The NF-?B inhibitors market is poised for growth driven by the increasing prevalence of cancer, autoimmune, and inflammatory diseases where NF-?B plays a central role. Additionally, the expected launch of emerging NF-?B inhibitors such as BioVie' bezisterim (NE3107), Entero Therapeutics' niclosamide (FW-UP), niclosamide (FW-ICI-AC), and others will further propel the NF-?B inhibitors market growth.
LAS VEGAS, Sept. 18, 2025 /PRNewswire/ -- DelveInsight's NF-?B Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report 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-?B 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).
Key Takeaways from the NF-?B Inhibitors Market Report
- As per DelveInsight's analysis, the total market size of NF-?B inhibitors in 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-?B inhibitor companies, such as Biovie, Entero Therapeutics, Accendatech, BioMimetix, and others, are developing novel NF-?B inhibitors that can be available in the NF-?B inhibitors market in the coming years.
- Some of the key NF-?B inhibitors in 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-?B inhibitors market share @ NF-?B Inhibitors Market Report
Key Factors Driving the NF-?B Inhibitors Market
Growing unmet disease burden
NF-?B 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-?B 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-?B inhibitors clinical activity
NF-?B 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-?B Inhibitors Market Analysis
Despite its central role in pathophysiology, there are currently no NF-?B inhibitors approved for clinical use, underscoring the unmet medical need and the complexity of targeting this pathway effectively and safely. Several emerging NF-?B 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-?B 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-?B modulation.
In the inflammatory disease space, niclosamide, a repurposed anthelmintic with NF-?B 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-?B inhibitors has historically been challenged by concerns over off-target effects and immunosuppression, given NF-?B'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-?B offers a clear benefit-risk advantage.
Learn more about the NF-?B inhibitors @ NF-?B Inhibitors Analysis
NF-?B Inhibitors Competitive Landscape
NF-?B 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-?B-driven inflammatory mediators, such as tumor necrosis factor alpha (TNF-a), while preserving their normal physiological roles.
Entero Therapeutics' FW-UP is 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-AC is 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-?B 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-?B inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about NF-?B inhibitors clinical trials, visit @ NF-?B Inhibitors Treatment
Recent Developments in the NF-?B 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-?B Inhibitors Overview
NF-?B is a family of inducible transcription factors that play a key role in controlling immune and inflammatory responses. Often simply called NF-?B, these proteins usually function as dimers, with the canonical p50/p65 (NF-?B1/RelA) heterodimer being the most extensively studied. As a widely expressed and highly versatile transcription factor, NF-?B 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-?B is particularly essential for coordinating immune responses to pathogens and maintaining immune system balance.
NF-?B Inhibitors Epidemiology Segmentation
The NF-?B 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-?B Inhibitors target patient pool is segmented into:
- Total Cases of Selected Indications for NF-?B Inhibitor
- Total Eligible Patient Pool of Selected Indications for NF-?B Inhibitor
- Total Treated Cases of Selected Indications for NF-?B Inhibitor
NF-?B Inhibitors Report Metrics | Details |
Study Period | 2020-2034 |
NF-?B Inhibitors Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report | Alzheimer Disease, Parkinson Disease, Long COVID, Ulcerative Proctitis, Ulcerative Proctosigmoiditis, Grades 1 and 2 Immune Checkpoint Inhibitor-Associated Colitis, and others |
Key NF-?B Inhibitors Companies | Biovie, Entero Therapeutics, Accendatech, BioMimetix, and others |
Key NF-?B Inhibitors | Bezisterim (NE3107), Niclosamide (FW-UP), Niclosamide (FW-ICI-AC), ACT001, BMX-001, and others |
Scope of the NF-?B Inhibitors Market Report
- NF-?B Inhibitors Therapeutic Assessment: NF-?B Inhibitors current marketed and emerging therapies
- NF-?B Inhibitors Market Dynamics: Conjoint Analysis of Emerging NF-?B Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, NF-?B Inhibitors Market Access and Reimbursement
Discover more about NF-?B inhibitors in development @ NF-?B Inhibitors Clinical Trials
Table of Contents
1 | NF-?B Inhibitors Market Key Insights |
2 | NF-?B Inhibitors Market Report Introduction |
3 | Executive Summary of NF- kappa (?) B Inhibitors |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology of NF-?B Inhibitor |
6 | NF-?B Inhibitor Market Overview at a Glance in the 7MM |
6.1 | NF-?B Inhibitors Market Share (%) Distribution by Therapies in 2024 |
6.2 | NF-?B Inhibitors Market Share (%) Distribution by Therapies in 2034 |
6.3 | NF-?B Inhibitors Market Share (%) Distribution by Indications in 2024 |
6.4 | NF-?B Inhibitors Market Share (%) Distribution by Indications in 2034 |
7 | NF-?B Inhibitor: Background and Overview |
7.1 | Introduction |
7.2 | Potential of NF-?B Inhibitor in Different Indications |
7.3 | Clinical Applications of NF-?B Inhibitor |
8 | NF-?B Inhibitors Target Patient Pool |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: 7MM |
8.3 | Epidemiology Scenario in the 7MM |
8.4 | Total Cases in Selected Indications for NF-?B Inhibitor in the 7MM |
8.5 | Total Eligible Patient Pool for NF-?B Inhibitor in Selected Indications in the 7MM |
8.6 | Total Treated Cases in Selected Indications for NF-?B Inhibitor in the 7MM |
9 | Emerging Therapies of NF-?B Inhibitor |
9.1 | Key Competitors |
9.2 | Bezisterim (NE3107): Biovie |
9.2.1 | Product Description |
9.2.2 | Other Developmental Activities |
9.2.3 | Clinical Development |
9.2.3.1 | Clinical Trial Information |
9.2.4 | Safety and Efficacy |
9.2.5 | Analyst Views |
9.3 | FW-UP (niclosamide): Entero Therapeutics |
List to be continued in the final report… | |
10 | NF-?B Inhibitor Market: Seven Major Market Analysis |
10.1 | Key Findings |
10.2 | Market Outlook of NF-?B Inhibitor |
10.3 | Conjoint Analysis of NF-?B Inhibitor |
10.4 | Key Market Forecast Assumptions of NF-?B Inhibitor |
10.5 | Total Market Size of NF-?B Inhibitor in the 7MM |
10.6 | Market Size of NF-?B Inhibitor by Indication in the7MM |
10.7 | The United States NF-?B Inhibitors Market Size |
10.7.1 | Total Market Size of NF-?B Inhibitors in the United States |
10.7.2 | Market Size of NF-?B Inhibitor by Indication in the United States |
10.7.3 | Market Size of NF-?B Inhibitor by Therapies in the United States |
10.8 | EU4 and the UK NF-?B Inhibitors Market Size |
10.9 | Japan NF-?B Inhibitors Market Size |
11 | Market Access and Reimbursement of NF-?B Inhibitors |
12 | SWOT Analysis of NF-?B Inhibitors |
13 | KOL Views of NF-?B Inhibitors |
14 | Unmet Needs of NF-?B Inhibitors |
15 | Bibliography |
16 | NF-?B Inhibitors Market Report Methodology |
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