Overview
Rasagiline is an irreversible inhibitor of monoamine oxidase and is used as a monotherapy in early Parkinson's disease or as an adjunct therapy in more advanced cases.
Background
Rasagiline is an irreversible inhibitor of monoamine oxidase and is used as a monotherapy in early Parkinson's disease or as an adjunct therapy in more advanced cases.
Indication
For the treatment of the signs and symptoms of idiopathic Parkinsons disease as initial monotherapy and as adjunct therapy to levodopa.
Associated Conditions
- Parkinson's Disease (PD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/09 | Not Applicable | Not yet recruiting | |||
2024/09/10 | N/A | Completed | |||
2024/06/14 | N/A | Completed | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | ||
2024/04/03 | Not Applicable | Recruiting | |||
2023/08/02 | N/A | Active, not recruiting | |||
2022/11/10 | Phase 2 | Withdrawn | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2021/05/06 | Phase 4 | Completed | Shanghai 10th People's Hospital | ||
2020/10/01 | Phase 4 | UNKNOWN | Shenzhen Second People's Hospital | ||
2020/08/25 | Phase 4 | Completed | Nan Chen,MD | ||
2018/11/01 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Neuroscience, Inc. | 68546-142 | ORAL | 0.5 mg in 1 1 | 8/22/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3061 | ORAL | 1 mg in 1 1 | 8/24/2023 | |
| AvKARE | 42291-779 | ORAL | 0.5 mg in 1 1 | 11/7/2023 | |
| Teva Neuroscience, Inc. | 68546-229 | ORAL | 1 mg in 1 1 | 8/22/2023 | |
| Micro Labs Limited | 42571-221 | ORAL | 1 mg in 1 1 | 12/6/2021 | |
| NorthStar RxLLC | 16714-771 | ORAL | 1 mg in 1 1 | 9/15/2020 | |
| Avet Pharmaceuticals Inc. | 23155-747 | ORAL | 1 mg in 1 1 | 10/25/2023 | |
| Avet Pharmaceuticals Inc. | 23155-746 | ORAL | 0.5 mg in 1 1 | 10/25/2023 | |
| Ascend Laboratories, LLC | 67877-260 | ORAL | 1 mg in 1 1 | 11/30/2021 | |
| AvKARE | 42291-780 | ORAL | 1 mg in 1 1 | 11/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/21/2005 | ||
Authorised | 1/12/2015 | ||
Authorised | 4/4/2016 | ||
Authorised | 2/21/2005 | ||
Authorised | 1/12/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AZILECT TABLET 1MG | SIN15291P | TABLET | 1 MG | 7/7/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rasagiline Mesylate Tablets | 国药准字H20243700 | 化学药品 | 片剂 | 5/15/2024 | |
| Rasagiline Mesylate Tablets | 国药准字H20243784 | 化学药品 | 片剂 | 5/21/2024 | |
| Rasagiline Mesylate Tablets | 国药准字H20243081 | 化学药品 | 片剂 | 1/23/2024 | |
| Rasagiline Mesylate Tablets | 国药准字HJ20170336 | 化学药品 | 片剂 | 3/1/2022 | |
| Rasagiline Mesylate Tablets | 国药准字H20243701 | 化学药品 | 片剂 | 5/15/2024 | |
| Rasagiline Mesylate Tablets | 国药准字H20244908 | 化学药品 | 片剂 | 9/19/2024 | |
| Rasagiline Mesylate Tablets | 国药准字HJ20240043 | 化学药品 | 片剂 | 6/18/2024 | |
| Rasagiline Mesylate Tablets | 国药准字H20233947 | 化学药品 | 片剂 | 7/25/2023 | |
| Rasagiline Mesylate Tablets | 国药准字H20244702 | 化学药品 | 片剂 | 8/20/2024 | |
| Rasagiline Mesylate Tablets | 国药准字HJ20170337 | 化学药品 | 片剂 | 3/1/2022 |
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 |
|---|---|---|---|---|---|
| RASAGILINE GPPL rasagiline mesilate 1 mg tablets, bottle | 285447 | Medicine | A | 1/23/2018 | |
| AKM RASAGILINE rasagiline (as mesilate) 1 mg tablet blister pack | 288240 | Medicine | A | 10/29/2018 | |
| AZIGILINE rasagiline mesilate 1 mg tablets, bottle | 285445 | Medicine | A | 1/23/2018 | |
| AZILECT rasagiline (as mesilate) 1 mg tablet blister pack | 170172 | Medicine | A | 2/6/2012 | |
| ASAGILINE rasagiline mesilate 1 mg tablets, blister | 285449 | Medicine | A | 1/23/2018 | |
| AZALINE rasagiline mesilate 1 mg tablets, bottle | 285452 | Medicine | A | 1/23/2018 | |
| RASAZILECT rasagiline mesilate1 mg tablets, bottle | 285451 | Medicine | A | 1/23/2018 | |
| AZILECT rasagiline (as mesilate) 1 mg tablet bottle | 172457 | Medicine | A | 2/6/2012 | |
| RASAGILINE LUPIN rasagiline (as mesilate) 1 mg tablet blister pack | 294915 | Medicine | A | 9/13/2018 | |
| RASAGILINE MYLAN rasagiline mesilate 1 mg tablets, blister | 285446 | Medicine | A | 1/23/2018 |