Interleukin-12 (IL-12) Analogues Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Interleukin-12 (IL-12) is a heterodimeric cytokine with broad immunomodulatory properties that belongs to a larger family of proteins called IL-12-related cytokines. IL-12-related cytokines are produced by five independently regulated genes that homodimerize and heterodimerize to form seven secretory family members. These proteins have overlapping and distinct biological properties and are produced primarily by dendritic cells, monocytes, macrophages, and to a lesser extent, by B cells. It has been identified as an immune cell stimulant that promotes T cell differentiation and proliferation and increases interferon-gamma production. Therefore, they have been implicated in CD4 and CD8 T cell differentiation, host defense, autoimmunity, immune recognition of tumor cells, alloimmunization, and regulation of the host response to vaccination. Therefore, IL-12 functions as a potent regulator of immunity. IL-12 stimulates natural killer (NK) cells and T lymphocytes, promoting their proliferation and secretion of interferon-gamma, which enhances the cytotoxic response against pathogens and malignant cells. The nature of the adaptive immune response is regulated by the innate response to infection and influenced by IL-12 expression at that time. This powerful cytokine has therapeutic applications in various diseases, including certain cancers, chronic viral infections, and autoimmune disorders. In cancer immunotherapy, IL-12 has been utilized to bolster anti-tumor immunity by activating immune cells to target and destroy cancerous cells. However, due to its potent nature, precise dosing and targeted delivery are crucial to minimize potential adverse effects. Harnessing the therapeutic potential of IL-12 continues to hold great promise for advancing immunotherapies and improving patient outcomes in numerous debilitating conditions. Extensive research is being conducted globally to discover new and novel molecules, like ustekizumab, which treats many infections like Mycobacterium infections. 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 140 products in multiple stages of clinical trials – 1 in Phase 4, 11 in Phase 3, 3 in Phase 2, and 4 in Phase 1 of the clinical trials.

Approved Interleukin-12 (IL-12) Analogues

  • Stelara (ustekinumab)

Drugs in the Pipeline of Interleukin-12 (IL-12) Analogues

  • Rocakinogene Sifuplasmid (INO-9012)
  • PDS0301
  • Ozespa (Briakinumab)
  • Tavo (Tavokinogene Telsaplasmid)
  • Ad-RTS-Hil-12
  • IMNN-001
  • Apilimod (STA-5326)
  • MEDI0457
  • VB-201
  • Hemamax (Rhuil-12)
  • T3011
  • VG161
  • Trivax (AV0113)
  • Apilimod Dimesylate (AIT-101)
  • Ebdarokimab (AK101)
  • SON-1010
  • Urocidin (Mycobacterium Cell Wall-DNA Complex)
  • VTX958
  • ABP 654 (Ustekinumab Biosimilar)
  • AVT04 (Ustekinumab Biosimilar)
  • Ad-TD-Nsil12
  • BAT2206 (Ustekinumab Biosimilar)
  • Corvax12
  • CT-P43 (Ustekinumab Biosimilar)
  • Expressgraft (Anti-Tumor IL-12)
  • INO-9112
  • JCXH-211
  • M032
  • SB17 (Ustekinumab Biosimilar)
  • VG201
  • ABOD2011
  • ADV/IL-12 Gene Therapy
  • AGX-148
  • AN2898
  • AS1409
  • ASP9801
  • BFI-751 (Ustekinumab Biosimilar)
  • Bmab1200 (Ustekinumab Biosimilar)
  • CAR-T Targeting Nectin4/FAP
  • DF6002
  • DMB-3115 (Ustekinumab Biosimilar)
  • Descartes-25
  • EGFR IL12 CART Cells
  • FYB202 (Ustekinumab Biosimilar)
  • GX-051
  • INO-5151
  • INXN-3001
  • JCAR020
  • MEDI1191
  • MEDI9253
  • MVR-C5252
  • Neulara (Ustekinumab Biosimilar)
  • ONCR-177
  • PF-07261271
  • RPTR-168
  • RT-111 (Ustekinumab Biosimilar)
  • RTX-224
  • RTX-321
  • SAR441000
  • Tbio-6517
  • TG6050
  • WTX-330
  • XTX301
  • Bactrl-IL-12
  • Detalimogene Voraplasmid (EG-70)
  • Dodekin (F8-IL12)

Clinical Activity and Developments of Interleukin-12 (IL-12) Analogues

As of July 2023, various companies have approximately 126 products for 232 diseases. For these diseases, many trials are being conducted by players globally. For instance,

  • D. Anderson Cancer Center is conducting a Phase 2 clinical trial to evaluate the efficacy of combination treatment with MEDI0457 (iINO-3112) and durvalumab (MEDI4736) in patients with Recurrent/Metastatic Human Papilloma Virus associated cancers that were expected to complete by December 2022.
  • The University of Alabama is conducting a Phase 1/2 clinical trial to study Pembrolizumab and M032 (NSC 733972), a genetically engineered HSV-1 expressing IL-12, in patients with Recurrent/Progressive and newly diagnosed Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma that is expected to complete by March 2025.
  • Sonnet BioTherapeutics is conducting a Phase1/2 clinical trial to assess the combination of SON-1010 (IL12-FHAB) and Atezolizumab in patients with Platinum-resistant Ovarian Cancer that is expected to complete by May 2025.

Molecule name

Number of studies

Stelara (ustekinumab)


rocakinogene sifuplasmid (INO-9012)




Ozespa (briakinumab)


Tavo (tavokinogene telsaplasmid)


Target Indication Analysis of Interleukin-12 (IL-12) Analogues

IL-12 is used in various indications due to its potent immunomodulatory properties. One of the primary areas of use is in cancer immunotherapy, where IL-12 is employed to bolster the body's immune response against tumors. It activates natural killer (NK) cells and T lymphocytes, enhancing their cytotoxic activity against cancer cells. Additionally, IL-12 finds application in managing chronic viral infections, such as hepatitis B and C, by promoting antiviral responses. Furthermore, IL-12's ability to regulate the immune system makes it a potential treatment for autoimmune disorders like multiple sclerosis, where it can help modulate the aberrant immune response. However, precise dosing and targeted delivery are critical to avoid potential adverse effects, as IL-12's potency can lead to immune-related toxicities. Despite these challenges, harnessing the therapeutic potential of IL-12 continues to hold promise for advancing immunotherapies and improving outcomes in various debilitating conditions.

Frequently Asked Questions

Stelara (ustekinumab) is the only FDA approved IL-12 Analogue drug.

These find use in the treatment in cancer immunotherapy like Cutaneous T-cell Lymphoma, Non-Hodgkin’s Lymphoma, Glioblastoma, Hepatitis B and C and many more

AbbVie, AstraZeneca, Takeda Pharmaceuticals, Pfizer and Mezzion Pharma are some of the major market players for IL-12 Analogues.

Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and rising incidence of various types of diseases like Cutaneous T-cell Lymphoma, Glioblastoma, Asthma, Mycobacterium infections and others are the key opportunities for IL-12 Analogues in the market.

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