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CLE
CLE is a combination formulation of carbidopa and levodopa in an extended-release delivery system designed to provide more consistent dopamine replacement in the brain for Parkinson's disease management.
CLE is a combination formulation of carbidopa and levodopa in an extended-release delivery system designed to provide more consistent dopamine replacement in the brain for Parkinson's disease management. Used for Parkinson's disease.
At a glance
| Generic name | CLE |
|---|---|
| Also known as | carbidopa/levodopa/entacapone |
| Sponsor | Impax Laboratories, LLC |
| Drug class | Dopamine replacement therapy / Levodopa combination |
| Target | Dopamine pathway; decarboxylase inhibition |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Levodopa is converted to dopamine in the brain to replace depleted neurotransmitter levels in Parkinson's disease. Carbidopa is a decarboxylase inhibitor that prevents premature conversion of levodopa to dopamine in the periphery, allowing more levodopa to reach the brain. The extended-release formulation provides sustained drug delivery to reduce motor fluctuations.
Approved indications
- Parkinson's disease
Common side effects
- Dyskinesia
- Motor fluctuations
- Nausea
- Dizziness
- Orthostatic hypotension
Key clinical trials
- A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (PHASE2, PHASE3)
- A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) (PHASE2)
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) (PHASE3)
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (PHASE3)
- A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (PHASE2)
- CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis (NA)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus (PHASE2)
- Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CLE CI brief — competitive landscape report
- CLE updates RSS · CI watch RSS
- Impax Laboratories, LLC portfolio CI