The NF-kB inhibitors market is poised for growth driven by the increasing prevalence of cancer, autoimmune, and inflammatory diseases where NF-kB plays a central role. Additionally, the expected launch of emerging NF-kB inhibitors such as BioVie' bezisterim (NE3107), Entero Therapeutics' niclosamide (FW-UP), niclosamide (FW-ICI-AC), and others will further propel the NF-kB inhibitors market growth.
DelveInsight's NF-kB Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecastreport includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Alzheimer's Disease, Parkinson's Disease, Long COVID, Ulcerative Proctitis, Ulcerative Proctosigmoiditis, Grades 1 and 2 Immune Checkpoint Inhibitor-Associated Colitis, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging NF-kB inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
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Key Takeaways from the NF-kB Inhibitors Market Report
— As per DelveInsight's analysis, the total market size of NF-kB inhibitorsin the leading markets is expected to surge significantly by 2034.
— The report provides the total potential number of patients in the indications, such as Alzheimer's Disease, Parkinson's Disease, Long COVID, Ulcerative Proctitis, Ulcerative Proctosigmoiditis, Grades 1 and 2 Immune Checkpoint Inhibitor-Associated Colitis, and others.
— Leading NF-kB inhibitorcompanies, such as Biovie, Entero Therapeutics, Accendatech, BioMimetix, and others, are developing novel NF-kB inhibitorsthat can be available in the NF-kB inhibitorsmarket in the coming years.
— Some of the key NF-kB inhibitorsin clinical trials include Bezisterim (NE3107), Niclosamide (FW-UP), Niclosamide (FW-ICI-AC), ACT001, BMX-001, and others.
Discover which indication is expected to grab the major NF-kB inhibitors market share @ NF-kB Inhibitors Market Report
Key Factors Driving the NF-kB Inhibitors Market
Growing unmet disease burden
NF-kB sits at the crossroads of inflammation and tumor biology, so the pathway's involvement across autoimmune, neuroinflammatory and many cancers creates broad clinical demand for effective inhibitors.
Strong interest in neurodegenerative and neurological applications
Because NF-kB signaling is implicated in Alzheimer's, Parkinson's, long-COVID neurological symptoms and other CNS disorders, pipeline activity aimed at neurodegeneration (and the need for blood-brain-barrier-permeable molecules) is expanding market opportunity. BioVie's bezisterim (NE3107) programs illustrate that trend.
Expanding NF-kB inhibitors clinical activity
NF-kB inhibitors has a pipeline consisting of promising products such as BioVie' bezisterim (NE3107), Entero Therapeutics' niclosamide (FW-UP), niclosamide (FW-ICI-AC), Accendatech's ACT001, BioMimetix's BMX-001, and others.
NF-kB Inhibitors Market Analysis
Despite its central role in pathophysiology, there are currently no NF-kB inhibitors approved for clinical use, underscoring the unmet medical need and the complexity of targeting this pathway effectively and safely. Several emerging NF-kB inhibitors are now progressing through clinical trials, reflecting renewed interest and innovation in this space. Bezisterim (NE3107), developed by BioVie, is the most advanced candidate, currently in a Phase III trial for Alzheimer's disease, and in Phase II studies for Parkinson's disease and long COVID. If successful, it could become the first-in-class NF-kB inhibitor in neurology.
In oncology, ACT001 from Accendatech is in Phase II trials for recurrent glioblastoma, and is also being explored for diffuse intrinsic pontine gliomas (DIPG). Similarly, BMX-001 from BioMimetix is advancing through trials in rectal, ovarian, and endometrial cancers, with a focus on enhancing the effect of chemoradiation by reducing oxidative stress and inflammation through NF-kB modulation.
In the inflammatory disease space, niclosamide, a repurposed anthelmintic with NF-kB inhibitory properties, is being developed by Entero Therapeutics. FW-UP is in Phase II for ulcerative proctitis and proctosigmoiditis, while FW-ICI-AC is targeting immune checkpoint inhibitor (ICI)-associated colitis, a rising complication in immuno-oncology.
However, despite encouraging preclinical and early clinical data, the development of NF-kB inhibitors has historically been challenged by concerns over off-target effects and immunosuppression, given NF-kB's ubiquitous role in immune homeostasis. Future success will depend on the ability to achieve pathway specificity, optimize dosing, and identify disease contexts where modulation of NF-kB offers a clear benefit-risk advantage.
Learn more about the NF-kB inhibitors@ NF-kB Inhibitors Analysis
NF-kB Inhibitors Competitive Landscape
NF-kB inhibitors have a pipeline consisting of promising products such as BioVie's bezisterim (NE3107), Entero Therapeutics' niclosamide (FW-UP), niclosamide (FW-ICI-AC), and others, which are in late- and mid-stage clinical development.
