TheraRadar
Data updated: May 26, 2026

AZILECT (rasagiline mesylate)

Trial Activity: Declining
CNS Approved 2006-05-16

AZILECT is indicated for the treatment of Parkinson's Disease.

How AZILECT Works

Rasagiline functions as a potent and irreversible inhibitor of the MAO-B enzyme, which is the primary form of monoamine oxidase found in the human brain. By blocking this enzyme, the drug prevents the metabolic degradation of dopamine, leading to increased extracellular levels of the neurotransmitter in the striatum. This elevated dopaminergic activity is believed to mediate the drug's beneficial effects on motor function. While selective for MAO-B at recommended doses, this selectivity may decrease in a dose-related manner.

Development Insights

H. Lundbeck A/S conducting 2 trials (67%)
2 indications explored (Focused)
parkinson's disease (2 trials)
multiple system atrophy (1 trials)
3
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2006-05-16
Patent Cliff
2027

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: RASAGILINE MESYLATE

AZILECT Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
28 FDA actions from 2006 to 2020 · 1 indication expansions
Jun 2020 SUPPL
Label · Labeling
Dec 2018 SUPPL
Label · Labeling
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)

What AZILECT Treats

1 indications

AZILECT is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Parkinson's Disease
Source: FDA Label

AZILECT Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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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.

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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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Ongoing clinical trials by development phase

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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.

AZILECT FDA Label Details

Indications & Usage

FDA Label (PDF)

AZILECT is indicated for the treatment of Parkinson's Disease.

View full patent landscape →
2 OB patents · 2 families · 36 international docs across 16 countries

AZILECT Patents & Exclusivity

Latest Patent: Aug 2027

Patents (2 active)

US7815942 Expires Aug 27, 2027
US7572834 Expires Dec 5, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for AZILECT

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2027
  • 8 active patents

Trial Analysis

  • 3 total trials
  • Stage: Declining

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment