Interleukin-21 (IL-21) Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Interleukin-21 (IL-21) is a potent cytokine belonging to the class of immunoregulatory molecules known as interleukins. It plays a crucial role in modulating the immune system and has garnered significant interest in medical research for its diverse immunomodulatory properties. IL-21 is mainly produced by activated CD4+ T cells and natural killer T cells, and it exerts its effects by binding to specific receptors on target cells, initiating a cascade of immune responses. IL-21 acts through a receptor complex composed of the IL-21 receptor (IL-21R) and the common gamma chain (γc), which is shared with other cytokines. Upon binding to its receptor complex, IL-21 activates the Janus kinase (JAK) and signal transducer and activator of the transcription (STAT) pathway, leading to the activation of various downstream signaling pathways, culminating in the regulation of immune cell functions. IL-21 holds therapeutic potential for multiple diseases. It is being explored in cancer immunotherapy, particularly in treating solid tumors and hematological malignancies, owing to its ability to enhance antitumor immune responses. According to the World Health Organization (WHO), cancer is one of the leading causes of death globally, with around 10 million deaths reported in 2020. IL-21's application in cancer research shows promising results in combatting this global health challenge. Extensive research is being conducted globally to discover new and novel molecules to be used, like Denenicokin, which is used to treat many indications like Autoimmune diseases. The development and launch of new products will thus increase the market's revenue in the forecasted years.

Many of these are in the market, while many are in ongoing clinical trials. 6 companies have 4 IL-21 Agonists in various stages of clinical trials – 1 in Phase 1 of the clinical trials, while 5 companies have 5 IL-21 Inhibitors in different stages of clinical trials – 3 products in Phase 2 and 2 in Phase 1 of the clinical trials  

Clinical Activity and Developments of Interleukin-21 (IL-21)
As of July 2023, 6 companies have approximately 4 IL-21 Agonists for various diseases, while 5 have approximately 5 IL-21 Inhibitors for 13 conditions. For these diseases, 3  and various trials, respectively, are being conducted by players globally. For instance,

  • Anwita Biosciences is conducting a Phase 1 clinical study of JS014, a recombinant fusion protein of Interleukin-21 and humanized anti-human serum Albumin VHH antibody as a single agent or in combination with Pembrolizumab in subjects with Advanced Cancer that is expected to complete by January 2025.
  • Hangzhou Converd Co., Ltd is conducting a phase1 clinical trial to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21 Oncolytic Vaccinia Virus Injection (hV01) in patients with Advanced Malignant Solid Tumors that are expected to complete by November 2025.
  • Amgen is conducting a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMG 256 in patients with Advanced Solid Tumors that is expected to complete by September 2023.

Drugs in the Pipeline of IL-21 Agonists

  • Denenicokin (BMS-982470)
  • JS014
  • HV01
  • Latikafusp (AMG 256)

Molecule name

Number of studies

denenicokin (BMS-982470)






latikafusp (AMG 256)



Drugs in the Pipeline of IL-21 Inhibitors

  • NN9828
  • Avizakimab (BOS161721)
  • ATR-107
  • LY3200327
  • Tofacitinib/fingolimod (FMX114)

Molecule name

Number of studies



avizakimab (BOS161721)






tofacitinib/fingolimod (FMX114)


Target Indication Analysis of Interleukin-21 (IL-21)

IL-21, a powerful immunoregulatory cytokine, has a broad range of indications in medical research, with some applications showing particular assurance. One of the most significant areas where IL-21 finds use is in cancer immunotherapy. It has been extensively studied for its potential to enhance the immune response against various cancers, including melanoma, renal cell carcinoma, and lymphoma. Additionally, IL-21 plays a crucial role in treating viral infections, such as chronic hepatitis B and C, by stimulating antiviral immune responses. The cytokine's immunomodulatory properties are also explored in autoimmune diseases like type 1 diabetes and systemic lupus erythematosus, which aims to restore immune balance. Furthermore, IL-21 is being investigated as an adjuvant for vaccines, aiming to improve the effectiveness of vaccination strategies against infectious diseases. As research into IL-21 continues, its versatile applications offer hope for innovative therapeutic approaches across multiple medical fields.

Frequently Asked Questions

Currently, no IL-21 Agonist and IL-21 Inhibitor have been approved by the FDA.

These are used to treat diseases caused by various diseases like autoimmune diseases including SLE, Crohn's disease, Rheumatoid Arthritis, Hepatitis B and C, and others.

BMS, Shanghai Junshi Bioscience, Anwita Bioscience, ConVerd Pharmaceuticals, and Amgen are major market players for IL-21.

Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and rising incidence of various diseases like SLE, Crohn's disease, Rheumatoid Arthritis, and others are the key opportunities for IL-21 in the market.

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  • BMS
  • Shanghai Junshi Bioscience
  • Anwita Bioscience
  • ConVerd Pharmaceuticals
  • Amgen
  • Novo Nordisk
  • Boston Pharma
  • Pfizer
  • Eli Lilly
  • Vyne Therapeutics

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