Overview
A serotonin receptor (5HT-3 selective) antagonist that has been used as an antiemetic and antinauseant for cancer chemotherapy patients.
Background
A serotonin receptor (5HT-3 selective) antagonist that has been used as an antiemetic and antinauseant for cancer chemotherapy patients.
Indication
For the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy (including high dose cisplatin), postoperation, and radiation (including total body irradiation and daily fractionated abdominal radiation).
Associated Conditions
- Nausea and vomiting
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/08 | Not Applicable | ENROLLING_BY_INVITATION | Minia University | ||
2024/08/06 | Phase 4 | Recruiting | |||
2024/07/22 | Phase 4 | Not yet recruiting | |||
2024/05/31 | Not Applicable | Recruiting | |||
2024/02/28 | Phase 3 | Completed | |||
2023/12/19 | Not Applicable | Completed | |||
2023/09/11 | Phase 2 | Recruiting | |||
2023/08/21 | Not Applicable | Completed | |||
2023/02/03 | Phase 3 | Not yet recruiting | Guangxi Medical University | ||
2022/11/30 | Phase 4 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Akorn | 17478-546 | INTRAVENOUS | 1 mg in 1 mL | 5/23/2022 | |
| Mylan Institutional LLC | 67457-863 | INTRAVENOUS | 1 mg in 1 mL | 8/31/2017 | |
| WOCKHARDT LIMITED | 55648-661 | INTRAVENOUS | 1 mg in 1 mL | 11/29/2011 | |
| Fresenius Kabi USA, LLC | 63323-319 | INTRAVENOUS | 1 mg in 1 mL | 7/31/2022 | |
| Kyowa Kirin, Inc. | 42747-726 | TRANSDERMAL | 3.1 mg in 24 h | 12/15/2022 | |
| Breckenridge Pharmaceutical, Inc. | 51991-735 | ORAL | 1 mg in 1 1 | 2/29/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9745 | INTRAVENOUS | 1 mg in 1 mL | 1/4/2024 | |
| Fresenius Kabi USA, LLC | 63323-318 | INTRAVENOUS | 1 mg in 1 mL | 7/31/2022 | |
| Natco Pharma Limited | 63850-0005 | ORAL | 1 mg in 1 1 | 10/25/2019 | |
| Wockhardt USA LLC. | 64679-662 | INTRAVENOUS | 0.1 mg in 1 mL | 11/28/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/20/2012 | ||
Authorised | 4/20/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GRANISETRON-AFT SOLUTION FOR INJECTION 1MG/ML | SIN14612P | INJECTION, SOLUTION | 1 mg/ml | 9/11/2014 | |
| KYTRIL FOR INFUSION 1MG/ML | SIN13539P | INJECTION | 1 mg/ml | 8/26/2008 | |
| GRANISETRON FRESENIUS INJECTION 1MG/ML | SIN16141P | INJECTION, SOLUTION | 1MG/ML | 3/29/2021 | |
| KYTRIL TABLET 1 mg | SIN07800P | TABLET, FILM COATED | 1 mg | 7/21/1994 | |
| GRANODEX SOLUTION FOR INJECTION 1MG/ML | SIN16589P | INJECTION, SOLUTION | 1mg/ml | 9/1/2022 | |
| KYTRIL FOR INFUSION 3 mg/3ml | SIN07089P | INJECTION | 3 mg/3 ml | 6/22/1992 | |
| EMENAT TABLETS 1 MG | SIN15174P | TABLET | 1.0 mg | 2/9/2017 | |
| Granisetron Kabi concentrate for solution for infusion 1mg/ml | SIN14409P | INFUSION, SOLUTION CONCENTRATE | 1mg/ml | 9/23/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Granisetron Hydrochloride Dispersible Tablets | 国药准字H20020303 | 化学药品 | 片剂 | 8/5/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20020421 | 化学药品 | 注射剂 | 3/5/2024 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20041064 | 化学药品 | 注射剂 | 9/28/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20041196 | 化学药品 | 注射剂 | 5/17/2019 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20010602 | 化学药品 | 注射剂 | 9/7/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20040068 | 化学药品 | 注射剂 | 6/15/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20030823 | 化学药品 | 注射剂 | 4/24/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20030399 | 化学药品 | 注射剂 | 11/25/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20030466 | 化学药品 | 注射剂 | 6/22/2020 | |
| Granisetron Hydrochloride and Sodium Chloride Injection | 国药准字H20020366 | 化学药品 | 注射剂 | 8/14/2020 |
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 |
|---|---|---|---|---|---|
| KYTRIL granisetron (as hydrochloride) 3mg/ 3mL injection ampoule | 97550 | Medicine | A | 12/2/2003 | |
| KYTRIL granisetron (as hydrochloride) 2mg tablet blister pack | 60872 | Medicine | A | 8/5/1997 | |
| GRANISETRON KABI granisetron (as hydrochloride) 1mg/1mL concentrated injection ampoule | 159273 | Medicine | A | 8/12/2010 | |
| APO-GRANISETRON granisetron hydrochloride 1mg/1mL injection ampoule | 217091 | Medicine | A | 12/17/2014 | |
| Granisetron-AFT, granisetron (as hydrochloride) 1 mg/mL, concentrated injection, clear type I glass ampoule | 300321 | Medicine | A | 5/31/2018 | |
| Granisetron-AFT, granisetron (as hydrochloride) 3 mg/3 mL, concentrated injection, clear type I glass ampoule | 300322 | Medicine | A | 5/31/2018 | |
| APO-GRANISETRON granisetron hydrochloride 3mg/3mL injection ampoule | 217090 | Medicine | A | 12/17/2014 | |
| KYTRIL granisetron (as hydrochloride) 1mg/1mL injection | 115317 | Medicine | A | 2/9/2005 | |
| GRANISETRON KABI granisetron (as hydrochloride) 3mg/3mL concentrated injection ampoule | 159274 | Medicine | A | 8/12/2010 |