Drugs / Rasagiline
last change May 2026 re-read 9 days ago

Rasagiline

Small molecule targets MAOB via inhibition

Developed for
Parkinson disease · amyotrophic lateral sclerosis · Alzheimer disease · brain injury · depressive disorder · multiple system atrophy · REM sleep behavior disorder · retinal detachment
+4 more · sleep disorder, initiating and maintaining sleep · progressive supranuclear palsy · restless legs syndrome · schizophrenia
Investigated by
Teva Branded Pharmaceutical Products R&D, Inc. · H. Lundbeck A/S · Takeda · Bial - Portela C S.A. · Pharma Two B Ltd. · Technical University Dresden
+51 more · Teva Neuroscience, Inc. · Beijing Bionovo Medicine Development Co., Ltd. · Beijing Tiantan Hospital · Brown University · CHU Purpan (Toulouse) · Celgene Corporation · Centre Hospitalier Universitaire, Amiens · Centre Hospitalier de la côte Basque · Centre Hospitalier du Pays d'Aix · Chongqing Fortune Pharmaceutical Co., Ltd. · Eisai Inc. · Fondation Rothschild Paris · Fujian Medical University Union Hospital · Guizhou Medical University · Huashan Hospital · Hôpital Dupuytren · Hôpital Haut-Lévêque · Hôpital de la Timone (MARSEILLE) · Insel Gruppe AG, University Hospital Bern · International Brain Research Foundation · Jiangsu Province Nanjing Brain Hospital · Lundbeck Italia S.p.A. · Merck Sharp & Dohme LLC · National Institute of Neurological Disorders and Stroke (NINDS) · Nîmes University Hospital · Poitiers University Hospital · Qilu Hospital of Shandong University · Qualissima · Rennes University Hospital · Richard Barohn, MD · Sant Pau Research Institute · Second Affiliated Hospital of Soochow University · Second Affiliated Hospital, School of Medicine, Zhejiang University · Sir Run Run Shaw Hospital · Teva Pharmaceuticals USA · The Affiliated Hospital of Hangzhou Normal University · The First Affiliated Hospital of Anhui Medical University · The First Affiliated Hospital of Dalian Medical University · The First Affiliated Hospital of Guangzhou Medical University · University Hospital of Saint-Etienne · University Hospital, Caen · University Hospital, Clermont-Ferrand · University Hospital, Lille · University Hospital, Rouen · University of British Columbia · University of Florida · University of Ulm · West China Hospital · Western ALS Study Group · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Yunxia Wang, MD

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed Parkinson disease 3 milestones
Filed Japan (PMDA) — Parkinson disease 2017-06-29

“has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for rasagiline mesylate” takeda.com ↗

Filed EU (EMA) — Parkinson disease 2003-10-12

“the rasagiline regulatory file has been submitted to the European Agency for Evaluation of Medicinal Products (EMEA) for the treatment of Parkinson's disease” tevapharm.com ↗

Filed US (FDA) — Parkinson disease 2003-09-08

“submitted to the US Food and Drug Administration (FDA) a New Drug Application (NDA) for rasagiline for the treatment of Parkinson's disease” tevapharm.com ↗

Approved Indication not stated 3 milestones
Label expansions (2) US (FDA) AZILECT — 2009-12-09 – 2014-05-29 fda.gov ↗
Approved US (FDA) AZILECT — 2006-05-16 fda.gov ↗
Approved EU (EMA) Azilect — 2005-02-21 europa.eu ↗

