Overview
Benztropine, with the chemical formula 3alpha-diphenylmethoxytropane, is a tropane-based dopamine inhibitor used for the symptomatic treatment of Parkinson's disease. It is a combination molecule between a tropane ring, similar to cocaine, and a diphenyl ether from the dialkylpiperazines determined to be a dopamine uptake inhibitor since 1970. The generation of structure-activity relationships proved that benztropine derivatives with the presence of a chlorine substituent in the para position in one of the phenyl rings produces an increased potency for dopamine uptake inhibition as well as a decreased inhibition of serotonin and norepinephrine. Benztropine was developed by USL Pharma and officially approved by the FDA on 1996.
Indication
用于治疗帕金森病。也用于药物引起的锥体外系疾患，口服1小时起效，肌肉或静脉注射数分钟内起效，作用持续24小时。具有抗胆碱及抗组胺作用，并有轻度局部麻醉作用。
Associated Conditions
- Parkinsonism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/01 | Phase 1 | Recruiting | |||
2024/01/30 | Phase 4 | Recruiting | Aarhus University Hospital | ||
2023/09/13 | N/A | ENROLLING_BY_INVITATION | |||
2023/06/02 | Phase 2 | Recruiting | |||
2022/05/19 | Phase 1 | Completed | |||
2022/04/11 | Phase 3 | Recruiting | |||
2022/03/10 | Phase 2 | UNKNOWN | Peking University Cancer Hospital & Institute | ||
2021/07/12 | Not Applicable | Completed | |||
2020/12/28 | Phase 1 | Completed | |||
2019/12/09 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 43353-913 | ORAL | 0.5 mg in 1 1 | 5/21/2014 | |
| TYA Pharmaceuticals | 64725-0012 | INTRAVENOUS, INTRAMUSCULAR | 1 mg in 1 mL | 8/10/2012 | |
| Contract Pharmacy Services-PA | 67046-207 | ORAL | 1 mg in 1 1 | 12/19/2018 | |
| Par Pharmaceutical, Inc. | 0603-2439 | ORAL | 2 mg in 1 1 | 3/27/2023 | |
| Marlex Pharmaceuticals Inc | 10135-608 | ORAL | 2 mg in 1 1 | 5/17/2019 | |
| Marlex Pharmaceuticals Inc | 10135-607 | ORAL | 1 mg in 1 1 | 5/17/2019 | |
| Bryant Ranch Prepack | 63629-2135 | ORAL | 2 mg in 1 1 | 1/11/2024 | |
| Bayshore Pharmaceuticals LLC (NJ) | 76385-103 | ORAL | 0.5 mg in 1 1 | 3/14/2019 | |
| Cipla USA Inc. | 69097-827 | ORAL | 1 mg in 1 1 | 12/11/2018 | |
| Major Pharmaceuticals | 0904-6789 | ORAL | 2 mg in 1 1 | 8/8/2019 |
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 |
|---|---|---|---|---|---|
| BENZATROPINE PHEBRA SOLUTION FOR INJECTION 2 MG/2 ML | SIN16222P | INJECTION, SOLUTION | 2.0 mg/2ml | 6/3/2021 | |
| APO-BENZTROPINE TABLET 2 mg | SIN05894P | TABLET | 2 mg | 5/22/1991 |
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 |
|---|---|---|---|---|---|
| BENZTROPINE MESILATE SOLUTION FOR INJECTION 2MG/2ML | N/A | N/A | N/A | 3/21/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Benzatropine Injection | 320907 | Medicine | A | 7/26/2019 | |
| BENZTROP benztropine mesilate 2mg tablet bottle | 83130 | Medicine | A | 7/15/2002 | |
| BENZATROPINE INJECTION benzatropine mesilate 2mg in 2 mL, vial | 276242 | Medicine | A | 7/18/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PDP-BENZTROPINE | pendopharm division of pharmascience inc | 02219727 | Solution - Oral | 2 MG / 5 ML | 8/20/1997 |
| BENZTROPINE 2 TAB 2MG | PRO DOC LIMITEE | 00563862 | Tablet - Oral | 2 MG | 12/31/1982 |
| PDP-BENZTROPINE | pendopharm division of pharmascience inc | 00426857 | Tablet - Oral | 2 MG | 12/31/1978 |
| PMS-BENZTROPINE 2MG/TAB | 00587265 | Tablet - Oral | 2 MG | 12/31/1984 | |
| BENSYLATE TAB 2MG | icn canada ltd. | 00428086 | Tablet - Oral | 2 MG | 12/31/1978 |
| BENZTROPINE MESYLATE INJECTION, USP | sabex inc | 02243121 | Liquid - Intravenous
,
Intramuscular | 1 MG / ML | N/A |
| PDP-BENZTROPINE | pendopharm division of pharmascience inc | 00706531 | Tablet - Oral | 1 MG | 12/31/1987 |
| DOM-BENZTROPINE | dominion pharmacal | 02241791 | Tablet - Oral | 2 MG | N/A |
| COGENTIN TAB 2MG | merck frosst canada & cie, merck frosst canada & co. | 00016357 | Tablet - Oral | 2 MG | 12/31/1954 |
| PMS-BENZTROPINE TAB 0.5MG | 00885452 | Tablet - Oral | 0.5 MG | 12/31/1990 |
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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