Research

The expertise and commitment of our R&D and management teams, alongside a fruitful collaborations with academic and independent research institutes and contract research organizations, contribute to Neurim Pharmaceuticals’ remarkable successes in drug discovery and development. Neurim Pharmaceuticals has one product registered, Circadin® – prolonged release melatonin for insomnia, and several molecules in the pipeline for the treatment of other CNS disorders.

Exploratory
Preclinical
Phase I
Phase II
Phase III
Marketing

PD* = Parkinson’s Disease // AD** = Alzheimer’s Disease

Paediatric Prolonged-Release Melatonin has successfully completed a Phase III clinical trial in neurodevelopmental disabled children suffering from sleep disorders. Neurim is advancing with regulatory submissions for this product.
The company’s lead drug candidate Piromelatine (Neu-P11) is a novel compound under development for sleep and cognition in Insomnia and Alzheimer’s Disease. It has completed a Phase II clinical trial for insomnia. A Phase II randomized, placebo controlled dose ranging study is underway, that is intended to evaluate efficacy and safety of Piromelatine for cognitive skills global functioning and sleep in patients with mild to moderate Alzheimer’s Disease is under way.

Two more of its compounds (for neuropathic pain Alzheimer’s, and Parkinson’s Disease) are expected to reach final preclinical stages in the near term.

Products

Circadin® 2mg: a proprietary prolonged-release melatonin formulation, approved for treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 years or over. Circadin® has been approved by several agencies globally including the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic) and the Israeli Ministry of Health (MOH). More than 5 Million patients in over 40 countries were treated with Circadin® since its launch.

Pediatric PRM: in a response to an unmet medical need, Neurim is now conducting a Phase III clinical study with Pediatric PRM for the treatment of sleep problems in children with Pervasive Developmental Disorders (PDD) and neurogenetic diseases.

Piromelatine: the company’s lead drug candidate Piromelatine (Neu-P11) has completed a Phase II clinical trial for insomnia and enters a Phase II randomized, placebo controlled dose ranging study intended to evaluate efficacy and safety for cognitive skills global functioning and sleep in patients with mild to moderate Alzheimer’s Disease.

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  • Circadin

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  • Recent news

    • Circadin® 2mg (prolonged-release melatonin) is now funded for insomnia in children and adolescents with Neurodevelopmental Disorders in New Zealand
    • Circadin® 2mg (prolonged-release melatonin) is now commercially available in Argentina
    • Neurim Pharmaceuticals Grants Exeltis Marketing Rights for Paediatric Prolonged-Release Melatonin (“PedPRM”) in Spain
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