CLINICAL TRIALS PROFILE FOR TAMIFLU

All Clinical Trials for Tamiflu

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.
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	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.
NCT00304434 ↗	Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies.	Completed	Brooke Army Medical Center	Phase 4	2005-02-01	Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults.
NCT00304434 ↗	Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies.	Completed	National Institutes of Health (NIH)	Phase 4	2005-02-01	Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults.
NCT00304434 ↗	Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies.	Completed	US Department of Veterans Affairs	Phase 4	2005-02-01	Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults.

Clinical Trial Conditions for Tamiflu

Condition Name

Condition Name for Tamiflu
Intervention	Trials
Influenza	45
Healthy	4
Healthy Volunteer	4
Influenza, Human	4

Condition MeSH

Condition MeSH for Tamiflu
Intervention	Trials
Influenza, Human	49
Infections	7
Infection	5
Respiratory Tract Infections	5

Clinical Trial Locations for Tamiflu

Trials by Country

Trials by Country for Tamiflu
Location	Trials
United States	303
Canada	41
Australia	19
Spain	17
Italy	15

Trials by US State

Trials by US State for Tamiflu
Location	Trials
California	15
New York	14
Texas	14
Pennsylvania	13
Florida	13

Clinical Trial Progress for Tamiflu

Clinical Trial Phase

Clinical Trial Phase for Tamiflu
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	9
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Tamiflu
Clinical Trial Phase	Trials
Completed	49
Terminated	8
Withdrawn	6

Clinical Trial Sponsors for Tamiflu

Sponsor Name

Sponsor Name for Tamiflu
Sponsor	Trials
Hoffmann-La Roche	24
National Institute of Allergy and Infectious Diseases (NIAID)	7
University of Oxford	5

Sponsor Type

Sponsor Type for Tamiflu
Sponsor	Trials
Other	52
Industry	42
NIH	11

Tamiflu (Oseltamivir Phosphate): Clinical Trials, Market Analysis, and Projections

Introduction to Tamiflu

Tamiflu, also known as oseltamivir phosphate, is an antiviral medication widely used to treat and prevent influenza A and B infections. Here, we will delve into the latest clinical trials, market analysis, and projections for this critical drug.

Clinical Trials and Recent Developments

RECOVERY Trial Expansion

The RECOVERY trial, renowned for its role in identifying effective treatments for COVID-19, has recently expanded to investigate treatments for influenza. This trial aims to evaluate the efficacy of several antiviral medications, including oseltamivir (Tamiflu), baloxavir marboxil (Xofluza), and low-dose corticosteroids, in hospitalized patients with influenza. This expansion is significant because, despite the annual impact of influenza, few large-scale clinical trials have previously assessed treatments for severe influenza cases[1].

Transparency and Data Access

A notable campaign by The BMJ highlighted the importance of transparency in clinical trial data. The campaign led to the release of full clinical study reports for Tamiflu, which were previously unpublished. This transparency effort revealed discrepancies between published journal articles and the underlying trial data, raising questions about the drug's efficacy and safety profile. The Cochrane review based on these reports found no convincing evidence that Tamiflu affects influenza complications or infections, and it also raised concerns about the drug's harms profile[4].

Market Analysis

Global Market Size and Growth

The global Tamiflu market is projected to experience steady growth over the coming years. According to Transparency Market Research, the market was valued at $1.9 billion in 2023 and is expected to grow at a CAGR of 3.3% from 2024 to 2034, reaching $2.7 billion by 2034. This growth is driven by the rising incidence of seasonal influenza, increasing awareness of antiviral treatments, and innovations in drug formulations[3].

Regional Market Dynamics

• North America: This region holds the largest market share, driven by robust healthcare infrastructure and high awareness of antiviral treatments. The U.S. dominates this market due to seasonal flu outbreaks and strategic government stockpiling[3].
• Asia Pacific: This region is the fastest-growing market, with a CAGR of 7% from 2024 to 2031. Factors such as rapid urbanization, population growth, rising healthcare expenditure, and improving access to healthcare services contribute to this growth[2].
• Europe: The European market is expected to grow at a CAGR of 3.5% from 2024 to 2031, driven by similar factors as North America, including strong healthcare infrastructure and increasing awareness of antiviral treatments[2].
• Latin America and Middle East & Africa: These regions are also expected to see growth, albeit at lower CAGRs of 4.4% and 4.7%, respectively, due to increasing healthcare expenditure and improving access to antiviral medications[2].

