Overview
Overactive bladder (OAB) is a common condition negatively impacting the lives of millions of patients worldwide. Due to its urinary symptoms that include nocturia, urgency, and frequency, this condition causes social embarrassment and a poor quality of life. Oxybutynin, also marketed as Ditropan XL, is an anticholinergic medication used for the relief of overactive bladder symptoms that has been optimized for high levels of safety and efficacy since initial FDA approval in 1975. This drug relieves undesirable urinary symptoms, increasing the quality of life for patients affected by OAB. It is often used as first-line therapy for OAB.
Background
Overactive bladder (OAB) is a common condition negatively impacting the lives of millions of patients worldwide. Due to its urinary symptoms that include nocturia, urgency, and frequency, this condition causes social embarrassment and a poor quality of life. Oxybutynin, also marketed as Ditropan XL, is an anticholinergic medication used for the relief of overactive bladder symptoms that has been optimized for high levels of safety and efficacy since initial FDA approval in 1975. This drug relieves undesirable urinary symptoms, increasing the quality of life for patients affected by OAB. It is often used as first-line therapy for OAB.
Indication
Oxybutynin is indicated for the symptomatic treatment of overactive bladder, which causes urge urinary incontinence and frequency, and urgency. Oxybutynin may also be used for children aged 6 and above for the symptomatic management of detrusor muscle overactivity which has been found to be related to a neurological condition. Spina bifida is an example of a neurological condition in which oxybutynin may be used to control urinary symptoms. On occasion, oxybutynin may be used off-label to relieve bladder spasms associated with ureteral stents or urinary catheters.
Associated Conditions
- Bladder Spasms
- Detrusor Hyperreflexia
- Overactive Bladder Syndrome (OABS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/18 | Phase 3 | Not yet recruiting | Central Hospital, Nancy, France | ||
2024/12/17 | Phase 3 | Recruiting | |||
2023/12/26 | Phase 2 | Not yet recruiting | |||
2023/12/08 | Phase 1 | ENROLLING_BY_INVITATION | |||
2023/10/30 | Phase 3 | Recruiting | Reinier de Graaf Groep | ||
2023/09/22 | N/A | Active, not recruiting | |||
2022/12/05 | Phase 3 | Recruiting | |||
2022/09/22 | Phase 1 | Recruiting | |||
2021/11/01 | Phase 2 | Recruiting | Samantha Rodrigues Camargo Neves de Moura | ||
2021/10/29 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5728 | ORAL | 10 mg in 1 1 | 1/21/2010 | |
| Bryant Ranch Prepack | 71335-0519 | ORAL | 5 mg in 1 1 | 12/20/2019 | |
| American Health Packaging | 68084-610 | ORAL | 10 mg in 1 1 | 2/7/2023 | |
| A-S Medication Solutions | 50090-4307 | ORAL | 10 mg in 1 1 | 3/15/2023 | |
| Marlex Pharmaceuticals Inc | 10135-610 | ORAL | 10 mg in 1 1 | 12/12/2019 | |
| Physicians Total Care, Inc. | 54868-2157 | ORAL | 5 mg in 1 1 | 3/18/2013 | |
| Teva Pharmaceuticals USA, Inc. | 50111-456 | ORAL | 5 mg in 1 1 | 9/30/2015 | |
| Zydus Pharmaceuticals USA Inc. | 68382-255 | ORAL | 5 mg in 1 1 | 11/7/2023 | |
| Marlex Pharmaceuticals Inc | 10135-640 | ORAL | 5 mg in 1 1 | 10/30/2019 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-322 | ORAL | 15 mg in 1 1 | 5/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/15/2004 | ||
Authorised | 6/15/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OBUTIN TABLETS 5 mg | SIN11215P | TABLET | 5 mg | 11/4/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Oxybutynin Hydrochloride Sustained Release Tablets | 国药准字H20040002 | 化学药品 | 片剂 | 6/5/2020 | |
| Oxybutynin Hydrochloride Tablets | 国药准字H10950165 | 化学药品 | 片剂 | 12/27/2019 | |
| Oxybutynin Hydrochloride Tablets | 国药准字H19990121 | 化学药品 | 片剂 | 2/3/2021 | |
| Oxybutynin Hydrochloride Oral Solution | 国药准字H20040491 | 化学药品 | 口服溶液剂 | 2/12/2020 | |
| 盐酸奥昔布宁缓释胶囊 | 国药准字H20090130 | 化学药品 | 胶囊剂 | 6/5/2024 |
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 |
|---|---|---|---|---|---|
| OXYTROL oxybutynin 3.9 mg/day transdermal drug delivery system | 125489 | Medicine | A | 5/10/2007 | |
| OXYBUTYNIN ARW oxybutynin hydrochloride 5 mg tablet bottle | 301918 | Medicine | A | 4/12/2019 | |
| OXYBUTYNIN TIH oxybutynin hydrochloride 5 mg tablet bottle | 301919 | Medicine | A | 4/12/2019 | |
| OXYBUPAN oxybutynin hydrochloride 5 mg tablet bottle | 301920 | Medicine | A | 4/12/2019 | |
| DITROPAN oxybutynin hydrochloride 5mg tablet | 48965 | Medicine | A | 5/30/1994 |