Trials 41

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04978298 Jul 2021 → Feb 2023 — Celgene Corporation Completed No outcome recorded
Phase 1 NCT01879748 Jun → Sep 2013 Parkinson disease Teva Branded Pharmaceutical Products R&D, Inc. Completed No outcome recorded
Phase 1 NCT01652313 May → Jun 2012 Parkinson disease H. Lundbeck A/S Completed No outcome recorded
Phase 1 NCT01532128 Nov 2009 → Feb 2010 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 1 NCT01532141 Nov 2009 → Feb 2010 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02696512 Mar 2016 → Mar 2017 brain injury International Brain Research Foundation Unknown No outcome recorded
Phase 26 trials · 3 missed
Phase 2 NCT02789020 Dec 2016 → May 2023 Parkinson disease University of Florida Completed No outcome recorded
Phase 2 NCT01786603 Nov 2013 → Jul 2016 amyotrophic lateral sclerosis Richard Barohn, MD Completed No outcome recorded
Phase 2 NCT01879241 Jun 2013 → Apr 2016 amyotrophic lateral sclerosis University of Ulm Completed Missed primary
Phase 2 NCT01232738 Dec 2011 → May 2013 amyotrophic lateral sclerosis Yunxia Wang, MD Completed Missed primary
Phase 2 NCT00977665 Dec 2009 → Oct 2011 multiple system atrophy Teva Branded Pharmaceutical Products R&D, Inc. Completed Missed primary
Phase 2 NCT00104273 Aug 2004 → Mar 2007 Alzheimer disease Teva Branded Pharmaceutical Products R&D, Inc. Completed No outcome recorded
Phase 2/33 trials · 2 met primary
Phase 2/3 NCT05611372 Jan 2023 → Dec 2025 Parkinson disease, REM sleep behavior disorder, synucleinopathy Second Affiliated Hospital, School of Medicine, Zhejiang University Withdrawn No outcome recorded Stop: Enrollment
Phase 2/3 NCT02337738 Jan 2015 → Sep 2016 Parkinson disease Takeda Completed Met primary
Phase 2/3 NCT01968460 Dec 2013 → May 2015 Parkinson disease Pharma Two B Ltd. Completed Met primary
Phase 315 trials · 4 met primary · 1 missed
Phase 3 NCT03329508 Jan 2018 → Aug 2021 Parkinson disease Pharma Two B Ltd. Completed Met primary
Phase 3 NCT02337751 Jul 2015 → Mar 2017 Parkinson disease Takeda Completed No outcome recorded
Phase 3 NCT02337725 Feb 2015 → Sep 2016 Parkinson disease Takeda Completed Met primary
Phase 3 NCT02337764 Feb 2015 → Sep 2016 Parkinson disease Takeda Completed No outcome recorded
Phase 3 NCT01556165 Apr 2012 → Dec 2013 Parkinson disease H. Lundbeck A/S Completed Met primary
Phase 3 NCT01479530 Dec 2011 → Jun 2013 Parkinson disease H. Lundbeck A/S Completed Met primary
Phase 3 NCT01736891 Nov 2011 → Jun 2013 Parkinson disease Chongqing Fortune Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT01268891 Jan 2011 → Jun 2012 Parkinson disease H. Lundbeck A/S Completed Missed primary
Phase 3 NCT01215227 Nov 2010 → Jul 2013 Parkinson disease Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT00256204 Nov 2005 → Apr 2008 Parkinson disease Teva Branded Pharmaceutical Products R&D, Inc. Completed Mixed
Phase 410 trials · 1 met primary · 1 missed
Phase 4 NCT01765257 Jun 2013 → Dec 2014 — University Hospital, Clermont-Ferrand Unknown No outcome recorded
Phase 4 NCT01723228 Nov 2012 → Jan 2015 Parkinson disease Teva Branded Pharmaceutical Products R&D, Inc. Completed Missed primary
Phase 4 NCT01442610 Oct 2011 → Mar 2015 Parkinson disease, sleep disorder, initiating and maintaining sleep Technical University Dresden Completed No outcome recorded
Phase 4 NCT01382342 Jun 2011 → Feb 2014 Parkinson disease Brown University Completed No outcome recorded
Phase 4 NCT02068625 Sep 2010 → Dec 2018 retinal detachment Insel Gruppe AG, University Hospital Bern Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT01055379 Mar 2010 → Jul 2012 Parkinson disease, depressive disorder Lundbeck Italia S.p.A. Completed No outcome recorded
Phase 4 NCT01049984 Dec 2009 → Oct 2012 Parkinson disease Teva Neuroscience, Inc. Completed Met primary
Phase 4 NCT00902941 May 2009 → Feb 2012 Parkinson disease Technical University Dresden Completed No outcome recorded
Phase 4 NCT01048229 Oct 2008 → Mar 2010 Parkinson disease Qualissima Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT00755027 Sep 2008 → Jun 2014 Parkinson disease Sant Pau Research Institute Completed No outcome recorded
Phase not applicable1 trial
— NCT02207387 Oct 2013 → Mar 2017 Parkinson disease University of British Columbia Unknown No outcome recorded
Comparator or background therapy16 trials
Phase 1 NCT06798519 Comparator May → Dec 2026 expected Parkinson disease Guangzhou Henovcom Bioscience Co. Ltd. Active not recruiting No outcome recorded
Phase 2 NCT02359552 Comparator May 2015 → Aug 2018 Alzheimer disease The Cleveland Clinic Completed No outcome recorded
Phase 2/3 NCT01192503 Comparator Sep 2010 → Jun 2012 restless legs syndrome University of Virginia Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT01155466 Comparator Jul 2010 → Dec 2012 Parkinson disease Merck Sharp & Dohme LLC Completed Missed primary
Phase 3 NCT01155479 Comparator Jul 2010 → Jul 2013 Parkinson disease Merck Sharp & Dohme LLC Terminated Missed primary Stop: Business

