Nuclear Factor Kappa-Light-Chain-Enhancer of Activated B Cells (NF-κb) Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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NF-kb (Nuclear factor kappa light chain enhancer of activated B cells) is a family of transcription factors. These are highly conserved factors that control the transcription of DNA, cytokine production, apoptosis, cell growth, and cell survival. It plays a crucial role in regulating responses to infection. It has a role in cellular responses to stimuli such as stress, UV radiation, heavy metals, oxidized LDL, and bacterial and viral antigens. Proper regulation of NF-κB is crucial for the normal functioning of the organs and functions in the body. Incorrect regulation has been linked to various diseases like cancer, inflammatory and autoimmune diseases, septic shock, viral diseases, and improper immune development. Therefore, inhibiting it might be an approach to treating various conditions associated with the pathway. Research is being conducted globally to discover new and novel molecules for anti-IL-23 agents. The development and launch of new products will thus increase the revenue of the market in the forecasted years. According to the Department of Health and Human Services, in 2022, the USA had approximately 9.9 per 100,000 people suffering from Amyotrophic Lateral Sclerosis (AML). According to a research study, the incidence of AML in Europe is about 2.2 per 100,000 people in 2022. Therefore, there is an opportunity for the market players globally.

A number of these inhibitors are in the market, while many are in ongoing clinical trials. 66 companies have various products in their pipelines, with 51 products in various stages of clinical trials. 7 products are in Phase 4, 12 in Phase 3, 24 in Phase 2, and 8 in Phase 1 of the clinical trials.

Key Developments of NF-κB Inhibitors

  • In April 2020, FDA approved Bafiertam (monomethyl fumarate) for the treatment of adults with relapsing forms of Multiple Sclerosis (MS).

Approved Molecules Of Nf-Κb Inhibitors

  • Kremezin (Ast-120)
  • Fumaderm (Dimethyl Fumarate)
  • Careram (Iguratimod)
  • Erdotin (Erdosteine)
  • Kanglaite Injection (Klti)
  • Skilarence (Dimethyl Fumarate)
  • Bafiertam (Monomethyl Fumarate)

Drugs In The Pipeline Of Nf-Κb Inhibitors

  • Bardoxolone Methyl (Rta 402)
  • Vamorolone (Vbp15)
  • Hocena (Antroquinonol)
  • Imr-261
  • Saccovid (Efprezimod Alfa)
  • Triolex (Ne3107)
  • Edasalonexent (Cat-1004)
  • Kappaproct (Cobitolimod)
  • Dimethylamino Micheliolide (Act001)
  • Ornithine Phenylacetate Oral (Mnk-6106)
  • Hmpl-004
  • Dexanabinol (Ets2101)
  • Recoflavone (Da-6034)
  • Cbl137 Iv
  • Sar 113945
  • Tarenflurbil (Mk-50)
  • Ot-551
  • Trunoc (Tarenflurbil)
  • Dendrimer N-Acetyl-Cysteine (Op-101)
  • Dimethyl Fumarate-Controlled Release (Fp 187)
  • Niclosamide (Fw-1022)
  • Zenuzolac (Vgx-1027)
  • Apx3330
  • Kominox (Sodium Metaarsenite)
  • Lipocurc (Liposomal Curcumin)
  • Sdp-4
  • Curcumin/ Doxorubicin (Imx-110)
  • Luxeptinib (Cg-806)
  • Oleandrin (Pbi-05204)
  • Ornithine Phenylacetate Iv (Mnk-6105)
  • Quinacrine (Cbl0102)
  • Amg0103
  • Cbl0137 Ia
  • Cxa-10 Iv
  • Curcusome-Ra
  • Kanglaite Gelcap (Kltc)
  • Nf-Kappa-B Decoy Oligonucleotide Topical (Amg0101 Topical)
  • Rhn001
  • Sr13668
  • Apocynin/Paeonol (Akl-4)
  • Hypochlorous Acid (Pr022)
  • Meclocycline (Snx-1012)
  • Misetionamide (Gp-2250)
  • Resveratrol (Db02709)

