Back to discover
Drug

Rasagiline

Approved · EMA
Late-stage development
Also known as (1R)-N-propargylindan-1-amine, (R)-N-2-Propynyl-1-indanamine, (R)-indan-1-yl-prop-2-ynyl-amine, Azilect+2 more

(1R)-N-propargylindan-1-amine, (R)-N-2-Propynyl-1-indanamine, (R)-indan-1-yl-prop-2-ynyl-amine, Azilect, RAS, Rasagilina.

RxNorm134748ChEMBLCHEMBL887UNII003N66TS6T
1
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Relative Bioavailability Study of HNC364 Following Intramuscular Injections vs. AZILECT® (Rasagiline Tablet) Following Oral Administration at the Steady-State in Healthy Adult Subjects

Clinical trial2026-06-02Results expected Q4 2026 · ClinicalTrials.gov

Image Parkinson's Disease Progression Study

Clinical trial2023-09-06Results posted · ClinicalTrials.gov

A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

Clinical trial2023-03-21Results posted · ClinicalTrials.gov

A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

Clinical trial2021-11-09Results posted · ClinicalTrials.gov

A 24-week, Three-site, Randomized, Double Blind, Placebo Controlled, Parallel Group, Proof-of-concept Study to Evaluate Rasagiline in the Regional Brain Metabolism on FDG PET in Patients With Mild to Moderate Alzheimer's Disease

Clinical trial2020-11-10Results posted · ClinicalTrials.gov

Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis

Clinical trial2020-01-27Results posted · ClinicalTrials.gov

Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

Clinical trial2019-09-25Results posted · ClinicalTrials.gov

Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Clinical trial2018-12-31Terminated · ClinicalTrials.gov

A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)

Clinical trial2018-11-06Results posted · ClinicalTrials.gov

A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Clinical trial2018-05-18Results posted · ClinicalTrials.gov

Approval: Rasagiline ratiopharm (EMA)

Regulatory2015-01-12EMA

Approval: Azilect (EMA)

Regulatory2005-02-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Rasagiline
Aliases & brands
(1R)-N-propargylindan-1-amine(R)-N-2-Propynyl-1-indanamine(R)-indan-1-yl-prop-2-ynyl-amineAzilectRASRasagilina
RxNorm CUI
134748
ChEMBL ID
CHEMBL887
UNII
003N66TS6T
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2005-02-21
Latest approval
2015-01-12
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2015-01-12Approval
Approval: Rasagiline ratiopharm (EMA)
Indication: Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients… Show full indication

Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Evidence ↗
2005-02-21Approval
Approval: Azilect (EMA)
Indication: Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose… Show full indication

Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

36 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
36
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
25
Late-stage (III+)
23
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 36
Phase 15Phase 26Phase 2 / 32Phase 37Phase 416

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

TerminatedPH IVInsel Gruppe AG, University Hospital Bernn=232018

Effect of Rasagiline on Balance in Parkinson's Disease as Measured by Computerized Posturography

WithdrawnPH IVNew York Medical College2017

Effects of Rasagiline on Sleep Disturbances in PD: A Single Center, Randomized, Double-blind, Placebo run-in, Polysomnographic Clinical Phase IV Trial

CompletedPH IVTechnische Universität Dresdenn=302015

A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy

CompletedPH IVGeorgetown Universityn=342015

A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

CompletedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=1702015

Recent completions

Trials that read out recently, adding to the completed evidence base.

Image Parkinson's Disease Progression Study

CompletedPH IIUniversity of Floridan=962023

A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

CompletedPH IIIPharma Two B Ltd.n=5442021

A 24-week, Three-site, Randomized, Double Blind, Placebo Controlled, Parallel Group, Proof-of-concept Study to Evaluate Rasagiline in the Regional Brain Metabolism on FDG PET in Patients With Mild to Moderate Alzheimer's Disease

CompletedPH IIThe Cleveland Clinicn=502019

Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance

CompletedPH IIUniversity of Ulmn=2522016

Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis

CompletedPH IIRichard Barohn, MDn=802016

Effects of Rasagiline on Sleep Disturbances in PD: A Single Center, Randomized, Double-blind, Placebo run-in, Polysomnographic Clinical Phase IV Trial

CompletedPH IVTechnische Universität Dresdenn=302015
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.