Drugs / Rasagiline
Rasagiline
also known as
AZILECT · TVP-1012 · rasagiline mesylate · Agilect · AGN-1135 · Azilect (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate) · NSC-759639 · Rasagilina · +8 more
Small molecule targets MAOB via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | NCT01532141 | Nov 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01532128 | 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT01232738 | Dec 2011 → May 2013 | amyotrophic lateral sclerosis | Yunxia Wang, MD | Completed | No outcome recorded |
| Phase 2 | NCT00977665 | Dec 2009 → Oct 2011 | multiple system atrophy | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00104273 | Aug 2004 → Mar 2007 | Alzheimer disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| 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 |
| Phase 2/3 | NCT02337738 | Jan 2015 → Sep 2016 | Parkinson disease | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT01968460 | Dec 2013 → May 2015 | Parkinson disease | Pharma Two B Ltd. | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT03329508 | Jan 2018 → Aug 2021 | Parkinson disease | Pharma Two B Ltd. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01479530 | Dec 2011 → Jun 2013 | Parkinson disease | H. Lundbeck A/S | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00203138 | Jun 2004 → Nov 2006 | Parkinson disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00203164 | May 2002 → Jul 2005 | Parkinson disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00203177 | Oct 2001 → Dec 2006 | Parkinson disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00203034 | May 2000 → Jan 2003 | Parkinson disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00203060 | Jul 1997 → Jul 2000 | Parkinson disease | Teva Neuroscience, Inc. | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| 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 | No outcome recorded |
| 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 |
| 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 | No outcome recorded |
| 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 |
| 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 |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06798519 Comparator | May → Dec 2026 expected | Parkinson disease | Guangzhou Henovcom Bioscience Co. Ltd. | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02359552 Comparator | May 2015 → Aug 2018 | Alzheimer disease | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01192503 Comparator | Sep 2010 → Jun 2012 | restless legs syndrome | University of Virginia | Terminated | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01155466 Comparator | Jul 2010 → Dec 2012 | Parkinson disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01155479 Comparator | Jul 2010 → Jul 2013 | Parkinson disease | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01187888 Comparator | Jan 2010 → Jun 2012 | progressive supranuclear palsy | Prof. Dr. Stefan Lorenzl | Terminated | No outcome recorded |
| Phase 3 | NCT00203125 Background | Oct 2000 → Jan 2003 | Parkinson disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT07077187 Comparator | Sep 2014 → Jul 2017 | Parkinson disease | New York Medical College | Withdrawn | No outcome recorded |
| Phase 4 | NCT01497652 Comparator | Jan 2012 → Mar 2015 | Parkinson disease | Georgetown University | Completed | No outcome recorded |
| Phase 4 | NCT01385735 Comparator | Oct 2011 → Oct 2012 | Parkinson disease | St. Josef Hospital Bochum | Unknown | No outcome recorded |
| Phase 4 | NCT01178047 Comparator | Sep 2011 → Oct 2012 | Parkinson disease | University of Zurich | Terminated | No outcome recorded |
| Phase 4 | NCT01168596 Comparator | Dec 2009 → May 2012 | Parkinson disease | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT01007630 Comparator | Nov 2009 → Jan 2014 | Parkinson disease | The Parkinson's Institute | Unknown | No outcome recorded |
| Phase 4 | NCT00696215 Comparator | Jun 2007 → Jun 2008 | Parkinson disease | Istanbul University | Unknown | No outcome recorded |
| Phase 4 | NCT00492336 Comparator | Jan 2007 → Feb 2012 | schizophrenia | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT00399477 Comparator | Oct 2006 → Jul 2007 | Parkinson disease | Teva Neuroscience, Inc. | Completed | No outcome recorded |
Press releases naming this drug 31 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-06-29 | Takeda | Takeda Submits a New Drug Application for Rasagiline Mesylate for the Treatment of Parkinson’s Disease in Japan takeda.com ↗ |
| 2015-01-08 | Takeda | Phase 2/3 and 3 Clinical Trials of an Investigational Compound Rasagiline for the Treatment of Parkinson's Disease Start in Japan takeda.com ↗ |
| 2014-06-09 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Expanded Label for AZILECT® for Treatment Across All Stages of Parkinson’s Disease tevapharm.com ↗ |
