Dengue – Pipeline Review, 2024

Dengue fever refers to a mosquito-borne viral illness that is caused by any of the four different but related viruses: dengue 1, dengue 2, dengue 3, and dengue 4. In many cases of the patients suffering from dengue, the symptoms are often mild or not noticeable. However, in some of the cases of dengue, the symptoms may be severe and in certain rare instances, may also lead to death. Dengue typically occurs in the tropical and the sub-tropical regions, and especially in the urban and semi-urban areas. Some of the symptoms associated with dengue includes:

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  • High Fever (40°C/104°F)
  
  
  • Severe Headache
  
  
  • Muscle and Joint Pain
  
  
  • Others
  
  
  
  

Epidemiology:

The dengue virus is transmitted to the humans generally through the bite of the infected female mosquitos, with the type of mosquito being the Aedes aegypti mosquito. In the recent decades, several epidemiological studies have observed that the number of cases of dengue has surged dramatically across the globe.

As of the data published by the World Health Organization (WHO) in May 2024, more than 7.6 million cases of dengue have been reported to the WHO. This includes 3.4 million cases that are confirmed, and over 16,000 severe cases and more than 3,000 deaths. While this rapid growth in the number of cases have been noted globally, the increase in the number of cases is particularly striking in the Region of the Americas.

Therapeutic Assessment:

The diagnosis of dengue is generally conducted through a blood test, while the healthcare professionals also take into consideration, the other factors such as travel history, the patient’s place of residence, travel notices by health agencies such as the Centers for Disease Control and Prevention (CDC), and records of vaccination. In terms of the medications used for the management of dengue, there exists prophylaxis medications, and also medications for the treatment of symptoms. According to the WHO, some of the commercially approved dengue vaccines available are Dengvaxia (CYD-TDV) by Sanofi and QDENGA by the Takeda Pharmaceutical Company Limited. After, dengue is contracted, it is generally treated at home with the administration of acetaminophen (paracetamol) therapy for the treatment of the fever and pain.

Key Products:

In terms of vaccines, some of the key products present in the market is Dengvaxia (CYD-TDV) by Sanofi and QDENGA by the Takeda Pharmaceutical Company Limited. While QDENGA is approved by the regulatory agencies in the countries/regions such as the U.K., Europe, Brazil, Indonesia, Thailand, and Argentina, while QDENGA is approved by the U.S. FDA. Some of the brands for acetaminophen (paracetamol) used for the dengue includes Tylenol, Feverall, Acephen, and Mapap.

Major Players in Dengue:

In terms of the vaccines approved for dengue, the major players are Sanofi and Takeda Pharmaceutical Company Limited. For acetaminophen (paracetamol), the major players are Johnson & Johnson Services, Inc., Taro Pharmaceutical Industries Ltd., GSK plc, and other prominent players.

Dengue Treatment Market Overview:

Dengue predominantly occurs in the tropical regions across the world, and these regions have a substantial patient burden. As dengue can be prevented through the utilization of effective vaccines, major biopharmaceutical firms are increasingly foraying into the development of dengue vaccines. Furthermore, some of the companies are focusing on the development of novel treatment for dengue. For instance, the dengue vaccine of QDENGA by the Takeda Pharmaceutical Company Limited generated sales of USD 66.7 million for the quarter ended June 30^th, 2024.

Pipeline Analysis:

Overview of the Pipeline:

Almost all of the active pipeline candidates for dengue treatment are in Phase 1, Phase 2, and Phase 3 of the clinical trials process. More than 45% of the pipeline candidates for the dengue treatment market are under the Phase 2 of the clinical trials process.

Pipeline By Mechanism of Action:

In terms of the mechanism of actions of the upcoming drugs for dengue, several of the biopharmaceutical firms are focusing on the development of prophylactic vaccines to complement the other two approved vaccines for dengue. However, some of the key players of the pharmaceuticals market, Novartis and EMERGENT (Emergent BioSciences), are also emphasizing on the development of interventions for dengue. Some of the medications for dengue which includes vaccines and treatment, with novel mechanisms of action are as follows:

• Inhibition of NS4B: The prominent pipeline candidate of EYU688 by Novartis is a key example of an upcoming drug with this mechanism of action. This drug particularly stands out, as it is one of the few prospective medication for dengue that works towards the treatment of the viral infection. This innovative inhibitor undertakes the selective suppression of this dengue virus (DENV) by the targeting of the viral NS4B protein. Certain mode-of-action studies have demonstrated that this inhibitor functions at the step of viral RNA synthesis.


• Inhibition of Host Endoplasmic Reticulum-Resident α-glucosidase 1 and α-glucosidase 2 Enzymes: The drugs which exercise this mechanism of action, are called iminosugar antivirals. The mechanism of action of this antiviral agent against dengue is through the competitive inhibition of endoplasmic reticulum α-glucosidase I and II enzymes that results in the misfolding of the viral glycoproteins which leads to the decrease in the viral assembly/release or affect viral infectivity.

