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Trospium

Generic Name
Trospium
Brand Names
Trosec
Drug Type
Small Molecule
Chemical Formula
C25H30NO3
CAS Number
47608-32-2
Unique Ingredient Identifier
T4Y8ORK057

Overview

Trospium is an antispasmodic agent used to treat the symptoms of overactive bladder, a condition that causes the bladder muscles to contract uncontrollably. An overactive bladder leads to an increased urge to urinate, frequent urination, and sometimes, loss of control over urination. Trospium is manufactured by Indevus Pharmaceutical Inc. and was granted FDA approval in 2007.

Background

Trospium is an antispasmodic agent used to treat the symptoms of overactive bladder, a condition that causes the bladder muscles to contract uncontrollably. An overactive bladder leads to an increased urge to urinate, frequent urination, and sometimes, loss of control over urination. Trospium is manufactured by Indevus Pharmaceutical Inc. and was granted FDA approval in 2007.

Indication

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, detrusor instability and frequency of micturition.

Associated Conditions

  • Overactive Bladder Syndrome (OABS)

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2024/09/19
Phase 3
Recruiting
Karuna Therapeutics
2024/08/27
Phase 3
Completed
Karuna Therapeutics
2024/04/04
Phase 4
Completed
2023/11/13
Phase 3
Active, not recruiting
Karuna Therapeutics
2023/08/08
Phase 3
Recruiting
Karuna Therapeutics
2023/05/30
Early Phase 1
Active, not recruiting
2022/08/23
Phase 3
Recruiting
Karuna Therapeutics
2020/01/13
Phase 4
Recruiting
Becky Clarkson
2018/10/17
Not Applicable
Suspended
2018/07/27
N/A
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Aphena Pharma Solutions - Tennessee, LLC
71610-812
ORAL
20 mg in 1 1
4/2/2024
Bryant Ranch Prepack
63629-8457
ORAL
20 mg in 1 1
12/11/2021
Padagis US LLC
0574-0118
ORAL
60 mg in 1 1
11/22/2021
35573
35573-446
ORAL
60 mg in 1 1
1/31/2023
Actavis Pharma, Inc.
0591-3636
ORAL
60 mg in 1 1
8/1/2014
Granules Pharmaceuticals Inc.
70010-027
ORAL
60 mg in 1 1
7/28/2023
Bryant Ranch Prepack
72162-1108
ORAL
20 mg in 1 1
10/9/2023
Bryant Ranch Prepack
63629-8458
ORAL
60 mg in 1 1
11/22/2021
Exelan Pharmaceuticals Inc.
76282-336
ORAL
20 mg in 1 1
12/3/2018
Chartwell RX, LLC
62135-742
ORAL
20 mg in 1 1
8/25/2023

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
Licence No.
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Registration Date
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TGA Drug Approvals

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No TGA approvals found for this drug.
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