IL-23 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

Interleukins are a group of immunomodulatory proteins- cytokines that are secreted by the leukocytes and some other body cells. There are many types of interleukins in the body that perform diverse functions and are responsible for many physiological functions with a significant role in regulating the immune response in the body. IL-23 is a member of the IL-12 family of cytokines. It has a function in innate and adaptive immunity modulation. One primary function of IL-23 is the development and differentiation of effector Th17 cells. IL-23 is produced by the macrophages and dendritic cells and is activated when the body encounters any bacterial infection.  It then activates Th17 and other IL-17-producing cells, such as CD8+ T cells. It has been seen to have a relationship with many types of diseases like gastritis,  colitis, arthritis, and psoriasis. It binds with the IL-23 receptor to elicit its responses which are expressed mostly in T-cells, NK (Natural killer) cells, monocytes/macrophages, and others. IL-23 has a significant role to play in the pathogenesis of the above diseases and is, therefore, a target for medicines. IL-23 can help reduce the inflammatory symptoms associated with many diseases, such as Rheumatoid Arthritis (RA), by blocking the IL-23 receptor. Research is being conducted globally to discover new and novel molecules to be used as anti-IL-23 agents. The development and launch of new products will thus increase the revenue of the market in the forecasted years.

Several of these inhibitors are on the market, while many are in ongoing clinical trials. 35 companies have various products in their pipelines, with 24 products in various stages of clinical trials. 1 product in Phase 4, 10 products in Phase 3, 7 products in Phase 2, and 5 products in Phase 1 of the clinical trials.

Key Developments of IL-23 Inhibitors

• In November 2022, Skyrizi (rizankizumab-rzaa) was approved by the European Commission (EU) for treating adults with moderate to severe Active Crohn’s disease.
• In June 2022, Skyrizi (rizankizumab-rzaa) was approved by the FDA as the 1^st and only for treating adults with moderate to severe Active Crohn’s disease.
• In January 2022, Skyrizi (rizankizumab-rzaa) was approved by the FDA for the treatment of adults with Active Psoriatic Arthritis.
• In July 2020, Tremfya (guselkumab) became the 1^st IL-23 Inhibitor approved by the FDA for patients with active psoriatic arthritis.
• In September 2018, Ilumya (tildrakizumab-asmn) was approved by the European Medical Agency (EMA) for the treatment of adults with moderate to severe plaque psoriasis.
• In April 2018, Tremfya (guselkumab) was approved by the MHRA of Japan for treating psoriatic arthritis.
• In September 2018, Ilumya (tildrakizumab-asmn) was approved by FDA for the treatment of adults with moderate to severe plaque psoriasis.

Approved molecules of IL-23 Inhibitors

• Tremfya (guselkumab)
• Ilumya (tildrakizumab-asmn)
• Skyrizi (rizankizumab-rzaa)
• Stelara (ustekinumab)

Drugs in the Pipeline of IL-23 Inhibitors

• Ozespa (briakinumab)
• brazikumab (AMG 139)
• apilimod (STA-5326)
• VB-201
• golimumab/guselkumab (JNJ-4804)
• apilimod dimesylate (AIT-101)
• ebdarokimab (AK101)
• VTX958
• ABP 654 (ustekinumab biosimilar)
• AVT04 (ustekinumab biosimilar)
• BAT2206 (ustekinumab biosimilar)
• CT-P43 (ustekinumab biosimilar)
• SB17 (ustekinumab biosimilar)
• AN2898
• BFI-751 (ustekinumab biosimilar)
• Bmab1200 (ustekinumab biosimilar)
• DMB-3115 (ustekinumab biosimilar)
• FYB202 (ustekinumab biosimilar)
• LY2525623
• NBL-012
• NeuLara (ustekinumab biosimilar)
• PF-07261271
• RT-111 (ustekinumab biosimilar)

Clinical Activity and Developments of IL-23 Inhibitors

As of June 2023, 35 companies have approximately 24 IL-23 Inhibitors for 36 diseases. For these diseases, 67 trials are being conducted by the players globally. For instance,

• In December 2022, Leo Pharma completed a Phase 4 clinical trial to study the efficacy and safety of Brodalumab compared to Guselkumab in the treatment of Plaque psoriasis after inadequate response to Ustekinumab.
• In November 2022, AbbVie completed a Phase 3 clinical trial to study the safety and efficacy of Risankizumab in adult patients with Plaque Psoriasis who have had a suboptimal response to secuniumab or ixekizumab.
• In July 2021, AbbVie completed a Phase 3 clinical trial to assess the efficacy of Rizanikumab compared to Secukinumab for the treatment of adult subjects with moderate to severe Plaque Psoriasis who are candidates for systemic therapy.