CLINICAL TRIALS PROFILE FOR RELENZA

All Clinical Trials for Relenza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00784784 ↗	Zanamivir Versus Trivalent Split Virus Influenza Vaccine	Completed	GlaxoSmithKline	Phase 3	2008-11-01	This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers. The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.
NCT00784784 ↗	Zanamivir Versus Trivalent Split Virus Influenza Vaccine	Completed	Mount Sinai Hospital, Canada	Phase 3	2008-11-01	This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers. The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.
NCT00867139 ↗	TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients	Completed	Fred Hutchinson Cancer Research Center	Phase 1/Phase 2	2009-03-01	The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD
NCT00921726 ↗	Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 1	2009-07-01	Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.
NCT00921726 ↗	Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2009-07-01	Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.
NCT00979667 ↗	A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection	Terminated	Food and Health Bureau, Hong Kong	Phase 3	2009-10-01	To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.

Clinical Trial Conditions for Relenza

Condition Name

Condition Name for Relenza
Intervention	Trials
Influenza	5
Influenza, Human	5
Respiratory Disease	1
Sinusitis	1

Condition MeSH

Condition MeSH for Relenza
Intervention	Trials
Influenza, Human	8
Lung Diseases	1
Infection	1
Chronic Disease	1

Clinical Trial Locations for Relenza

Trials by Country

Trials by Country for Relenza
Location	Trials
United States	26
China	8
Canada	5
Australia	5
Germany	4

Trials by US State

Trials by US State for Relenza
Location	Trials
North Carolina	1
New York	1
Nevada	1
Montana	1
Missouri	1

Clinical Trial Progress for Relenza

Clinical Trial Phase

Clinical Trial Phase for Relenza
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Relenza
Clinical Trial Phase	Trials
Completed	7
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for Relenza

Sponsor Name

Sponsor Name for Relenza
Sponsor	Trials
GlaxoSmithKline	5
Food and Health Bureau, Hong Kong	1
Hospital Authority	1

Sponsor Type

Sponsor Type for Relenza
Sponsor	Trials
Other	7
Industry	5
NIH	1

RELENZA (Zanamivir): Clinical Trials, Market Analysis, and Projections

Overview of RELENZA

RELENZA, known generically as zanamivir, is an antiviral medication used for the treatment and prophylaxis of influenza A and B. It is administered via inhalation and works by inhibiting the neuraminidase enzyme on the surface of influenza viruses, preventing the viruses from spreading.

Clinical Trials and Efficacy

Treatment Trials

Clinical trials for RELENZA have been extensive, particularly in the context of treating influenza. Here are some key findings:

• Adverse Events: In Phase 3 treatment trials, common adverse events included headaches, diarrhea, nausea, vomiting, and respiratory symptoms such as nasal signs and symptoms, bronchitis, and cough. These events were generally mild to moderate and occurred at similar frequencies in both the zanamivir and placebo groups[3].
• Pediatric Subjects: In trials involving children aged 5 to 12 years, adverse events such as ear, nose, and throat infections, vomiting, diarrhea, and cough were reported. The incidence of these events was similar between the RELENZA and placebo groups[3].
• Prophylaxis Trials: In prophylaxis trials, RELENZA was administered to prevent influenza. Adverse events included viral respiratory infections, cough, headaches, and nasal signs and symptoms. These events were also generally mild to moderate[3].

Recent Studies

Recent studies have further evaluated the efficacy of antivirals, including RELENZA, in preventing and treating influenza. A systematic review involving eight trials with 1,424 participants found that antivirals like oseltamivir, peramivir, zanamivir, and baloxavir may shorten hospital stays and decrease the severity of influenza complications. However, the review also highlighted the need for more randomized controlled trials to fill knowledge gaps, especially regarding combination antiviral treatments and post-exposure prophylaxis[4].

Market Analysis

Global Influenza Treatment Market

The global influenza treatment market, within which RELENZA operates, is significant and growing.

