ZELAPAR (selegiline hydrochloride) · BAUSCH
Zelapar is a monoamine oxidase type B (MAO-B) inhibitor indicated for the treatment of patients with Parkinson’s disease. It is used as an adjunct therapy for individuals currently receiving levodopa/carbidopa who are experiencing a deterioration in the quality of their response to that treatment. There is no evidence that the drug provides a beneficial effect when used without concurrent levodopa therapy. Its primary therapeutic role is to manage the decline in treatment efficacy for patients on established dopaminergic regimens.
How ZELAPAR Works
Selegiline acts as an irreversible inhibitor of monoamine oxidase (MAO), an enzyme that regulates the metabolic degradation of catecholamines and serotonin. At recommended doses, the drug is selective for MAO type B, which is the predominant form of the enzyme in the brain. By inhibiting MAO-B, the drug blocks the breakdown of dopamine, which may result in increased dopamine levels. Evidence also suggests the medication may work through additional mechanisms to increase dopaminergic activity.
Details
- Status
- Prescription
- First Approved
- 2006-06-14
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
ZELAPAR Approval History
What ZELAPAR Treats
1 indicationsZELAPAR is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
ZELAPAR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZELAPAR FDA Label Details
Indications & Usage
FDA Label (PDF)ZELAPAR is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see Clinical Studies ]. ZELAPAR, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.