Overview
A selective, irreversible inhibitor of Type B monoamine oxidase. It is used in newly diagnosed patients with Parkinson's disease. It may slow progression of the clinical disease and delay the requirement for levodopa therapy. It also may be given with levodopa upon onset of disability. (From AMA Drug Evaluations Annual, 1994, p385) The compound without isomeric designation is Deprenyl.
Indication
Monotherapy for initial treatment of Parkinson's disease, as well as an adjunct therapy in patients with a decreased response to levodopa/carbadopa. Also used for the palliative treatment of mild to moderate Alzheimer's disease and at higher doses, for the treatment of depression.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Major Depressive Disorder (MDD)
- Parkinson's Disease (PD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/05/03 | Phase 4 | Completed | Second Affiliated Hospital of Soochow University | ||
2020/10/14 | Phase 2 | Recruiting | László Mangel | ||
2019/10/17 | Not Applicable | UNKNOWN | |||
2014/08/26 | Phase 4 | UNKNOWN | |||
2013/07/31 | Phase 3 | Completed | |||
2011/12/19 | Phase 2 | Completed | Midwest Biomedical Research Foundation | ||
2011/04/06 | Phase 2 | Completed | |||
2008/03/21 | Phase 4 | Completed | |||
2007/09/26 | Phase 4 | Terminated | |||
2007/09/19 | Phase 4 | Completed | Somerset Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A2A Integrated Pharmaceuticals | 73141-006 | ORAL | 5 mg in 1 1 | 2/28/2024 | |
| Novitium Pharma LLC | 70954-504 | ORAL | 5 mg in 1 1 | 2/13/2021 | |
| Mylan Specialty L.P. | 49502-900 | TRANSDERMAL | 6 mg in 24 h | 5/15/2020 | |
| Proficient Rx LP | 71205-888 | ORAL | 5 mg in 1 1 | 4/1/2022 | |
| Carilion Materials Management | 68151-2649 | ORAL | 5 mg in 1 1 | 7/3/2011 | |
| Bausch Health US, LLC | 0187-0453 | ORAL | 1.25 mg in 1 1 | 6/1/2021 | |
| Golden State Medical Supply, Inc. | 60429-176 | ORAL | 5 mg in 1 1 | 12/27/2023 | |
| Mylan Specialty L.P. | 49502-901 | TRANSDERMAL | 9 mg in 24 h | 5/15/2020 | |
| A-S Medication Solutions | 50090-2918 | ORAL | 5 mg in 1 1 | 11/28/2018 | |
| Apotex Corp. | 60505-0055 | ORAL | 5 mg in 1 1 | 12/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SELEGOS TABLET 5 mg | SIN08681P | TABLET | 5 mg | 4/30/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ELDEPRYL selegiline hydrochloride 5 mg tablet | 47465 | Medicine | A | 1/18/1994 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NU-SELEGILINE | nu-pharm inc | 02230717 | Tablet - Oral | 5 MG | 5/28/1997 |
| PMS-SELEGILINE | 02238102 | Tablet - Oral | 5 MG | 6/4/1998 | |
| MYLAN-SELEGILINE | Mylan Pharmaceuticals ULC | 02231036 | Tablet - Oral | 5 MG | 4/9/1997 |
| ELDEPRYL - 5MG TAB | draxis health inc. | 02123312 | Tablet - Oral | 5 MG | 9/2/1997 |
| DOM-SELEGILINE | dominion pharmacal | 02238340 | Tablet - Oral | 5 MG | 9/17/1998 |
| SELEGILINE | aa pharma inc | 02230641 | Tablet - Oral | 5 MG | 2/13/1997 |
| SELEGILINE-5 | PRO DOC LIMITEE | 02231479 | Tablet - Oral | 5 MG | 3/25/1998 |
| TEVA-SELEGILINE | teva canada limited | 02068087 | Tablet - Oral | 5 MG | 12/31/1994 |
| MED SELEGILINE | medican pharma incorporated | 02237289 | Tablet - Oral | 5 MG | 6/30/1999 |
| SELEGILINE | pharmel inc | 02238319 | Tablet - Oral | 5 MG | 9/3/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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