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controlled-release levodopa / carbidopa
controlled-release levodopa / carbidopa is a Dopamine precursor with peripheral decarboxylase inhibitor Small molecule drug developed by Pfizer. It is currently FDA-approved for Parkinson's disease, Parkinsonism secondary to carbon monoxide poisoning or manganese intoxication.
Levodopa is converted to dopamine in the brain to replace deficient neurotransmitter levels, while carbidopa inhibits its premature breakdown in the periphery, allowing more levodopa to reach the brain.
Controlled-release levodopa/carbidopa is used to treat Parkinson's Disease, a condition studied in clinical trials. It is a small molecule modality that works by combining levodopa with carbidopa, a substance that helps increase the availability of levodopa in the brain.
At a glance
| Generic name | controlled-release levodopa / carbidopa |
|---|---|
| Sponsor | Pfizer |
| Drug class | Dopamine precursor with peripheral decarboxylase inhibitor |
| Target | Aromatic amino acid decarboxylase (AADC); dopamine pathway |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
In Parkinson's disease, dopamine-producing neurons degenerate, leading to motor symptoms. Levodopa crosses the blood-brain barrier and is converted to dopamine by aromatic amino acid decarboxylase (AADC). Carbidopa is a decarboxylase inhibitor that cannot cross the blood-brain barrier, so it blocks peripheral conversion of levodopa to dopamine, reducing side effects and increasing the amount of levodopa available for central nervous system conversion. The controlled-release formulation extends drug delivery over time to maintain more stable dopamine levels.
Approved indications
- Parkinson's disease
- Parkinsonism secondary to carbon monoxide poisoning or manganese intoxication
Common side effects
- Dyskinesia
- Motor fluctuations
- Nausea
- Orthostatic hypotension
- Hallucinations
- Confusion
- Insomnia
Key clinical trials
- A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants (PHASE1)
- Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (PHASE3)
- A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations (PHASE3)
- Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease
- Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations (PHASE2)
- Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease (PHASE4)
- Research on Translational Outcomes of Alcohol (Project RETRO) (PHASE4)
- A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations (PHASE3)
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:
- controlled-release levodopa / carbidopa CI brief — competitive landscape report
- controlled-release levodopa / carbidopa updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about controlled-release levodopa / carbidopa
What is controlled-release levodopa / carbidopa?
How does controlled-release levodopa / carbidopa work?
What is controlled-release levodopa / carbidopa used for?
Who makes controlled-release levodopa / carbidopa?
What drug class is controlled-release levodopa / carbidopa in?
What development phase is controlled-release levodopa / carbidopa in?
What are the side effects of controlled-release levodopa / carbidopa?
What does controlled-release levodopa / carbidopa target?
Related
- Drug class: All Dopamine precursor with peripheral decarboxylase inhibitor drugs
- Target: All drugs targeting Aromatic amino acid decarboxylase (AADC); dopamine pathway
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Parkinson's disease
- Indication: Drugs for Parkinsonism secondary to carbon monoxide poisoning or manganese intoxication
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing