Interleukin 4 (IL-4 ) Market: Competitive Landscape, Pipeline, and Market Analysis 2023

IL-4 (Interleukin 4) is a cytokine secreted by various cells like the mast cells, Th2 cells, Eosinophils and Basophils. The effect of IL-4 is mediated via the IL-4 receptor alpha chain, which, upon activation by its ligand, dimerizes to produce either a Type-1 signaling complex or a Type-2 signaling complex. Type-2 expressed on the non-hemopoietic cells, like endothelial cells, responds to IL-4. Therefore, IL-4 functions as a potent regulator of immunity. IL-4 has been associated with the pathophysiology of allergy, hypersensitivity, and other immunological diseases. It is also related to the pathology of neurological disorders such as Alzheimer’s disease, Multiple Sclerosis, and Glioblastoma Multiforme, thus, it has a profound role in maintaining the brain’s immunity- memory and learning. Studies also say that IL-4 rescues B-cells from apoptosis and is responsible for Ig subtype switching to IgG1 and IgE. IL-4 along with IL-13, has been associated with the pathophysiology of many diseases Asthma, Atopic Dermatitis (AT), and others. Extensive research is being conducted globally to discover new and novel molecules to be used, like dupilumab which is used for the treatment of many indications like Atopic Dermatitis. The development and launch of new products will thus increase the market’s revenue in the forecasted years. For instance, according to a research article, the prevalence of Prurigo Nodularis (PN) in 2020 in the USA was estimated to be 72 per 100,000 adult people. Companies are trying to develop new molecules to target these indications, and many of them are being evaluated in clinical trials. For instance, Dupixent (dupilumab) is approved in the USA and Europe for treating Atopic Dermatitis e(AD).

A number of these inhibitors are in the market, while many are in ongoing clinical trials. Various companies have various products in their pipelines, with 6 products in various stages of clinical trials – 1 in Phase 4, 3 in Phase 3, 17 in Phase 2, and 7 in Phase 1 of the clinical trials.

Key Developments of IL-4

• In March 2023, the EU approved Dupixent (dupilumab) for children aged six months to 11 years with moderate-to-severe Atopic Dermatitis (AT).
• In January 2023, Dupixent (dupilumab) became the 1^st drug approved by the European Commission (EC) for treating adults and adolescents with Eosinophilic Esophagitis in Europe.
• In December 2022, Dupixent (dupilumab) became the 1^st drug approved by the European Commission for treating adult patients with moderate to severe Prurigo Nodularis, who are candidates for systemic therapy in Europe.
• In May 2022, Dupixent (dupilumab) was approved by the FDA for treating patients with Eosinophilic Esophagitis.
• In June 2022, FDA approved Dupixent (dupilumab) as the 1^st biologic for children aged six months to 5 years of age with moderate-to-severe Atopic Dermatitis (AT).
• In September 2020, Dupixent (dupilumab) was granted Breakthrough designation by the FDA for treating patients with Eosinophilic Esophagitis.
• In May 2020, the FDA approved Dupixent (dupilumab) as the 1st biologic for children aged 6 to 11 with moderate-to-severe Atopic Dermatitis (AT).
• In October 2018, the FDA approved Dupixent (dupilumab) for treating moderate-to-severe Aathma.

Approved IL-4 Molecules

• Dupixent (Dupilumab)

Drugs In The Pipeline Of IL-4

• CM310
• CBP-201
• Aerovant (Pitrakinra)
• Elarekibep (PRS-060)
• 611
• SHR-1819
• Eblasakimab (ASLAN004)
• AR100
• VAK694
• Bizaxofusp (MDNA55)
• Manfidokimab (AK120)
• Romilkimab (SAR156597)
• AIR645
• MG-K10
• REGN846
• AMG 317
• GR1802
• GSK2434735
• LQ036
• MEDI9314
• PF-07264660
• PF-07275315
• R256
• TQH2722
• Hypochlorous Acid (PR013)
• Hypochlorous Acid (PR022)

Clinical Activity and Developments of IL-4

As of July 2023, various companies have approximately 46 products for 96 diseases. For these diseases, many trials are being conducted by players globally. For instance,

• In November 2022, Regeneron Pharmaceuticals completed a Phase 3 clinical trial to assess the efficacy and safety of dupilumab on skin lesions in adult and adolescent patients with moderate-to-severe atopic hand and foot dermatitis.
• In December 2020, AbbVie completed a Phase 3 clinical trial comparing the safety and efficacy of Upadacitinib to Dupilumab in adult subjects with moderate-to-severe Atopic Dermatitis (AD).
• Keymed Biosciences Co. Ltd. is conducting a Phase 3 clinical trial to evaluate the efficacy and safety of CM310 recombinant humanized monoclonal antibody injection in patients with seasonal allergic rhinitis under background treatment that is expected to complete by July 2024.