Clinical Activity and Developments of NF-κB Inhibitors

As of June 2023, 66 companies have approximately 51 products for 243 diseases. For these diseases, 52 trials are being conducted by players globally. For instance,

  • Sunnybrook Health Sciences Centre is conducting a Phase 2 clinical trial to evaluate the safety of Withania Somnifera- NF-?b Inhibitor in patients with Amyotrophic Lateral Sclerosis that was expected t complete by September 2022.
  • Guang’anmen Hospital of China Academy of Chinese Medical Sciences is conducting a Phase 4 clinical trial to evaluate the efficacy and safety of Kanglaite injection (KLTi) for advanced non-small cell lung cancer (NSCLC) that is expected to complete by May 2022.
  • Kyowa Kirin Co., Ltd is conducting a Phase 3 clinical trial to study the efficacy of Bardoxolone Methyl in patients with Diabetic Kidney Disease.

Molecule name

Number of studies

Kremezin (AST-120)


Fumaderm (dimethyl fumarate)


Careram (iguratimod)


Erdotin (erdosteine)


Kanglaite Injection (KLTi)


Target Indication Analysis of NF-kb Inhibitors

Drugs like Kremezin (AST-120), Fumaderm (dimethyl fumarate), Careram (iguratimod) etc have been approved by the FDA and other regulatory agencies for the treatment of various indications. Kremezin (AST-120) has been approved for treating Kidney diseases, Chronic Kidney Failure, Chronic Renal Insufficiency, Inflammation, Urologic diseases and others. It is in the clinical trials for various other indications like Digestive system diseases, Acute kidney injury, Crohn’s disease, Fistula, and others. Fumaderm (dimethyl fumarate) is in the clinical trials for various indications like Psoriasis, Papulosquamous skin diseases, Autoimmune and Connective Tissue Diseases, and others. These have shown promising results in clinical trials and have sought approval for various indications by regulatory agencies globally.

Frequently Asked Questions

Kremezin (AST-120), Fumaderm (dimethyl fumarate), Careram (iguratimod), Erdotin (erdosteine), and Kanglaite Injection (KLTi) are approved by various regulatory agencies.

These are used in treating Chronic Kidney Failure, Chronic Renal Insufficiency, Psoriasis, Papulosquamous skin diseases, Autoimmune and Connective Tissue Diseases, and others.

Reata, Mitsubishi Tanabe, Golden Biotechnology, and Eisai are some of the major market players for NF-?B Inhibitors.

Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and changing lifestyles leading to various kinds of cancers are the key opportunities for NF-?B Inhibitors.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • Kyowa Kirin
  • Reata
  • Mitsubishi Tanabe
  • Biogen
  • Santhera
  • Golden Biotechnology
  • Eisai
  • R-Pharm
  • Recipharm
  • Alitair Pharma
  • Daewoong Pharma
  • Imara, Inc
  • Merck (Msd)
  • Biovie
  • Zhejiang Kanglaite Pharma
  • Almirall
  • Astria Therap
  • Index Pharma, Viatris
  • Tianjin Suntech Pharma
  • Mallinckrodt
  • Thermo Fisher Scientific
  • Hutchmed
  • E-Therap, Ceska Lekarnicka
  • Gl Pharmtech
  • Incuron
  • Sanofi
  • Nogra Pharma
  • Colby
  • Orizon Therapeutics
  • Ashvattha Therap
  • Forward Pharma
  • First Wave Bio
  • Geneone
  • Apexian
  • Ocuphire Pharma
  • Komipharm
  • Signpath Pharma
  • Silktech
  • Immix Biopharma
  • Aptose Biosci
  • Phoenix Biotech
  • Mallinckrodt
  • Incuron
  • Anges Mg
  • Incuron
  • Statera Biopharma
  • Complexa
  • Uniquest
  • J&J
  • Zhejiang Kanglaite Pharma
  • Anges Mg
  • Shionogi
  • Rh Nanopharma
  • Sri International
  • Akl Research And Development
  • Essa Pharma
  • Coserics
  • Panavance Therapy
  • Alzheimer's Disease Cooperative Study

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