Overview
Tropisetron is an indole derivative with antiemetic activity. As a selective serotonin receptor antagonist, tropisetron competitively blocks the action of serotonin at 5HT3 receptors, resulting in suppression of chemotherapy- and radiotherapy-induced nausea and vomiting. Tropisetron appears to be well tolerated with the most frequently reported adverse effect being headache. Extrapyramidal side effects are rare upon using tropisetron.
Background
Tropisetron is an indole derivative with antiemetic activity. As a selective serotonin receptor antagonist, tropisetron competitively blocks the action of serotonin at 5HT3 receptors, resulting in suppression of chemotherapy- and radiotherapy-induced nausea and vomiting. Tropisetron appears to be well tolerated with the most frequently reported adverse effect being headache. Extrapyramidal side effects are rare upon using tropisetron.
Indication
For the prevention of nausea and vomiting induced by cytotoxic therapy and postoperative.
Associated Conditions
- Chemotherapy-Induced Nausea and Vomiting
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/10/03 | Phase 3 | Completed | Shantou University Medical College | ||
2022/09/09 | Phase 4 | Completed | |||
2019/12/11 | Phase 4 | UNKNOWN | Beijing Chao Yang Hospital | ||
2019/07/22 | Phase 4 | UNKNOWN | Beijing Chao Yang Hospital | ||
2015/12/09 | Not Applicable | Completed | |||
2015/10/15 | Phase 4 | UNKNOWN | Jun Zhu | ||
2015/06/23 | Not Applicable | UNKNOWN | Tianjin University of Traditional Chinese Medicine | ||
2014/03/26 | Not Applicable | Completed | |||
2013/07/10 | Phase 2 | UNKNOWN | |||
2012/07/10 | Phase 4 | 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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tropisetron Hydrochloride and Glucose Injection | 国药准字H20060662 | 化学药品 | 注射剂 | 9/22/2020 | |
| Tropisetron Hydrochloride and Glucose Injection | 国药准字H20050820 | 化学药品 | 注射剂 | 10/22/2020 | |
| Tropisetron Citrate Injection | 国药准字H20100061 | 化学药品 | 注射剂 | 3/17/2020 | |
| Tropisetron Mesylate Tablets | 国药准字H20020563 | 化学药品 | 片剂 | 12/23/2020 | |
| Tropisetron Hydrochloride Oral Solution | 国药准字H20080660 | 化学药品 | 口服溶液剂 | 8/1/2023 | |
| Tropisetron Hydrochloride for Injection | 国药准字H20060469 | 化学药品 | 注射剂 | 4/28/2021 | |
| Tropisetron Hydrochloride for Injection | 国药准字H20060470 | 化学药品 | 注射剂 | 4/28/2021 | |
| Tropisetron Hydrochloride for Injection | 国药准字H20060460 | 化学药品 | 注射剂（冻干粉针剂） | 2/20/2021 | |
| Tropisetron Hydrochloride for Injection | 国药准字H20060646 | 化学药品 | 注射剂 | 10/22/2020 | |
| Tropisetron Hydrochloride for Injection | 国药准字H20060287 | 化学药品 | 注射剂 | 11/23/2020 |
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 |
|---|---|---|---|---|---|
| TROPISETRON-AFT tropisetron (as hydrochloride) 5 mg/5 mL solution for injection ampoule | 189944 | Medicine | A | 11/16/2012 | |
| TROPISETRON MYX tropisetron (as hydrochloride) 2 mg/2 mL solution for injection or infusion ampoules | 246633 | Medicine | A | 4/28/2016 | |
| TROPISETRON-AFT tropisetron (as hydrochloride) 2 mg/2 mL solution for injection ampoule | 189943 | Medicine | A | 11/16/2012 |