Current Clinical Trials for OLT1177® Dapansutrile
(click on study title for further information on clinicaltrials.gov or clinicaltrialsregister.eu )
PODAGRA II | Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
A multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177® Capsules), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare.
A multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177® Capsules), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare.
DREAM | A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
A Phase 1/2 Investigator-initiated clinical study evaluating combination treatment of Olatec’ selective NLRP3 inhibitor, dapansutrile (OLT1177®), and checkpoint inhibitor pembrolizumab® (Keytruda) in patients with PD-1 refractory advanced melanoma.
A Phase 1/2 Investigator-initiated clinical study evaluating combination treatment of Olatec’ selective NLRP3 inhibitor, dapansutrile (OLT1177®), and checkpoint inhibitor pembrolizumab® (Keytruda) in patients with PD-1 refractory advanced melanoma.
Dapan-Dia |Dapansutrile in Diabetes and Diabetes-Related Complications
A Phase 2 Investigator-initiated clinical study in up to 300 patients with type 2 diabetes mellitus (T2D) and diabetes-related complications. The trial will be conducted in Switzerland and EU centers of excellence in diabetes.
A Phase 2 Investigator-initiated clinical study in up to 300 patients with type 2 diabetes mellitus (T2D) and diabetes-related complications. The trial will be conducted in Switzerland and EU centers of excellence in diabetes.
DAPA-PD | Anti-inflammatory Intervention with Dapansutrile (OLT1177®) for Parkinson’s Disease Modification
A Phase 2 Investigator-initiated clinical study involving approximately 36 subjects with early Parkinson’s disease. This trial, taking place at the University of Cambridge in the UK, will be funded by Cure Parkinson's. Patients will be treated for up to 12 months allowing for the potential to measure a disease modifying effect on motor function and non-motor symptoms
A Phase 2 Investigator-initiated clinical study involving approximately 36 subjects with early Parkinson’s disease. This trial, taking place at the University of Cambridge in the UK, will be funded by Cure Parkinson's. Patients will be treated for up to 12 months allowing for the potential to measure a disease modifying effect on motor function and non-motor symptoms
Completed Clinical Trials
(click on study title to link to clinicaltrials.gov or clinicaltrialsregister.eu)
OLT1177® Capsules for Cardiovascular Disease
A Phase 1b, randomized, double-blinded, dose escalation, single center, repeat-dose safety and pharmacodynamics study of orally administered investigational drug (OLT1177® Capsules) in subjects with NYHA II-III Systolic Heart Failure.
PODAGRA | OLT1177® Capsules for an Acute Gout Flare
A Phase 2a, single-center, sequential, adaptive dose progression proof-of-concept safety and efficacy study of orally administered investigational drug (OLT1177® Capsules) in subjects with an acute gout flare.
OLT1177® Capsules Safety Study
A Phase 1 randomized, placebo-controlled, sequential ascending-dose safety and pharmacokinetic study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177® Capsules or Placebo Capsules). A total of 35 subjects were enrolled across 6 cohorts randomized in a ratio of 5 active to 1 placebo.
OLT1177® Gel for Knee OA
A Phase 2b randomized, placebo-controlled safety and efficacy study of subjects with moderate-to-severe osteoarthritis of the knee following treatment with investigational drug (OLT1177® Gel or Placebo Gel) for six weeks. A total of 202 subjects were enrolled and randomized in a ratio of 1 active to 1 placebo.
OLT1177® Gel for Knee OA
A Phase 2a randomized, placebo-controlled safety and efficacy study of subjects with moderate-to-severe osteoarthritis of the knee following treatment with investigational drug (OLT1177® Gel or Placebo Gel) for two weeks. A total of 79 subjects were enrolled and randomized in a ratio of 2 active to 1 placebo.
OLT1177® Gel Safety Study
A Phase 1 randomized, placebo-controlled, sequential ascending-dose safety and pharmacokinetic study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177® Gel or Placebo Gel). A total of 36 subjects were enrolled across 6 cohorts randomized in a ratio of 5 active to 1 placebo.
A Phase 1b, randomized, double-blinded, dose escalation, single center, repeat-dose safety and pharmacodynamics study of orally administered investigational drug (OLT1177® Capsules) in subjects with NYHA II-III Systolic Heart Failure.
PODAGRA | OLT1177® Capsules for an Acute Gout Flare
A Phase 2a, single-center, sequential, adaptive dose progression proof-of-concept safety and efficacy study of orally administered investigational drug (OLT1177® Capsules) in subjects with an acute gout flare.
OLT1177® Capsules Safety Study
A Phase 1 randomized, placebo-controlled, sequential ascending-dose safety and pharmacokinetic study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177® Capsules or Placebo Capsules). A total of 35 subjects were enrolled across 6 cohorts randomized in a ratio of 5 active to 1 placebo.
OLT1177® Gel for Knee OA
A Phase 2b randomized, placebo-controlled safety and efficacy study of subjects with moderate-to-severe osteoarthritis of the knee following treatment with investigational drug (OLT1177® Gel or Placebo Gel) for six weeks. A total of 202 subjects were enrolled and randomized in a ratio of 1 active to 1 placebo.
OLT1177® Gel for Knee OA
A Phase 2a randomized, placebo-controlled safety and efficacy study of subjects with moderate-to-severe osteoarthritis of the knee following treatment with investigational drug (OLT1177® Gel or Placebo Gel) for two weeks. A total of 79 subjects were enrolled and randomized in a ratio of 2 active to 1 placebo.
OLT1177® Gel Safety Study
A Phase 1 randomized, placebo-controlled, sequential ascending-dose safety and pharmacokinetic study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177® Gel or Placebo Gel). A total of 36 subjects were enrolled across 6 cohorts randomized in a ratio of 5 active to 1 placebo.