MedPath

Benzatropine

Generic Name
Benzatropine
Brand Names
Cogentin
Drug Type
Small Molecule
Chemical Formula
C21H25NO
CAS Number
86-13-5
Unique Ingredient Identifier
1NHL2J4X8K

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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