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    DRUG CLASS:

    NLRP3 inhibitor

    Related drugs:
    6d
    RIVULET: A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events (clinicaltrials.gov)
    P2, N=162, Recruiting, Genentech, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events
    9d
    UNITE-ALS: Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis (clinicaltrials.gov)
    P2, N=206, Active, not recruiting, Zydus Therapeutics Inc.
    New P2 trial
    |
    NEFL (Neurofilament Light Chain)
    12d
    RRx-001 inhibits G6PD to deplete NADPH and trigger disulfidptosis coupled with DAMP-mediated immunogenic cell death in hepatocellular carcinoma. (PubMed, Cell Death Discov)
    In vivo, RRx-001 significantly inhibits tumor growth, enhances T-cell infiltration, promotes M1 macrophage polarization, downregulates PD-L1 expression, and strengthens anti-tumor immunity through T cell-related pathways. With both metabolic and immunomodulatory effects, RRx-001 provides a basis for novel HCC therapies, and future research could explore its synergistic effects with immune checkpoint inhibitors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • HMGB1 (High Mobility Group Box 1) • G6PD (Glucose-6-Phosphate Dehydrogenase)
    |
    PD-L1 expression
    |
    nibrozetone (RRx-001)
    20d
    UNITE-ALS: Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis (clinicaltrials.gov)
    P2, N=82, Active, not recruiting, Zydus Therapeutics Inc.
    New P2 trial
    |
    NEFL (Neurofilament Light Chain)
    23d
    USNO.24.002: Usnoflast Neuromuscular Investigation for Treatment Efficacy in ALS (UNITE-ALS) (2025-522580-15-00)
    P1/2, N=52, Not yet recruiting, Zydus Therapeutics Inc.
    New P1/2 trial
    27d
    A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants (clinicaltrials.gov)
    P1, N=78, Recruiting, AC Immune SA
    New P1 trial
    27d
    Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare (clinicaltrials.gov)
    P2/3, N=300, Recruiting, Olatec Therapeutics LLC | Trial completion date: Aug 2026 --> Jan 2027 | Trial primary completion date: Jul 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    dapansutrile (OLT1177)
    28d
    Targeting NLRP3 inflammasome: a novel strategy for improving immune checkpoint inhibitor-associated pneumonitis. (PubMed, Transl Lung Cancer Res)
    Therapeutic interventions with NLRP3 inflammasome inhibitors (MCC950 and dapansutrile) and a macrophage-depleting agent (clodronate liposomes) were evaluated by micro-computed tomography (CT), histopathology, and serum inflammatory cytokine assays. The findings revealed: (I) significant upregulation of NLRP3 inflammasome pathway-related genes and downstream factors (IL-1β, IL-18) in CIP mouse lungs, alongside increased macrophage infiltration; (II) pneumonitis injury was markedly alleviated and serum inflammatory cytokine levels were reduced by both NLRP3 inflammasome inhibition and macrophage depletion; (III) dapansutrile downregulated NLRP3 expression via inhibition of the NF-κB pathway; (IV) enriched macrophage subpopulations (Mac-IL1B) expressing high levels of NLRP3 were identified in CIP patients. This study provides the first evidence that NLRP3 inflammasome activation constitutes a key upstream mechanism in CIP pathogenesis, offering novel therapeutic strategies for targeted intervention.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    IL18 (Interleukin 18) • IL1B (Interleukin 1, beta) • NLRP3 (NLR Family Pyrin Domain Containing 3)
    |
    clodronate disodium • dapansutrile (OLT1177)
    1m
    SERENIA: A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. (clinicaltrials.gov)
    P2, N=124, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    1m
    RIVULET: A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, Genentech, Inc.
    New P2 trial • Adverse events
    1m
    VTX2735-202: Phase 2a Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis (2025-524784-20-00)
    P1/2, N=10, Not yet recruiting, Zomagen Biosciences Limited
    New P1/2 trial
    1m
    DAPA-PD: A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease (clinicaltrials.gov)
    P2, N=36, Recruiting, Cambridge University Hospitals NHS Foundation Trust | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Feb 2026
    Enrollment open • Trial initiation date
    |
    CRP (C-reactive protein)
    |
    dapansutrile (OLT1177)