CLE-600 Parkinson’s Disease

Developing a novel treatment for Parkinson’s disease patients, for better nights and better mornings


Clexio is developing CLE-600, a pill for the treatment of Parkinson’s disease nocturnal symptoms and Early Morning OFF.

CLE-600 is a new investigational drug that has not been approved for commercial distribution.

Unmet need in the treatment of Parkinson’s disease

Parkinson’s disease (PD) develops as dopamine-producing nerve cells in an area of the brain that controls movement gradually die. The reduced synthesis of dopamine causes the movement problems characteristic to Parkinson’s: stiffness, tremors, and difficulty with balance and coordination occurring during the day and night. PD is the second-most common neurodegenerative disease after Alzheimer’s disease, with US prevalence estimated at ~1M individuals.

One common struggle for Parkinson’s patients is troubled nights and morning akinesia (loss of ability to move your muscles voluntarily). Estimates show nocturnal symptoms and Early Morning Akinesia/OFF (EMO) to be prevalent in more than 60% of Parkinsonian patients, reducing patients’ quality of life and daytime function.

Current available dopaminergic treatments do not cover the duration and levels required for clinical efficacy along the entire night.

Our program

Scientific aspects

CLE-600 is designed to achieve stable and prolonged levels of Levodopa, used as first-line treatment to replace dopamine in Parkinson’s patients for decades. CLE-600 aims to control patient symptoms during the night and into the early morning. CLE-600 uses Clexio’s proprietary Oral Long Acting Release (OLAR®) drug delivery platform.

  • Solution dedicated to Parkinson’s-related nocturnal problems and morning akinesia
  • Targeting stable Levodopa concentrations at or above effective night therapeutic levels for 8–10 hours
  • Once-daily capsule to be taken in the evening

Clinical aspects

Two Phase 1 studies were completed. Studies found that the administration of CLE-600 was safe and well tolerated, and a prolonged Levodopa pharmacokinetic profile was achieved.

The company is now planning for the first study in patients with Parkinson’s disease.

* Patient voices throughout this website are paraphrased examples of typical experiences of people suffering from this disease.
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