadine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Rimantadine Hydrochloride
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Rimantadine Hydrochloride
Clinical Trial Phase	Trials
Completed	4
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for Rimantadine Hydrochloride

Sponsor Name

Sponsor Name for Rimantadine Hydrochloride
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
University of Oxford	2
Wellcome Trust	1

Sponsor Type

Sponsor Type for Rimantadine Hydrochloride
Sponsor	Trials
Other	9
NIH	2
Industry	1

Rimantadine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Rimantadine hydrochloride, known by the brand name Flumadine, is an antiviral drug used to treat and prevent influenza A virus infections. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Phases of Clinical Trials

Clinical trials for rimantadine hydrochloride, like other drugs, progress through several phases. Here’s a brief overview of the phases relevant to rimantadine:

• Phase I: This phase assesses the safety and dosage of the treatment in a small group of healthy volunteers or patients. For rimantadine, early trials focused on its pharmacokinetics and safety profile[1].
• Phase II: This phase expands the study to a larger group to further evaluate the safety and efficacy of the drug. Studies have shown that rimantadine significantly reduces nasal secretion viral titers, maximal temperature, and systemic symptoms in patients with influenza A H3N2 subtype virus infection[4].
• Phase III: This phase involves even larger populations to confirm the drug's safety, efficacy, and effectiveness compared to standard treatments. Rimantadine has been compared to placebo in several trials, demonstrating its efficacy in treating uncomplicated influenza A infections[4].
• Phase IV: Conducted after FDA approval, these trials gather additional information on the treatment's risks, benefits, and optimal use. There is ongoing monitoring of rimantadine's performance in real-world settings.

Key Findings from Clinical Trials

• A randomized, double-blind trial showed that rimantadine treatment (200 mg/day for 5 days) significantly reduced nasal secretion viral titers, maximal temperature, and systemic symptoms compared to placebo treatment in patients with influenza A H3N2 subtype virus infection[4].
• Clinical trials have also highlighted the drug's pharmacokinetics, including its absorption, peak plasma concentration, and elimination half-life. For example, the mean peak plasma concentration after a single 100 mg dose was 74 ± 22 ng/mL, with an elimination half-life of approximately 25 hours in healthy adults[1].

Pharmacokinetics and Safety Profile

Pharmacokinetics

Rimantadine hydrochloride is absorbed after oral administration, with a peak plasma concentration reached within 6 hours in healthy adults. The drug has a significant accumulation profile when administered twice daily, with steady-state concentrations achieved within 10 days[1].

Safety Profile

In clinical trials, the most frequently reported adverse events involved the gastrointestinal and nervous systems. These included events such as nausea, vomiting, and dizziness, occurring in 1% to 3% of patients treated with the recommended dose of 200 mg daily[1].

Special Populations

• Renal Impairment: Patients with severe renal impairment showed increased Cmax, Cmin, and AUC values, and a prolonged elimination half-life compared to healthy subjects[1].
• Hepatic Insufficiency: Caution is advised when treating patients with hepatic insufficiency due to the potential for accumulation of rimantadine and its metabolites in plasma[1].
• Elderly Patients: Steady-state concentrations in elderly nursing home patients were significantly higher than those in healthy young and elderly adults, indicating a need for dose adjustment in this population[1].

Market Analysis

Global Market Size

The global rimantadine hydrochloride market, while not as large as other pharmaceutical markets, is part of the broader antiviral drug market. The specific market size for rimantadine hydrochloride was valued at US$ million in 2023, though exact figures are not provided in the available sources[5].

Market Drivers

• Increasing Prevalence of Influenza: The ongoing need for effective treatments against influenza A virus infections drives the demand for rimantadine hydrochloride.
• Government Initiatives: Government funding and initiatives to support the development and distribution of antiviral drugs also contribute to market growth.

Market Segmentation

The market for rimantadine hydrochloride can be segmented based on application (treatment and prevention of influenza A), distribution channels (hospitals, pharmacies, online retailers), and geography (regional markets).

Market Projections

Growth Forecast

While specific growth projections for the rimantadine hydrochloride market are not detailed in the sources, the broader antiviral drug market is expected to grow due to increasing demand for effective treatments against viral infections.

Trends and Opportunities

• Emerging Markets: There is potential for growth in emerging markets where access to antiviral medications is increasing.
• Seasonal Demand: The demand for rimantadine hydrochloride is likely to be seasonal, peaking during influenza outbreaks.

Key Takeaways

• Clinical Efficacy: Rimantadine hydrochloride has been shown to be effective in treating and preventing influenza A virus infections through various clinical trials.
• Pharmacokinetics: The drug has a well-defined pharmacokinetic profile, with considerations needed for patients with renal impairment and hepatic insufficiency.
• Market Potential: The market for rimantadine hydrochloride is driven by the ongoing need for antiviral treatments and is expected to grow, albeit modestly, in the coming years.

FAQs

What is the primary use of rimantadine hydrochloride?

Rimantadine hydrochloride is primarily used to treat and prevent influenza A virus infections.

What are the common adverse effects of rimantadine hydrochloride?

Common adverse effects include gastrointestinal and nervous system issues such as nausea, vomiting, and dizziness.

How does rimantadine hydrochloride affect patients with renal impairment?

Patients with severe renal impairment show increased Cmax, Cmin, and AUC values, and a prolonged elimination half-life compared to healthy subjects.

Is rimantadine hydrochloride effective against all types of influenza?

Rimantadine hydrochloride is specifically effective against influenza A virus infections and has not been shown to be effective against influenza B or C.

What is the recommended dosage for rimantadine hydrochloride?

The recommended dosage is typically 200 mg daily, though this may need to be adjusted for certain patient populations such as the elderly or those with renal impairment.

Sources

1. Drugs.com - Rimantadine: Package Insert / Prescribing Information.
2. Market Research Reports - Global Rimantadine Hydrochloride Market Research Report 2024.
3. Straits Research - Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2025-2033.
4. PubMed - Oral rimantadine hydrochloride therapy of influenza A virus H3N2 subtype virus infection.
5. QY Research - Global Rimantadine Hydrochloride Market Research Report 2024.