TheraRadar
Data updated: May 26, 2026

RASAGILINE MESYLATE

CNS Approved 2013-07-01

RASAGILINE MESYLATE is indicated for the treatment of Parkinson's Disease.

Source: FDA Label • RISING

How RASAGILINE MESYLATE Works

Rasagiline acts as a selective and irreversible inhibitor of monoamine oxidase type B (MAO-B), an enzyme responsible for the metabolic degradation of catecholamines in the brain. By blocking this enzyme, the drug increases extracellular levels of dopamine in the striatum. This elevated dopamine level enhances dopaminergic activity, which is believed to mediate the drug's beneficial effects on motor function.

12
Indications
--
Phase 3 Trials
12
Years on Market

RASAGILINE MESYLATE Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
46 FDA actions from 2013 to 2025
May 2025 ORIGINAL
Update
Jun 2024 ORIGINAL
Update
Apr 2024 ORIGINAL
Update

What RASAGILINE MESYLATE Treats

1 indications

RASAGILINE MESYLATE is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Parkinson's Disease
Source: FDA Label

RASAGILINE MESYLATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RASAGILINE MESYLATE

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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00977665 results posted MSA-RAS-202 2009-014644-11 Ph 2 completed Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

RASAGILINE MESYLATE FDA Label Details

Indications & Usage

FDA Label (PDF)

RASAGILINE MESYLATE is indicated for the treatment of Parkinson's Disease.

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Full clinical data, patents, trials, and competitive landscape for rasagiline mesylate.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.