Fusion inhibitors are a class of antiviral drugs designed to combat viral infections by targeting the fusion process of viral particles with host cells. These inhibitors interact with specific receptors or molecules involved in the fusion step of viral entry. By doing so, they prevent the virus from fusing with the host cell membrane and entering the cell, thereby halting the infection at its initial stage. One of the most well-known applications of fusion inhibitors is in treating HIV/AIDS. HIV fusion inhibitors, like enfuvirtide, block the fusion of the virus with the host CD4+ T cells, reducing viral replication and slowing disease progression. Additionally, fusion inhibitors are under investigation for other viral infections, such as respiratory syncytial virus (RSV) and herpesvirus, showing the potential to inhibit viral entry and replication. According to the World Health Organization (WHO), HIV/AIDS remains a major global health issue, with approximately 38 million people living with HIV worldwide. In this context, fusion inhibitors offer a critical line of defense in antiretroviral therapy, providing hope for improved outcomes and quality of life for HIV-positive individuals. As research advances, fusion inhibitors may continue to be a valuable tool in the fight against various viral diseases, offering innovative treatment options and contributing to global efforts to combat infectious diseases. Extensive research is being conducted globally to discover new and novel molecules to be used, like palivizumab, that is used for the treatment of many indications like Respiratory tract diseases. The development and launch of new products will thus increase the market's revenue in the forecasted years.
Several of these inhibitors are on the market, while many are in ongoing clinical trials. Various companies have various products in their pipelines, with 14 products in various stages of clinical trials – 1 in Phase 4, 2 in Phase 3, 5 in Phase 2, and 1 in Phase 1 of the clinical trials.
Key Development of Fusion Inhibitors
- In December 2022, National Medical Products Administration (NMPA) accepted Ark Biopharmaceuticals’s Ziresovir (AK0529) for priority review of NDA for the treatment of RSV infection.
Approved Fusion Inhibitors molecules
- Synagis (palivizumab)
Drugs in the Pipeline of Fusion Inhibitors
- EDP-938
- ziresovir (AK0529)
- gontivimab (ALX-0171)
- presatovir (GS-5806)
- clesrovimab (MK-1654)
- MDT-637
- MB05 (palivizumab biosimilar)
- TNM001
Clinical Activity and Developments of Fusion Inhibitors
As of July 2023, various companies have approximately 14 products for 119 diseases. For these diseases, many trials are being conducted by players globally. For instance,
- Merck (MSD) is conducting a Phase 3 clinical trial to evaluate the safety, efficacy, and pharmacokinetics of Clesrovimab (MK-1654) in infants and children at increased risk for severe RSV disease that is expected to complete by April 2028.
- Enanta Pharmaceuticals is conducting a Phase 2 clinical trial to evaluate the effects of EDP-938 in Hematopoietic Cell Transplant recipients with Acute Respiratory Syncytial Virus infection of the Upper Respiratory Tract that is estimated to complete by April 2024.
- Enanta Pharmaceuticals is conducting a Phase 2 clinical trial to Evaluate the efficacy and safety of EDP-938 in non-hospitalized adults with Acute Respiratory Syncytial Virus infection who are at high risk for complications that is expected to complete by April 2024.
|
Molecule name |
Number of studies |
|
Synagis (palivizumab) |
33 |
|
EDP-938 |
11 |
|
ziresovir (AK0529) |
9 |
|
gontivimab (ALX-0171) |
7 |
|
gontivimab (ALX-0171) |
7 |
Target Indication Analysis of Fusion Inhibitors
Fusion inhibitors have shown significant promise in the treatment of various viral infections, with some indications standing out as particularly impactful. The most prominent application of fusion inhibitors is in managing HIV/AIDS. Enfuvirtide, an HIV fusion inhibitor, is crucial in preventing viral entry into host CD4+ T cells, effectively suppressing viral replication and disease progression. Additionally, fusion inhibitors are explored for their potential in combating respiratory syncytial virus (RSV) infections, a leading cause of severe respiratory illness in infants and older adults. Herpesvirus infections, including herpes simplex virus (HSV) and varicella-zoster virus (VZV), are other areas where fusion inhibitors are being investigated to inhibit viral entry and reduce symptoms. Furthermore, fusion inhibitors show promise in potential future applications against emerging viral threats, such as novel coronaviruses, offering a unique approach to combat these infectious diseases. Continued research and development in fusion inhibitors hold tremendous potential in revolutionizing antiviral therapy and enhancing global public health efforts.
Fusion Inhibitors Regional Analysis
Fusion Inhibitors Market
AstraZeneca’s global net sales of Synagis (palivizumab) in fiscal year 2022 were $578 million, 41% higher than global net sales in fiscal year 2021. Synagis made a net revenue of $1 million from the USA while a net income of $213 million from the European region in the same financial year with a growth of 5%. The global net revenue in the 4th quarter was $194 million, with a 19% decrease compared to the revenue in the 4th quarter of 2021. Synagis’s sales decreased in every region, i.e., USA, Europe, and the Rest of the World in the 4th quarter of 2022. According to the WHO report, approximately 39 million were living with HIV-AIDS at the end of 2022 globally. From these, 37.5 million adults are living with HIV, while 1.2 million are acquiring it, which is less as compared to 1.5 million adults developing it globally in 2021.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Synagis (palivizumab) have been approved by the FDA as a Fusion Inhibitor.
These are used for the treatment of diseases caused by various viruses like HIV, RSV, VZV, HSV and acute coronary syndrome, and others.
AbbVie, AstraZeneca, SOBI, Enanta Pharmaceuticals, and Ark Biosciences are some of the major market players for Fusion Inhibitors.
Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and rising incidence of various types of HIV and COVID and others are the key opportunities for Fusion Inhibitors in the market.
- AbbVie
- AstraZeneca
- SOBI
- Enanta Pharmaceuticals
- Ark Biosciences
- Sanofi
- Gilead Sciences
- Merck (MSD)
- Grupo Insud
- Guangzhou Biotechnology