Dapansutrile for acute gout flares
phase 2drug program · high · Fri Jan 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate oral dapansutrile for safety and efficacy in reducing pain and inflammation during acute gout flares driven by IL-1β.
Oral selective NLRP3 inflammasome inhibitor tested in gout flare clinical trials, including an open-label dose-adaptive phase 2a study and a later tablet study in subjects with acute gout flare.
ClinicalTrials.gov record for a dapansutrile tablet study in acute gout flare was published on 2023-01-06.
The 2020 phase 2a gout flare trial reported reductions in patient-reported target joint pain by day 3 and day 7 across dapansutrile dose groups, with a satisfactory safety profile; serious adverse events were considered unrelated to study drug.
Dapansutrile for moderate COVID-19 symptoms and early cytokine release syndrome
undiscloseddrug program · high · Thu Sep 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Assess whether oral dapansutrile can reduce or prevent NLRP3-mediated hyperinflammation and progression of cytokine release syndrome in moderate COVID-19.
Clinical study of orally administered dapansutrile in confirmed SARS-CoV-2 infection with moderate symptoms and evidence of early cytokine release syndrome.
ClinicalTrials.gov record for the COVID-19 dapansutrile study was published on 2020-09-24.
Dapansutrile for stable systolic heart failure
phase 1drug program · high · Wed May 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate safety and pharmacodynamic effects of dapansutrile in stable systolic heart failure patients with systemic inflammation.
Phase 1b randomized, double-blind, single-center, sequential cohort dose-escalation study of dapansutrile or placebo in subjects with LVEF ≤40%, NYHA II-III symptoms, and hsCRP >2 mg/L.
ClinicalTrials.gov record for the heart failure dapansutrile study was published on 2018-05-16.
Dapansutrile for Schnitzler's syndrome
phase 2drug program · high · Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Test dapansutrile as a proof-of-concept therapy for Schnitzler's syndrome in patients controlled by anakinra therapy.
Pilot open-label phase 2, single-center, repeat-dose, single-cohort safety, pharmacodynamics, and efficacy study of dapansutrile capsules in 5 to 10 subjects.
ClinicalTrials.gov record for the Schnitzler's syndrome pilot study was published on 2018-05-15.
Dapansutrile for Alzheimer's disease cognitive impairment
preclinicalresearch program · medium
Investigate whether NLRP3 inflammasome inhibition with OLT1177 can rescue cognitive impairment in an Alzheimer's disease mouse model.
Preclinical mouse-model study of OLT1177 targeting neuroinflammation associated with Alzheimer's disease.
A publication reported that OLT1177 rescues cognitive impairment in a mouse model of Alzheimer's disease.
Dapansutrile for experimental allergic asthma
preclinicalresearch program · medium
Evaluate whether NLRP3 inflammasome inhibition with OLT1177 ameliorates experimental allergic asthma.
Preclinical mouse study of the NLRP3 inflammasome inhibitor OLT1177 in experimental allergic asthma.
A 2022 Allergy publication reported that OLT1177 ameliorates experimental allergic asthma in mice.
Dapansutrile for spinal cord injury neuroinflammation
preclinicalresearch program · high
Reduce neuroinflammation, tissue damage, and functional impairment after acute spinal cord injury by inhibiting NLRP3-mediated IL-1β and IL-18 processing.
Intraperitoneal OLT1177 treatment after spinal cord contusion injury, with neurological, histological, cytokine, neutrophil, and macrophage assessments.
A 2022 Experimental Neurology publication reported functional protection and myelin preservation after spinal cord injury in preclinical testing.
OLT1177 reduced IL-1β levels, diminished later neutrophil and macrophage accumulation, protected against neurological deficits, and reduced histological evidence of damage at 200 mg/kg.
Dapansutrile for synucleinopathies
preclinicalresearch program · high
Evaluate dapansutrile as a disease-modifying NLRP3 inhibitor for Parkinson's disease and multiple system atrophy models involving α-synuclein pathology and microglial activation.
Chronic oral dapansutrile treatment in α-synuclein preformed fibril and PLP-α-syn mouse models, with behavioral, histopathological, pharmacokinetic, transcriptomic, and plasma biomarker readouts.
A 2026 Journal of Neuroinflammation publication reported preclinical efficacy and microglial transcriptomic modulation in PD and MSA models.
Treatment improved motor performance, reduced α-synuclein inclusions, attenuated gliosis, mitigated nigral neurodegeneration, and reversed disease-associated microglial transcriptional signatures; plasma IL-18 and NfL correlated with outcomes.
Dapansutrile translational biomarker program for synucleinopathies
exploratorybiomarker · medium
Assess plasma IL-18 and neurofilament light chain as translational biomarkers of target engagement and treatment efficacy for dapansutrile in α-synucleinopathy models.
Measurement of plasma IL-18 and NfL levels alongside neuropathological and functional outcomes in dapansutrile-treated PD and MSA mouse models.
The 2026 synucleinopathy publication reported biomarker correlations with neuropathological and functional outcomes.
Plasma IL-18 and NfL levels correlated with neuropathological and functional outcomes, supporting their potential as biomarkers of target engagement and efficacy.
Olatec oral NLRP3 antagonist platform
undisclosedplatform · high
Develop oral NLRP3 antagonist therapeutics for acute and chronic inflammatory diseases mediated by Interleukin-1.
Small-molecule inflammasome-inhibition platform centered on dapansutrile and a broader library of approximately 40 pharmaceutical candidates targeting NLRP3, IL-1β, and IL-18 biology.
Olatec states its platform includes approximately 40 pharmaceutical candidates and more than 180 patents and patent applications globally.