Key Market Trends

Rising Influenza Incidence and Hospital Admissions

The global increase in influenza cases and subsequent hospital admissions have heightened the demand for antiviral drugs like Tamiflu. Health authorities are implementing stringent flu control programs and encouraging antiviral use to manage outbreaks[3].

Advancements in Tamiflu Formulations

Recent innovations, such as oral suspensions and pediatric-friendly dosage options, have broadened the drug’s accessibility. For example, the FDA-approved oral suspension launched by Strides Pharma Science Limited in 2022 has enhanced treatment for pediatric influenza patients[3].

Strategic Collaborations

Collaborations between major pharmaceutical players, such as Sanofi and Roche, are enhancing distribution networks and expanding the market reach of Tamiflu. These partnerships have significantly impacted market dynamics by ensuring robust supply chains and expanding over-the-counter availability[3].

Integration into Pandemic Preparedness Plans

Governments and health institutions are stockpiling antivirals like Tamiflu as part of their pandemic preparedness strategies. This stockpiling underscores the critical role of Tamiflu in mitigating influenza outbreaks[3].

Challenges in the Market

Cost Sensitivity

High costs of branded Tamiflu versions can limit adoption in low-income regions. The proliferation of generic Tamiflu offerings, especially in cost-sensitive regions like Asia Pacific and Latin America, is helping to address this issue but also intensifies market competition and impacts profit margins for branded Tamiflu[3].

Generic Competition

The increasing availability of generic Tamiflu is boosting accessibility but also intensifying market competition. This competition can reduce profit margins for branded versions of the drug[3].

Regulatory Hurdles

Variability in approval timelines across regions can delay product launches and accessibility. Regulatory approvals for advanced formulations, however, enhance accessibility and reinforce confidence in the drug's efficacy[3].

Projections and Future Outlook

Market Size Projections

By 2034, the global Tamiflu market is projected to reach $2.7 billion, driven by the factors mentioned above. The Asia Pacific region is expected to continue its rapid growth, while North America and Europe will maintain their significant market shares[3].

Emerging Trends

The future of the Tamiflu market will be shaped by ongoing innovations in drug formulations, strategic partnerships among pharmaceutical companies, and the integration of antivirals into pandemic preparedness plans. Increasing awareness and early diagnosis of influenza will also play crucial roles in driving market growth[3].

Key Takeaways

• Clinical Trials: The RECOVERY trial's expansion to include influenza treatments marks a significant step in evaluating the efficacy of antiviral medications like Tamiflu.
• Market Growth: The global Tamiflu market is expected to grow steadily, driven by rising influenza cases, innovations in drug formulations, and strategic collaborations.
• Regional Dynamics: Asia Pacific is the fastest-growing region, while North America and Europe maintain significant market shares.
• Challenges: Cost sensitivity, generic competition, and regulatory hurdles are key challenges facing the market.
• Future Outlook: The market will be shaped by ongoing innovations, partnerships, and the integration of antivirals into pandemic preparedness plans.

FAQs

What is the current global market size of Tamiflu?

The global Tamiflu market was valued at $1.9 billion in 2023[3].

What is the projected growth rate of the Tamiflu market from 2024 to 2034?

The market is expected to grow at a CAGR of 3.3% from 2024 to 2034[3].

Which region is the fastest-growing market for Tamiflu?

The Asia Pacific region is the fastest-growing market, with a CAGR of 7% from 2024 to 2031[2].

What are the key factors driving the growth of the Tamiflu market?

Key factors include the rising incidence of influenza, advancements in drug formulations, strategic collaborations, and the integration of antivirals into pandemic preparedness plans[3].

What challenges does the Tamiflu market face?

The market faces challenges such as cost sensitivity, generic competition, and regulatory hurdles[3].

Sources

1. University of Oxford: "World-leading RECOVERY trial expands to investigate treatments for influenza (flu)" - October 30, 2023.
2. Cognitive Market Research: "Tamiflu oseltamivir drug market will Grow at a CAGR of 5.00% from 2024 to 2031" - May 15, 2024.
3. Transparency Market Research Inc.: "Tamiflu (Oseltamivir Phosphate) Market Set to Surpass $2.7 Billion by 2034" - December 11, 2024.
4. The BMJ: "Tamiflu campaign" - The BMJ's open data campaign.
5. Valuates Reports: "Global Tamiflu (Oseltamivir Phosphate) Market Research Report 2024" - 2024.