Current Clinical Studies


Novus Therapeutics is dedicated to the highest standards in clinical research and keeping the patient and healthcare communities informed about our clinical studies.  For the latest updated information on our clinical studies, please refer to www.clinicaltrials.gov and eudract.ema.europa.eu (for clinical trials conducted in the European Union).

Study OP0201-C-002 (“C-002”)

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Study OP0201-C-002 (“C-002”) is a phase 1 clinical trial designed to evaluate safety and tolerability of daily intranasal administration of OP0201 over 14 consecutive days in 30 healthy adults. The randomized, double-blind, placebo-controlled, parallel-group, dose-escalation trial includes a 30 mg per day dose (Cohort A) and 60 mg per day dose (Cohort B) of OP0201. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03748758.

Study OP0201-C-006 (“C-006”)

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Study OP0201-C-006 (“C-006”) is an exploratory phase 2a clinical trial designed to evaluate safety, tolerability, and efficacy of daily intranasal administration of OP0201 over 10 consecutive days in up to approximately 140 pediatric patients, 6 to 24 months of age, with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group trial explores the effects of a 20 mg per day dose of OP0201 as an adjunct to oral antibiotics. Patients will receive 10 days of treatment and will be followed for up to 30 days, during which multiple endpoints will be explored. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03818815.