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NLRP3 Protein Inhibitors Clinical Trials

(Albany, USA) DelveInsight’s NLRP3 Protein Inhibitors Pipeline Insight 2025 report highlights a dynamic and expanding pipeline, with over 20+ active companies developing more than 25+ NLRP3 protein inhibitors. The report provides an in-depth global overview of these pipeline assets across various stages of clinical development, underscoring the significant efforts by major pharmaceutical players to advance this therapeutic space.

NLRP3 inhibitors show promise not only in autoimmune and inflammatory diseases but also in neurodegenerative conditions such as Alzheimer’s, Parkinson’s, and multiple sclerosis, as well as metabolic disorders including gout and non-alcoholic steatohepatitis (NASH). This broad therapeutic potential is fueling growing market interest and investment.

The report offers comprehensive profiles of pipeline drugs, comparative analyses of clinical and preclinical-stage inhibitors, and insights into inactive or dormant assets. It further examines the factors driving and restraining development, highlighting key opportunities and potential risks within the clinical trial landscape. Overall, the study serves as a valuable resource for stakeholders seeking to understand the competitive dynamics, emerging trends, and growth potential within the NLRP3 protein inhibitors market.

This report emphasizes both the scientific promise and strategic significance of NLRP3 inhibitors, making it essential for companies, researchers, and investors aiming to navigate this evolving therapeutic domain.

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Key Takeaways from the NLRP3 Protein Inhibitors Pipeline Report

• DelveInsight’s NLRP3 protein inhibitors pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline NLRP3 protein inhibitors.
• Key NLRP3 protein inhibitors companies such as Halia Therapeutics, Ventus Therapeutics, EpicentRx, Zydus Lifesciences Limited, Monte Rosa Therapeutics, Inflammasome Therapeutics, Ventyx Biosciences, Biolexis Therapeutics, Halia Therapeutics, Olatec Therapeutics, Secarna Pharmaceuticals, Novo Nordisk, NodThera, and others are evaluating new NLRP3 protein inhibitors drugs to improve the treatment landscape.
• Promising pipeline NLRP3 protein inhibitors such as HT6184, VENT 02, Nibrozetone, ZYIL1, MRT-8102, Kamuvudine-9, VTX 3232, NLRP3 inflammasome inhibitor, Dapansutrile, NNC6022-0001, NLRP3 Research Program, NT 0796, and others are under different phases of NLRP3 protein inhibitors clinical trials.
• In September 2025, Shanghai Stock Exchange listed company HitGen Inc. (“HitGen”, SSE: 688222.SH), congratulates its partner BioAge Labs, Inc. (“BioAge”, NASDAQ: BIOA), a clinical-stage biotechnology company based in Emeryville, CA, USA, on the initiation of a Phase 1 clinical study of BGE-102, a novel, potent NLRP3 inhibitor developed from a hit compound identified using HitGen’s industry-leading DEL technology platform. The event triggers an undisclosed milestone payment to HitGen under the collaboration agreement between the two companies.
• In June 2025, Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory diseases driven by the NLRP3 inflammasome and IL-1β. The Company plans to initiate a Phase 1 study of MRT-8102 in the coming weeks and anticipates sharing initial results in H1 2026.
• In May 2025, Zydus, a leading, discovery-based, global pharmaceutical company today announced that the USFDA has granted ‘Fast Track Designation’ to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS). A drug that receives Fast Track Designation from the USFDA is eligible for accelerated approval and priority review, if the relevant criteria are met. The purpose of Fast Track Designation is to get important new drugs to the patients faster.
• In August 2024, Halia Therapeutics and Biolexis Therapeutics announced an ongoing collaboration that successfully identified a novel brain-penetrant small molecule candidate targeting NLRP3-driven neuroinflammation by leveraging Biolexis’ MolecuLern™ AI-enabled approach. This milestone represents a significant advancement in developing treatments for neuroinflammatory disorders, including Parkinson’s disease and other neurodegenerative conditions.
• In June 2024, NodThera announced positive data from its Phase Ib/IIa cardiovascular risk study in inflamed obese subjects, evaluating the effects of its oral, brain-penetrant NLRP3 inflammasome inhibitor NT-0796, on inflammatory, cardiovascular and metabolic risk parameters.
• In May 2024, Novo Nordisk successfully dosed the first participant in a Phase I clinical study for NNC6022-0001 (formerly known as VENT-01) – an oral NLRP3 inhibitor licensed by Novo Nordisk in September 2022.
• In April 2024, Ventus Therapeutics announced results from its Phase I clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor. The Phase I trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers.
• In March 2024, Parkinson’s UK announced the investment of GBP 2.1 million to support Neumora Therapeutics to carry out preclinical testing of NMRA-NLRP3, a NLRP3 inhibitor with the potential to reduce inflammation and protect brain cells in Parkinson’s.

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NLRP3 Protein Inhibitors Overview

NOD-like receptor family pyrin domain-containing 3 (NLRP3) protein is a key component of the innate immune system, playing a crucial role in the activation of the inflammasome. The NLRP3 inflammasome is responsible for the maturation and release of pro-inflammatory cytokines such as IL-1β and IL-18. This process is essential for host defense against pathogens but can lead to chronic inflammation when dysregulated. Overactivation of the NLRP3 inflammasome is implicated in a wide range of diseases, including autoimmune disorders, metabolic syndromes, neurodegenerative diseases, and certain cancers. Thus, targeting NLRP3 with specific inhibitors has become a promising strategy for treating these inflammatory conditions.