• Market Size: As of 2023, the global influenza treatment market was estimated at USD 5.91 billion and is expected to grow at a CAGR of 1.18% from 2024 to 2030[5].
• Regional Dominance: North America dominates the market with a revenue share of 41.49% in 2023, driven by a well-established healthcare system, a growing population exposed to respiratory illnesses, and high hospitalization rates due to seasonal flu[5].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, offer lucrative opportunities for anti-influenza treatment providers.

• Growth Drivers: The growth in these regions is driven by an increasing elderly population prone to respiratory conditions, improved healthcare infrastructure, and enhanced influenza surveillance. The Asia-Pacific region is expected to show the fastest growth over the forecast period[5][2].

Market Projections

Revenue Forecast

• Global Forecast: The global influenza treatment market is projected to grow from USD 5.91 billion in 2023 to a higher figure by 2030, driven by factors such as emerging seasonal flu, increased prevalence of contagious respiratory illnesses, and growing patient populations at greater risk for seasonal flu-related complications[5].

Regional Growth

• North America: This region is expected to continue its dominance due to well-established healthcare facilities and a high incidence of seasonal flu.
• Asia-Pacific: This region is anticipated to show the fastest growth due to an aging population, improved healthcare infrastructure, and increased requirements for influenza drugs[5].

Key Players and Innovations

Novel Therapeutics

Key players in the market, including those developing RELENZA, are focusing on creating novel therapeutics to address the rising prevalence of influenza. For example, Genentech received approval for Xofluza (baloxavir) in August 2022, which is another antiviral used in the treatment of uncomplicated acute influenza[5].

Challenges and Future Directions

Knowledge Gaps

Despite the efficacy of antivirals like RELENZA, there are still significant knowledge gaps. Experts like David Hui emphasize the need for more randomized controlled trials to understand the role of antivirals in preventing and treating severe and non-severe influenza, as well as the potential benefits of combination antiviral treatments and immunomodulators[4].

Ongoing Trials

Ongoing and large-scale multicentre randomized controlled trials, such as the REMAP-CAP and RECOVERY trial platforms, are expected to provide answers to some of these gaps in the near future[4].

Key Takeaways

• Clinical Efficacy: RELENZA has been shown to be effective in treating and preventing influenza, with a manageable side effect profile.
• Market Growth: The global influenza treatment market is growing, driven by increasing prevalence of seasonal flu and improvements in healthcare infrastructure.
• Regional Opportunities: North America and the Asia-Pacific region offer significant market opportunities due to their large patient populations and well-established or improving healthcare systems.
• Future Directions: Ongoing clinical trials are expected to fill knowledge gaps and potentially lead to new treatment strategies, including combination therapies.

FAQs

What is RELENZA used for?

RELENZA (zanamivir) is used for the treatment and prophylaxis of influenza A and B.

What are the common side effects of RELENZA?

Common side effects include headaches, diarrhea, nausea, vomiting, and respiratory symptoms such as nasal signs and symptoms, bronchitis, and cough.

How is RELENZA administered?

RELENZA is administered via inhalation.

What is the current market size of the global influenza treatment market?

As of 2023, the global influenza treatment market was estimated at USD 5.91 billion.

Which regions are expected to show the fastest growth in the influenza treatment market?

The Asia-Pacific region is expected to show the fastest growth over the forecast period due to an aging population, improved healthcare infrastructure, and increased requirements for influenza drugs.

Sources

1. INTREPID Alliance - Antiviral Pipeline - INTREPID Alliance
2. Straits Research - Influenza Treatment Market Size, Global Trends, Demand, Forecast
3. GSK Pro - Relenza (zanamivir inhalation powder)
4. CIDRAP - 3 new studies probe the efficacy of antivirals in preventing, treating flu
5. Grand View Research - Influenza Treatment Market Size And Share Report, 2030