| 2014-04-28 | Takeda | TEVA AND TAKEDA AGREE TO COMMERCIALIZE RASAGILINE FOR PARKINSON'S DISEASE TREATMENT IN JAPAN takeda.com ↗ |
| 2014-04-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Takeda Agree to Commercialize Rasagiline for Parkinson’s Disease Treatment in Japan tevapharm.com ↗ |
| 2013-09-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Favorable Court Ruling in AZILECT® Patent Infringement Litigation Against Mylan tevapharm.com ↗ |
| 2013-06-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces AZILECT® (Rasagiline Tablets) Data to Be Presented at the 2013 International Congress of Parkinson’s Disease and Movement Disorders tevapharm.com ↗ |
| 2013-03-20 | Teva Branded Pharmaceutical Products R&D, Inc. | 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 ↗ |
| 2013-02-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces First Patient Enrolled in Largest Clinical Study to Date Evaluating AZILECT® for Mild Cognitive Impairment in Parkinson's Disease tevapharm.com ↗ |
| 2012-06-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces AZILECT® (Rasagiline Tablets) Data to Be Presented at the 16th Annual International Congress of Parkinson’s Disease and Movement Disorders tevapharm.com ↗ |
| 2010-08-05 | Teva Branded Pharmaceutical Products R&D, Inc. | TEMPO Extension Study Further Demonstrates the Benefits of Azilect® in Early Parkinson's Disease Patients tevapharm.com ↗ |
| 2009-12-14 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Newly Revised Prescribing Information For Azilect® Reducing Medication And Food Restrictions tevapharm.com ↗ |
| 2009-09-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results of ADAGIO Study with AZILECT® in Parkinson's Disease Published in New England Journal of Medicine tevapharm.com ↗ |
| 2009-05-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Extension of Patent Protection for Azilect® tevapharm.com ↗ |
| 2008-11-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Azilect® Shown To Be A Selective Mao-B Inhibitor tevapharm.com ↗ |
| 2008-08-26 | Teva Branded Pharmaceutical Products R&D, Inc. | ADAGIO Trial Results Show Teva's Azilect® 1 Mg Tablets Slow Progression of Parkinson's Disease tevapharm.com ↗ |
| 2008-06-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva's AZILECT® 1 mg Tablets Meet End Points in ADAGIO Phase III Trial tevapharm.com ↗ |
| 2006-08-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Health Canada Approves Azilect® (Rasagiline) for Parkinson's Disease tevapharm.com ↗ |
| 2006-07-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Will Be Sole Promoter of Azilect® for Parkinson's Disease in the United States tevapharm.com ↗ |
| 2006-05-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Grants Approval of Azilect® (Rasagiline) for Parkinson's Disease tevapharm.com ↗ |
| 2005-08-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Follow-Up Approvable Letter from FDA Regarding Agilect® tevapharm.com ↗ |
| 2005-06-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva And Lundbeck Announce That Azilect (Rasagiline) For Parkinson's Disease Is Now Available In The United Kingdom tevapharm.com ↗ |
| 2005-02-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Lundbeck Announce European Approval for AZILECT® (rasagiline) 1mg for Parkinson's Disease tevapharm.com ↗ |
| 2005-01-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces That Azilect® (Rasagiline) Is Approved For Marketing In Israel tevapharm.com ↗ |
| 2004-11-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Lundbeck announce that Azilect® (rasagiline) for Parkinson's disease is recommended for approval in the EU tevapharm.com ↗ |
| 2004-07-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Approvable Letter For Agilect® (Rasagiline) tevapharm.com ↗ |
| 2003-10-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva And Lundbeck Announce European Submission Of Rasagiline As A Treatment For Parkinson's Disease tevapharm.com ↗ |
| 2003-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces NDA Submission of Rasagiline as a Treatment for Parkinson's Disease tevapharm.com ↗ |
| 2003-05-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Eisai Sign Agreement for Co-Development of Rasagiline for Alzheimer's Disease, and Co-Promotion for Parkinson's Disease, in the U.S. tevapharm.com ↗ |
| 2003-03-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva & Lundbeck Announce Successful Completion of Rasagiline Phase III Clinical Program in Parkinson's Disease tevapharm.com ↗ |
| 2003-01-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Clarifies Media Reports Regarding Rasagiline Status tevapharm.com ↗ |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 ↗ |
| 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 ↗ |
| 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 ↗ |