Biovie is investigating bezisterim across Alzheimer's disease, Parkinson's disease, and Long COVID. Within these clinical programs, the company is also assessing whether the therapy can influence longevity, specifically by evaluating its capacity to lower DNA methylation levels in trial participants.
Bezisterim is an oral, blood-brain barrier-permeable small molecule that acts as an anti-inflammatory insulin sensitizer targeting extracellular signal-regulated kinase (ERK). Research indicates that it selectively blocks ERK- and NF-kB-driven inflammatory mediators, such as tumor necrosis factor alpha (TNF-a), while preserving their normal physiological roles.
Entero Therapeutics' FW-UPis an oral, niclosamide-based small molecule anti-inflammatory therapy being developed for the treatment of ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). It is currently under evaluation in a Phase IIb clinical trial to assess the safety and potential effectiveness of niclosamide in patients with these conditions. FW-UP may offer a safe treatment option for UP and UPS, which are localized forms of ulcerative colitis, a chronic inflammatory bowel disease (IBD) characterized by superficial ulcerations in the inner mucosal lining of the large intestine that do not extend into the muscle wall.
FW-ICI-ACis another oral niclosamide-based small molecule anti-inflammatory therapy from Entero Therapeutics, designed for the treatment of immune checkpoint inhibitor (ICI)-induced colitis and diarrhea in patients with metastatic cancer. The PASSPORT trial, a Phase IIa study evaluating the safety and potential efficacy of niclosamide for ICI-AC, received FDA IND clearance in Q4 2021.
The anticipated launch of these emerging therapies are poised to transform the NF-kB inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the NF-kB inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about NF-kB inhibitors clinical trials, visit @ NF-kB Inhibitors Treatment
Recent Developments in the NF-kB Inhibitors Market
— In May 2025, BioVie announced first patient enrollment in the Phase II ADDRESS-LC clinical trial (NCT06847191) evaluating bezisterim for the treatment of neurological symptoms associated with long COVID. The Company anticipates topline data to be available in the first half of 2026.
— In April 2025, BioVie announced that patient enrollment is now open for the Phase II SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim on motor and non-motor symptoms in patients with Parkinson's disease (PD) who haven't been treated with carbidopa/levodopa. The first patient in the trial has been enrolled, and the Company anticipates topline data to be available in late 2025 or early 2026.
— In February 2025, Accendatech, in collaboration with Nationwide Children's Hospital, plans a Phase II trial for Glioma in the USA in July 2025 (NCT06838676).
NF-kB Inhibitors Overview
NF-kB is a family of inducible transcription factors that play a key role in controlling immune and inflammatory responses. Often simply called NF-kB, these proteins usually function as dimers, with the canonical p50/p65 (NF-kB1/RelA) heterodimer being the most extensively studied. As a widely expressed and highly versatile transcription factor, NF-kB integrates signals from diverse stimuli, such as cytokines, pathogens, stress, and cellular damage. It acts as a crucial downstream effector in complex intracellular signaling pathways, regulating genes involved in inflammation, innate and adaptive immunity, cell proliferation, differentiation, survival, and apoptosis. NF-kB is particularly essential for coordinating immune responses to pathogens and maintaining immune system balance.
NF-kB Inhibitors Epidemiology Segmentation
The NF-kB Inhibitors market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2020-2034 across the leading markets. The total diagnosed prevalent cases of Parkinson's disease in the 7MM were 2.7 million in 2024. On the other hand, the total diagnosed prevalent cases of Alzheimer's disease in the 7MM were ~16 million in the same year.
The NF-kB Inhibitors target patient pool is segmented into:
— Total Cases of Selected Indications for NF-kB Inhibitor
— Total Eligible Patient Pool of Selected Indications for NF-kB Inhibitor
— Total Treated Cases of Selected Indications for NF-kB Inhibitor
Scope of the NF-kB InhibitorsMarket Report
— NF-kB Inhibitors Therapeutic Assessment: NF-kB Inhibitors current marketed and emerging therapies
— NF-kB InhibitorsMarket Dynamics: Conjoint Analysis of Emerging NF-kB Inhibitors Drugs
— Competitive Intelligence Analysis:SWOT analysis and Market entry strategies
— Unmet Needs, KOL's views, Analyst's views, NF-kB Inhibitors Market Access and Reimbursement
Discover more about NF-kB inhibitors in development @ NF-kB Inhibitors Clinical Trials
Table of Contents
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