Azilect

(Rasagiline)

ApprovedSmall molecule

Rasagiline is used to treat Parkinson's disease symptoms by increasing certain brain chemicals that help reduce tremors, stiffness, and movement problems associated with this neurological condition. It can be used alone or combined with other Parkinson's medications.[2] Azilect is currently approved and in use across 13 indications[4].[1]

Azilect is one of 354 small molecule programs targeting Fatigue. It is currently in Approved.

Indications

Total Trials

Active Trials

353

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cognitive ImpairmentActive, not recruiting

Retinal DetachmentActive, not recruiting

Skin CancerActive, not recruiting

Restless Legs SyndromeActive, not recruiting

Alzheimer DiseaseApproved

Parkinson DiseaseActive, not recruiting

Executive FunctionActive, not recruiting

CognitionActive, not recruiting

Progressive Supranuclear PalsyActive, not recruiting

ApathyActive, not recruiting

Cognitive ImpairmentApproved

Active, not recruiting

Retinal DetachmentApproved

Active, not recruiting

Skin CancerPreclinical

Active, not recruiting

Restless Legs SyndromePhase 2

Active, not recruiting

Alzheimer DiseaseApproved

Approved

Parkinson DiseaseApproved

Active, not recruiting

Executive FunctionApproved

Active, not recruiting

CognitionApproved

Active, not recruiting

Progressive Supranuclear PalsyPhase 3

Active, not recruiting

ApathyApproved

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Azilect

Teva

Approved

1 2

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Zocor

OOrganon and Co

Preclinical

6 6

Depakote

Ibrance

Lunesta

3 9

Permax

VValeant Pharmaceuticals

Preclinical

1 10

Luvox

SSolvay Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Parkinson's Disease12 trials

Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease

Completed· Teva logo

Teva·Phase 4·NCT01049984·328 enrolled

Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Withdrawn·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2/3·NCT05611372

The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease

Unknown status·IIstanbul University·Phase 4·NCT00696215·40 enrolled

Show 9 more trials

Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease

Terminated·UUniversity of Zurich·Phase 4·NCT01178047·1 enrolled

Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT01556165·130 enrolled

Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease

Terminated·QQualissima·Phase 4·NCT01048229·112 enrolled

Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease

Completed·TTechnische Universität Dresden·Phase 4·NCT01442610·30 enrolled

Image Parkinson's Disease Progression Study

Completed·UUniversity of Florida·Phase 2·NCT02789020·96 enrolled

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

Withdrawn·NNew York Medical College·Phase 4·NCT07077187

A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01155466·778 enrolled

Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.

Completed·SState University of New York at Buffalo··NCT02278588·45 enrolled

Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations

Completed·CChongqing Fortune Pharmaceutical Co., Ltd.·Phase 3·NCT01736891·268 enrolled

Amyotrophic Lateral Sclerosis3 trials

Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Completed·—·Phase 2·NCT01786603·80 enrolled

Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)

Completed·—·Phase 2·NCT01232738·36 enrolled

Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

Completed·UUniversity of Ulm·Phase 2·NCT01879241·252 enrolled

Tics3 trials

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline

Completed· Teva logo

Teva·Phase 1·NCT01879748·64 enrolled

Effect of BIA 9-1067 on Rasagiline Pharmacokinetics

Completed·BBial - Portela C S.A.·Phase 1·NCT01532128·24 enrolled

Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

Completed·BBial - Portela C S.A.·Phase 1·NCT01532141·25 enrolled

Parkinson's2 trials

A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients

Unknown status·TThe Parkinson's Institute·Phase 4·NCT01007630·36 enrolled

A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

Completed·PPharma Two B Ltd.·Phase 3·NCT03329508·544 enrolled

Cognition2 trials

Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

Completed· Teva logo

Teva·Phase 4·NCT01723228·170 enrolled

The Effect of Rasagiline on Cognition in Parkinson's Disease

Completed·—·Phase 4·NCT01382342·50 enrolled

16 more indications

Retinal Detachment1 trial

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

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02068625·23 enrolled

Mild to Moderate Alzheimer's Disease1 trial

Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)

Completed· Teva logo

Teva·Phase 2·NCT00104273·376 enrolled

Fatigue1 trial

Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease

Completed·UUniversity of Florida·Phase 4·NCT01168596·30 enrolled

Cognitive impairment1 trial

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

Completed·GGeorgetown University·Phase 4·NCT01497652·34 enrolled

Executive Function1 trial

Emotion, Mood and Executive Function in Parkinson's Disease (PD)

Unknown status·SSt. Josef Hospital Bochum·Phase 4·NCT01385735·70 enrolled

Apathy1 trial

Rasagiline and Apathy in Parkinson's Disease

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT00755027·40 enrolled

Women1 trial

Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT01652313·12 enrolled

Depression1 trial

Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn

Completed· Lundbeck logo

Lundbeck·Phase 4·NCT01055379·121 enrolled

Restless Legs Syndrome1 trial

Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Terminated·UUniversity of Virginia·Phase 2/3·NCT01192503·52 enrolled

Alzheimer's Disease1 trial

Rasagiline Rescue in Alzheimer's Disease Clinical Trial

Completed·TThe Cleveland Clinic·Phase 2·NCT02359552·50 enrolled

ART1 trial

Azilect + Antidepressant Chart Review

Completed· Teva logo

Teva··NCT00955604·1,500 enrolled

Parkinson's Disease (PD)1 trial

A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01155479·1,022 enrolled

Schizophrenia1 trial

Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00492336·84 enrolled

Drug1 trial

Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"

Completed· Takeda logo

Takeda··NCT03727139·1,021 enrolled

Progressive Supranuclear Palsy1 trial

Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear Palsy

Terminated·—·Phase 3·NCT01187888·44 enrolled

Unspecified2 trials

An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01215227·839 enrolled

Relative Bioavailability Study of HNC364 Injectable Suspension

Not yet recruiting·GGuangzhou Henovcom Bioscience Co. Ltd.·Phase 1·NCT06798519·30 enrolled

Regulatory

FDA Approval Timeline[5]

May 16, 2006

AZILECT

NDA NDA021641

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Rasagiline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Azilect drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rasagiline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rasagiline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021641). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Azilect. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Monoamine Oxidase B Inhibitor; Monoamine Oxidase B Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Teva

Patent Landscape[6]

Patent Cliff

Dec 5, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7572834Dec 5, 2026

7815942Aug 27, 2027

Azilect

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Parkinson's Disease12 trials

Amyotrophic Lateral Sclerosis3 trials

Tics3 trials

Parkinson's2 trials

Cognition2 trials

Retinal Detachment1 trial

Mild to Moderate Alzheimer's Disease1 trial

Fatigue1 trial

Cognitive impairment1 trial

Executive Function1 trial

Apathy1 trial

Women1 trial

Depression1 trial

Restless Legs Syndrome1 trial

Alzheimer's Disease1 trial

ART1 trial

Parkinson's Disease (PD)1 trial

Schizophrenia1 trial

Drug1 trial

Progressive Supranuclear Palsy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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