Drugs / Selegiline
Selegiline
also known as
EMSAM · Selegiline Transdermal System · STS · Zelapar · Selegiline-hydrochloride · Selegiline-neuraxpharm
targets MAOB via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | EMSAM | — | 2014-09-10 | fda.gov ↗ |
| Approved | US (FDA) | SELEGILINE HYDROCHLORIDE | — | 1989-06-05 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00456976 | Apr → Sep 2007 | schizophrenia | Tabriz University | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07452692 | Aug → Oct 2026 expected | major depressive disorder | Corium Innovations, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07571824 | Mar → Jun 2026 | — | Corium Innovations, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05938517 | Jun → Oct 2021 | Meniere disease | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 1 | NCT00033072 | Sep 2001 → Oct 2002 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Unknown | No outcome recorded |
| Phase 1 | NCT00000337 | Nov 1994 → ? | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 29 trials · 2 missed | ||||||
| Phase 2 | NCT04586543 | May 2020 → Feb 2025 | castration-resistant prostate carcinoma, prostate adenocarcinoma | László Mangel | Unknown | No outcome recorded |
| Phase 2 | NCT01495195 | Feb 2012 → May 2013 | substance-related disorder | Midwest Biomedical Research Foundation | Completed | No outcome recorded |
| Phase 2 | NCT01330030 | Jul 2005 → Aug 2008 | nicotine dependence | Stanford University | Completed | Missed primary |
| Phase 2 | NCT00218517 | Mar 2005 → Jul 2007 | cannabis dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00129311 | Jul 2004 → Dec 2012 | nicotine dependence | Yale University | Completed | Missed primary |
| Phase 2 | NCT00000336 | Jan 1995 → Feb 1996 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000188 | Sep 1994 → Oct 1995 | cocaine dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00000201 | ? → Dec 2001 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00013585 | ? → Dec 2005 | HIV infectious disease, cognitive disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT01912391 | Oct 2012 → Mar 2015 | borderline personality disorder | Mood and Anxiety Research, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00285766 | Aug 2002 → Jul 2005 | major depressive disorder | Somerset Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00032929 | Mar 2001 → Dec 2002 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | Missed primary |
| Phase 46 trials · 1 met primary | ||||||
| Phase 4 | NCT04870372 | Mar → Dec 2020 | Parkinson disease | Second Affiliated Hospital of Soochow University | Completed | No outcome recorded |
| Phase 4 | NCT02225548 | Sep 2014 → Dec 2018 | Parkinson disease, erectile dysfunction | University of South Florida | Unknown | No outcome recorded |
| Phase 4 | NCT00531947 | Jul 2007 → Oct 2010 | major depressive disorder | Somerset Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00535262 | Mar 2007 → Feb 2012 | bipolar depression | New York State Psychiatric Institute | Terminated | No outcome recorded |
| Phase 4 | NCT00443872 | Mar 2007 → Sep 2008 | Parkinson disease | Parkinson's Disease and Movement Disorder Center of Boca Raton | Completed | Met primary |
| Phase 4 | NCT00640159 | Jan 2007 → Jun 2008 | Parkinson disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT04130087 | Sep 2019 → Sep 2020 | — | University of Oxford | Unknown | No outcome recorded |
| — | NCT00390923 | Jul 2007 → Apr 2008 | nicotine dependence | Centre for Addiction and Mental Health | Terminated | No outcome recorded |
| — | NCT00027040 | ? → Jun 2005 | HIV infectious disease, cognitive disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT00439413 Comparator | Jun 2007 → Aug 2008 | nicotine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 4 | NCT00532116 Comparator | Apr → Aug 2007 | — | Somerset Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00531596 Comparator | Apr → Jul 2007 | — | Somerset Pharmaceuticals | Completed | No outcome recorded |
| — | NCT00282152 Background | Mar 2006 → Jan 2012 | Parkinson disease | Vanderbilt University Medical Center | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Selegiline | “Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.” NCT00282152 ↗28“new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM” NCT00640159 ↗ |
| Known as | EMSAM | “The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is...” NCT07452692 ↗ |
| Known as | Selegiline Transdermal System | “OBJECTIVE: To assess the long-term safety (primary aim) and efficacy (secondary aim) of the MAO-B inhibitor Selegiline Transdermal System (STS) for the treatment of...” PMID 18042509 ↗ Nov 20071“Drug: Selegiline Transdermal System” NCT00531947 ↗ |
| Known as | Selegiline-hydrochloride | “Drug: Selegiline-hydrochloride” NCT05938517 ↗ |
| Known as | Selegiline-neuraxpharm | “Selegiline-neuraxpharm” NCT05938517 ↗ |
| Known as | STS | “OBJECTIVE: To assess the long-term safety (primary aim) and efficacy (secondary aim) of the MAO-B inhibitor Selegiline Transdermal System (STS) for the treatment of...” PMID 18042509 ↗ Nov 20071“This study examined the efficacy and safety of selegiline transdermal system (STS) and brief repeated behavioral intervention (BRBI) for smoking cessation in heavy smokers.” PMID 21846661 ↗ Aug 2011 |
| Known as | Zelapar | “new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM” NCT00640159 ↗1“orally disintegrating selegiline (Zelapar)” NCT00443872 ↗ |
| Action | Inhibit | “MAO-B inhibitor” PMID 18042509 ↗ Nov 2007 |
| Route | Other | “the selegiline transdermal system (STS)” PMID 19890073 ↗ Nov 2009 |
| Target | MAOB | “the irreversible MAO-B inhibitor selegiline” PMID 40932155 ↗ Oct 2025 |