News releases announcing trial results or a regulatory action · 24

DateIssuerRelease
2017-06-29 Takeda Regulatory Takeda Submits a New Drug Application for Rasagiline Mesylate for the Treatment of Parkinson’s Disease in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE: 4502 ) today announced that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for rasagiline mesylate (generic name, development code: TVP-1012) for the treatment of Parkinson’s disease.
2014-06-09 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory FDA Approves Expanded Label for AZILECT® for Treatment Across All Stages of Parkinson’s Disease tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for AZILECT® (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs).
2013-03-20 Teva Branded Pharmaceutical Products R&D, Inc. Results New Data Show Azilect® (rasagiline tablets) Provided Clinical Benefit in Patients with Early Parkinson’s When Added to Sub-Optimally Controlled Patients on Dopamine Agonist Therapy tevapharm.com ↗
Results from the study demonstrated that the addition of Azilect 1mg/day provided a statistically significant improvement (Primary endpoint: treatment effect ± SE -2.4 ± 0.95 [95% CI -4.3,-0.5, p=0.012]) in total Unified Parkinson’s Disease Rating Scale (UPDRS) score (Parts I, II and III, version three) from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo.
2011-04-11 Teva Branded Pharmaceutical Products R&D, Inc. Results Teva Announces Presentation of New Data on Multiple Sclerosis and Parkinson's Disease Treatments at 2011 American Academy of Neurology Annual Meeting tevapharm.com ↗
A retrospective analysis of IMS Longitudinal Prescription data demonstrating that rasagiline is associated with significantly higher compliance and persistence rates than other antiparkinson therapies.
2010-08-05 Teva Branded Pharmaceutical Products R&D, Inc. Results TEMPO Extension Study Further Demonstrates the Benefits of Azilect® in Early Parkinson's Disease Patients tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and H. Lundbeck A/S (Lundbeck) today announced newly published long-term data on Azilect® (rasagiline tablets) from the TEMPO study and its open-label extension.
2010-04-19 Teva Branded Pharmaceutical Products R&D, Inc. Results ADAGIO Analysis Demonstrates that the Natural Progression of Clinical Symptoms in Parkinson's Disease May Be Slower in Earlier Stages tevapharm.com ↗
The placebo analyses demonstrated that the natural progression of clinical symptoms in PD may be slower in the earlier stages of disease development than was expected from previous findings.
2010-04-07 Teva Branded Pharmaceutical Products R&D, Inc. Results Teva to Present New Data on Multiple Sclerosis and Parkinson's Disease at the 62nd American Academy of Neurology Annual Meeting tevapharm.com ↗
The subgroup analyses provide further insight into the larger effect size seen for rasagiline in ADAGIO patients with greater severity of disease at baseline.
2009-12-14 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory FDA Approves Newly Revised Prescribing Information For Azilect® Reducing Medication And Food Restrictions tevapharm.com ↗
Teva Pharmaceutical Industries, Ltd. (NASDAQ:TEVA) today announced the U.S. Food and Drug Administration (FDA) approved the newly revised prescribing information for AZILECT® (rasagiline tablets) reducing medication and food restrictions.
2009-09-24 CEL-SCI Corporation Results Swine Flu Stocks Moving Markets at Mid Week cel-sci.com ↗
They demonstrated that Parkinson's disease patients receiving AZILECT (rasagiline) 1mg/day at the start of the study experienced superior benefit over 18 months compared with those who started the exact same treatment nine months later.
2009-09-23 Teva Branded Pharmaceutical Products R&D, Inc. Results Results of ADAGIO Study with AZILECT® in Parkinson's Disease Published in New England Journal of Medicine tevapharm.com ↗
The ADAGIO study also confirmed the positive symptomatic effect and safety profile of AZILECT®, in line with prior studies.
2009-04-22 Teva Branded Pharmaceutical Products R&D, Inc. Results Teva to Present New Data on its Innovative Therapies for Multiple Sclerosis and Parkinson's Disease at the Upcoming 2009 American Academy of Neurology Annual Meeting tevapharm.com ↗
New information on the treatment of Parkinson's disease (PD) with AZILECT® (rasagiline tablets) include endpoints from the ADAGIO study; data demonstrating selectivity of MAO-B inhibition at maximum recommended dosing and the affect of treatment on non-motor symptoms in patients with early disease.
2008-11-03 Teva Branded Pharmaceutical Products R&D, Inc. Results Azilect® Shown To Be A Selective Mao-B Inhibitor tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results of a study in which Azilect® (rasagiline tablets) demonstrated selective MAOB inhibition at the approved dose of 1mg.

