Overview
Drotaverine is an antispasmodic drug that works by inhibiting phosphodiesterase-4 (PDE4). It is a benzylisoquinoline derivative that is structurally related to papaverine, although it displays more potent antispasmodic activities than papaverine. Drotaverine has been used in the symptomatic treatment of various spastic conditions, such as gastrointestinal diseases, biliary dyskinesia, and vasomotor diseases associated with smooth muscle spasms. It also has been investigated in dysmenorrhea, abortion, and augmentation of labour. More recently, drotaverine gained attention in the treatment of benign prostatic hyperplasia, parainfluenza, and avian influenza viruses. Drotaverine is not approved by the FDA, European Medicines Agency, or Health Canada. It is approved for use in Thailand as oral tablets or intramuscular injections.
Background
Drotaverine is an antispasmodic drug that works by inhibiting phosphodiesterase-4 (PDE4). It is a benzylisoquinoline derivative that is structurally related to papaverine, although it displays more potent antispasmodic activities than papaverine. Drotaverine has been used in the symptomatic treatment of various spastic conditions, such as gastrointestinal diseases, biliary dyskinesia, and vasomotor diseases associated with smooth muscle spasms. It also has been investigated in dysmenorrhea, abortion, and augmentation of labour. More recently, drotaverine gained attention in the treatment of benign prostatic hyperplasia, parainfluenza, and avian influenza viruses. Drotaverine is not approved by the FDA, European Medicines Agency, or Health Canada. It is approved for use in Thailand as oral tablets or intramuscular injections.
Indication
Drotaverine is used to alleviate gastrointestinal and genitourinary smooth muscle spasms, such as cholecystitis and gallbladder disorders.
Associated Conditions
- Abdominal Pain caused by Gall Stones
- Abdominal Pain caused by Kidney Stones
- Muscle Spasms
- Spastic Pain
- Spastic Pain caused by Cystitis
- Spastic Pain caused by Funicular Nephritis
- Spastic Pain caused by Gallbladder disorders
- Spastic Pain caused by Physical Examination
- Spastic Pain caused by cholecysitis
- Spastic Pain of the Gastrointestinal Tract
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2012/07/12 | Phase 2 | Completed | |||
2010/11/09 | Phase 2 | UNKNOWN | |||
2008/08/08 | Phase 3 | Completed | |||
2006/02/16 | Phase 4 | Terminated |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Drotaverine Hydrochloride Tablets | 国药准字H20020296 | 化学药品 | 片剂 | 12/10/2019 | |
| Drotaverine Hydrochloride Tablets | 国药准字H20254367 | 化学药品 | 片剂 | 5/27/2025 | |
| Drotaverine Hydrochloride Injection | 国药准字H20253456 | 化学药品 | 注射剂 | 2/25/2025 | |
| Drotaverine Hydrochloride Injection | 国药准字H20254030 | 化学药品 | 注射剂 | 4/30/2025 | |
| Drotaverine Hydrochloride Injection | 国药准字H20253760 | 化学药品 | 注射剂 | 4/1/2025 | |
| Drotaverine Hydrochloride Injection | 国药准字H20249323 | 化学药品 | 注射剂 | 11/15/2024 | |
| Drotaverine Hydrochloride Injection | opella healthcare commercial ltd. | 国药准字HJ20170302 | 化学药品 | 注射剂 | 11/22/2021 |
| Drotaverine Hydrochloride Injection | 国药准字H20183353 | 化学药品 | 注射剂 | 8/10/2023 | |
| Drotaverine Hydrochloride Injection | 国药准字H20065923 | 化学药品 | 注射剂 | 3/1/2021 | |
| Drotaverine Hydrochloride Injection | sanofi-aventis private co. ltd. | 国药准字HJ20170303 | 化学药品 | 注射剂 | 11/22/2021 |
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. | |||||