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.
Background
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 |
|---|---|---|---|---|---|
| Selegiline Hydrochloride Tablets | 国药准字H20113448 | 化学药品 | 片剂 | 2/24/2022 | |
| Selegiline Hydrochloride Tablets | 国药准字HJ20160342 | 化学药品 | 片剂 | 11/17/2020 | |
| Selegiline Hydrochloride Tablets | 国药准字H20234721 | 化学药品 | 片剂 | 3/6/2024 | |
| Selegiline Hydrochloride Tablets | 国药准字H20133055 | 化学药品 | 片剂 | 2/1/2023 | |
| Selegiline Hydrochloride Capsules | 国药准字H20090217 | 化学药品 | 胶囊剂 | 9/27/2023 |
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 |