Current Clinical Trials for OLT1177® Dapansutrile
​(click on study title to link to clinicaltrialsregister.eu​)

Study OLT1177-07 | OLT1177® Capsules for a Rare Disease
A Phase 2 pilot, open-label, single-center, repeat dose, proof-of-concept safety, pharmacodynamics and efficacy study of orally administered investigational drug (OLT1177®  Capsules) in subjects with a rare disease called Schnitzler’s Syndrome.

Completed Clinical Trials
​(click on study title to link to clinicaltrials.gov or clinicaltrialsregister.eu​)

Study OLT1177-01 | 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.

Study OLT1177-02 | 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.

Study OLT1177-03 | 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.

Study OLT1177-04 | 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.

​Study OLT1177-05 | 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.

Study OLT1177-06 | 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.