Pipeline By Route of Administration:

An overwhelming proportion of the key drugs currently under the clinical trials for dengue are being tested for oral administration. This is especially true for the medications that are being termed as treatment for dengue. Some of them include EYU688 by Novartis, JNJ-64281802 by Johnson & Johnson Services, Inc., and Fenretinide (ISLA101) by Island Pharmaceuticals.

Pipeline By Molecule Type:

In terms of the distribution of the pipeline by the molecule type, there has been a significant number of pipeline candidates for both: small molecules and biologics. As a number of players are developing vaccines for dengue, these are biologics. Similarly, a number of prominent biopharmaceutical companies are developing interventions for dengue. These are traditionally small molecule drugs.

Pipeline By Company:

In terms of key players engaged in the clinical trials for dengue, some of the prominent players are Novartis, Johnson & Johnson Services, Inc., Island Pharmaceuticals, EMERGENT (Emergent BioSciences), Butantan Institute, and others.

Clinical Trial Insights:

Ongoing Clinical Trials: Some of the key pipeline candidates under clinical trials are as follows:

Phase 1:

• AT-752: Atea Pharmaceuticals


• rDENdelta30/31-7164: National Institute of Allergy and Infectious Diseases (NIAID)


• AV-1: AbViro LLC


• INO-A002: University of Pennsylvania/ Inovio Pharmaceuticals


• UV-4B: EMERGENT (Emergent BioSciences)

Phase 2:

• V181: Butantan Institute


• EYU688: Novartis


• JNJ-64281802: Johnson & Johnson Services


• ISLA101: Island Pharmaceuticals

Phase 3:

• Dengue Tetravalent Vaccine (TDV) & Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV): Takeda Pharmaceutical Company

Future Trial Prospects:

• August 2024: Indian Council of Medical Research (ICMR) and Panacea Biotec announced the initiation of the first Phase 3 dengue vaccine clinical trial in India with the first ever indigenously developed dengue vaccine called DengiAll.


• June 2022: Novartis reaffirmed their commitment to the Kigali Declaration on neglected tropical diseases which includes dengue. This includes the continuation of the clinical trials for disease such as dengue. The company’s candidate of EYU688, whose lead indication is dengue, is currently in Phase 2 of clinical trials.

Regulatory Landscape:

• FDA and EMA Approvals: There has been no regulatory approval for dengue treatment medications by either the U.S. FDA or the European Medicines Agency (EMA). However, in terms of dengue vaccines, while the European Medicines Agency has approved a greater number of vaccines (Dengvaxia (CYD-TDV), and QDENGA), while the U.S. FDA has approved only one dengue vaccine (Dengvaxia (CYD-TDV).


• Orphan Drug Designations: Historically, certain drugs or compounds have received the regulatory designation of orphan drug designation (ODD) for the dengue treatment. For instance, in August 2013, the drug of DengueCide had received the ODD from the U.S. FDA for the treatment of dengue fever and dengue hemorrhagic fever. In recent times, such approvals have been lagging for dengue treatment.


• Market Authorization Challenges: Certain marketing authorization challenges that the companies’ engaged in the pipeline trials for dengue face are the stringent regulations of the submission of adequate data. For instance, Takeda Pharmaceutical Company announced the voluntary withdrawal of their regulatory approval application for their dengue vaccine candidate of TAK-003 (QDENGA) as the U.S. FDA asked for certain additional data for the approval of the vaccine.

Report Scope

• A thorough assessment of the pipeline products by areas such as development stage; route of administration; drug class; indication; sponsor; molecule type and drug target


• Comprehensive profiles of the pipeline products with details such as company overview; product description; R&D status; development activities; mechanism of action; molecule type; development stage; indications; funding and route of administration


• Overview of dormant and discontinued pipeline products


• Key insights about the epidemiology of conditions being treated by the pipeline products and overview of the addressable or current market for the pipeline products


• Overview of the latest developments; news articles, press releases, and relevant conferences

Report Methodology

• All pipeline reports are built through the analysis of data primarily collected through credible desk research sources. Secondary research is supplemented by interviews conducted with key opinion leaders.


• Desk research sources include global and regional clinical trials databases; annual reports, websites, press releases & investor presentations of companies; white papers; news articles; reports published by industry associations; articles/reports published on databases such as NCBI, ResearchGate; internal databases

Reasons to Buy this Report

• Develop effective growth strategies based on a comprehensive overview of the R&D activity and pipeline products for Dengue


• Identify emerging players or competition in the market based on pipeline products and develop strategies to counter the emergence of these players


• Identify the focus of leading players about R&D for Dengue


• Identify potential companies from a partnership or acquisition point of view based on current synergy in R&D activities or strategies to diversify R&D focus to drive growth in business


• Analyze the reasons behind dormant and discontinued products to make changes in the R&D focus if necessary