All press releases naming this drug 37 releases

DateIssuerRelease

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 59 sources stand behind the page.

FieldValueCited text
Known as Rasagiline “Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗
52

“Rasagiline is a monoamine oxidase B inhibitor with demonstrated efficacy and safety in patients with Parkinson's disease (PD).” PMID 30689042 ↗ Jan 2019

“Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea” NCT01268891 ↗

“Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B.” NCT01765257 ↗

“Participants will receive rasagiline once daily (QD) for 14 days from Days 59 to 72.” NCT04978298 ↗

“Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline” NCT00902941 ↗

“Rasagiline” NCT01268891 ↗

NCT00203138 ↗

NCT01382342 ↗

NCT01048229 ↗

NCT00696215 ↗

Show 42 more sources

Known as Agilect ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as AGN-1135 ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Azilect “introduction of Azilect (Rasagiline) therapy was associated with a significant improvement of PD patients' emotional expressiveness” NCT01385735 ↗
5

“Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea” NCT01268891 ↗

“Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment” NCT02068625 ↗

“AZILECT® (Rasagiline Tablet)” NCT06798519 ↗

NCT02207387 ↗

NCT01479530 ↗

Known as Azilect (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate) “Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate)” NCT01723228 ↗
Known as NSC-759639 ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Rasagilina ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Rasagiline (as mesilate) ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Rasagiline hemitartrate ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Rasagiline mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as rasagiline mesylate “rasagiline mesylate 1 mg oral once daily” NCT00203164 ↗
1

“Drug: rasagiline mesylate” NCT00977665 ↗

Known as Rasagiline mylan ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Rasagiline ratiopharm ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as RASAGILINE TARTRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as Rasagline ratiopharm ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as TV-1030 ChEMBL registry synonym — accepted as the source's own label CHEMBL887 ↗
Known as TVP-1012 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02337725 ↗
2

NCT02337764 ↗

NCT02337738 ↗

Action Inhibit “the largest placebo-controlled clinical trial of the monoamine oxidase B inhibitor, rasagiline” PMID 27190009 ↗ May 2016
Modality Small molecule — CHEMBL887 ↗
Route Oral “0.5 mg rasagiline mesylate oral once daily” NCT00203034 ↗
Target MAOB “Rasagiline mesylate was developed as a selective and irreversible MAO-B- inhibitor” NCT01442610 ↗