Overview
Propiverine is a widely used antimuscarinic drug with a mixed mode of action in the treatment of symptoms associated with overactive bladder (OAB) . Overactive bladder (OAB) is a chronic condition of the lower urinary tract characterized by urinary urgency, increased frequency of urination, and nocturia (frequent waking during the night to urinate). OAB has a negative impact on quality of life and may lead to leakage and inconvenient urinary accidents , . Overactive bladder syndrome affects millions of elderly individuals in the United States and shows equal prevalence in men and women. The impact of OAB on quality of life is sometimes devastating, especially to elderly patients with other medical conditions . Propiverine hydrochloride is a bladder detrusor muscle relaxant drug with dual antimuscarinic and calcium-modulating properties for the treatment of OAB .
Background
Propiverine is a widely used antimuscarinic drug with a mixed mode of action in the treatment of symptoms associated with overactive bladder (OAB) . Overactive bladder (OAB) is a chronic condition of the lower urinary tract characterized by urinary urgency, increased frequency of urination, and nocturia (frequent waking during the night to urinate). OAB has a negative impact on quality of life and may lead to leakage and inconvenient urinary accidents , . Overactive bladder syndrome affects millions of elderly individuals in the United States and shows equal prevalence in men and women. The impact of OAB on quality of life is sometimes devastating, especially to elderly patients with other medical conditions . Propiverine hydrochloride is a bladder detrusor muscle relaxant drug with dual antimuscarinic and calcium-modulating properties for the treatment of OAB .
Indication
Indicated for symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder (OAB) . Propiverine may also be used in patients with neurogenic bladder as a result of spinal cord injury .
Associated Conditions
- Urinary Incontinence (UI)
- Urinary Urgency
- Increased frequency of urination
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/19 | N/A | Active, not recruiting | Furkan Adem Canbaz | ||
2019/02/18 | Not Applicable | Completed | |||
2018/07/27 | N/A | Completed | |||
2014/11/19 | Phase 4 | Completed | |||
2013/12/31 | N/A | Completed | |||
2013/09/16 | Not Applicable | Completed | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | ||
2012/02/10 | Phase 3 | Completed | |||
2012/01/19 | Phase 3 | Completed | Lee's Pharmaceutical Limited | ||
2009/05/15 | Phase 4 | Completed | |||
2008/11/21 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Mictonorm 15mg Tablet | SIN13235P | TABLET, COATED | 15.000 mg | 2/22/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Propiverine Hydrochloride Tablets | 国药准字H20040163 | 化学药品 | 片剂 | 8/5/2020 | |
| Propiverine Hydrochloride Tablets | 国药准字H20120062 | 化学药品 | 片剂 | 12/23/2021 | |
| Propiverine Hydrochloride Tablets | 国药准字H20041851 | 化学药品 | 片剂 | 4/9/2020 | |
| Propiverine Hydrochloride Tablets | 国药准字H13023021 | 化学药品 | 片剂 | 4/13/2020 | |
| Propiverine Hydrochloride Modified Release Capsules | 国药准字HJ20170173 | 化学药品 | 胶囊剂 | 11/12/2024 | |
| Propiverine Hydrochloride Modified Release Capsules | 国药准字HJ20140799 | 化学药品 | 胶囊剂 | 11/12/2024 | |
| Propiverine Hydrochloride Modified Release Capsules | H20170173 | 化学药品 | 胶囊剂 | 4/13/2020 | |
| Propiverine Hydrochloride Modified Release Capsules | H20140799 | 化学药品 | 胶囊剂 | 11/15/2019 | |
| Propiverine Hydrochloride Modified Release Capsules | 国药准字J20171031 | 化学药品 | 胶囊剂 | 6/16/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||