NLRP3 protein inhibitors work by either directly blocking the NLRP3 protein or interfering with its activation pathway, thereby preventing the assembly of the inflammasome and subsequent cytokine release. These inhibitors offer a novel therapeutic approach by addressing the root cause of inflammation rather than merely managing its symptoms. Several NLRP3 inhibitors are currently under development, with some already in clinical trials for diseases like gout, rheumatoid arthritis, and type 2 diabetes. Their ability to modulate the inflammatory response makes them a potential game-changer in the treatment of chronic inflammatory diseases, offering hope for more effective and targeted therapies.

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NLRP3 Protein Inhibitors Competitive Landscape

A snapshot of the Pipeline NLRP3 Protein Inhibitors Drugs mentioned in the report:

• Nibrozetone: EpicentRx
• ZYIL 1: Zydus Cadila
• HT6184: Halia Therapeutics
• VTX 3232: Ventyx Biosciences
• VENT 02: Ventus Therapeutics
• NNC6022-0001: Novo Nordisk
• Kamuvudine-9: Inflammasome Therapeutics
• MRT-8102: Monte Rosa Therapeutics

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NLRP3 protein inhibitors Emerging Drugs

Diacerein (Castle Creek Pharmaceuticals):

A slow-acting anthraquinone with anti-inflammatory properties, Diacerein and its metabolite rhein inhibit IL-1β and other pro-inflammatory cytokines. CCP-020, a 1% topical formulation, is hydrolyzed in the skin to rhein, blocking inflammatory pathways linked to Epidermolysis bullosa (EBS), strengthening epidermal tissue, and aiding blister healing. Currently in Phase III for EBS.

HT-6184 (Halia Therapeutics):

Targets NEK7 via an allosteric mechanism, disrupting NLRP3 inflammasome assembly and reducing inflammation. Preclinical studies show it also disassembles activated inflammasomes. In Phase II development for inflammatory pain.

VENT-02 (Ventus Therapeutics):

A potent, brain-penetrant NLRP3 inhibitor. Phase I trials showed it was safe, well-tolerated, and achieved full IL-1β inhibition, high CSF drug levels, and significant biomarker reduction. Supports once-daily dosing and is the company’s most advanced program.

NLRP3 Protein Inhibitors Therapeutics Assessment

The NLRP3 protein inhibitors pipeline report proffers an integral view of the emerging NLRP3 protein inhibitors segmented by stage, product type, molecule type, and route of administration. DelveInsight’s report covers around 25+ products under different phases of clinical development like

• Late-stage products (Phase III and
• Mid-stage products (Phase II and
• Early-stage products (Phase I/II and Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

NLRP3 Protein Inhibitors Route of Administration

• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Oral
• Parenteral
• Subcutaneous
• Topical

NLRP3 Protein Inhibitors Molecule Type

Products have been categorized under various Molecule types such as

• Vaccines
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule

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Scope of the NLRP3 Protein Inhibitors Pipeline Report

• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Therapeutics Assessment By Route of Administration: Infusion, Intradermal, Intramuscular, Intranasal, Intravaginal, Oral, Parenteral, Subcutaneous, Topical
• Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule
• Key NLRP3 Protein Inhibitors Companies: Monte Rosa Therapeutics (NASDAQ: GLUE), Ventyx Biosciences (NASDAQ: VTYX), Zydus Lifesciences Limited (BSE: 532321, NSE: ZYDUSLIFE), and Novo Nordisk (NYSE: NVO, OMX: NOVO-B), Halia Therapeutics, Ventus Therapeutics, EpicentRx, Inflammasome Therapeutics, Biolexis Therapeutics, Olatec Therapeutics, Secarna Pharmaceuticals, and NodThera, and others
• Key NLRP3 Protein Inhibitors Pipeline Therapies: HT6184, VENT 02, Nibrozetone, ZYIL1, MRT-8102, Kamuvudine-9, VTX 3232, NLRP3 inflammasome inhibitor, Dapansutrile, NNC6022-0001, NLRP3 Research Program, NT 0796, and others

Table of Contents

1. NLRP3 Protein Inhibitors Pipeline Report Introduction

2. NLRP3 Protein Inhibitors Pipeline Report Executive Summary

3. NLRP3 Protein Inhibitors Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. NLRP3 Protein Inhibitors Clinical Trial Therapeutics

6. NLRP3 Protein Inhibitors Pipeline: Late-Stage Products (Pre-registration)

7. NLRP3 Protein Inhibitors Pipeline: Late-Stage Products (Phase III)

8. NLRP3 Protein Inhibitors Pipeline: Mid-Stage Products (Phase II)

9. NLRP3 Protein Inhibitors Pipeline: Early-Stage Products (Phase I)

10. NLRP3 Protein Inhibitors Pipeline Therapeutics Assessment

11. Inactive Products in the NLRP3 Protein Inhibitors Pipeline

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Key Companies

14. Key Products in the NLRP3 Protein Inhibitors Pipeline

15. Unmet Needs

16. Market Drivers and Barriers

17. Future Perspectives and Conclusion

18. Analyst Views

19. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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