Overview
Coenzyme M (commonly known by its salt form, Mesna) is a synthetic sulfhydryl (thiol) compound and is used for prophylaxis of Ifosfamide and cyclophosphamide induced hemorrhagic cystitis.
Background
Coenzyme M (commonly known by its salt form, Mesna) is a synthetic sulfhydryl (thiol) compound and is used for prophylaxis of Ifosfamide and cyclophosphamide induced hemorrhagic cystitis.
Indication
Mesna is a uroprotective agent and is used prophylactically to reduce ifosfamide and cyclophosphamide induced hemorrhagic cystitis.
Associated Conditions
- Hemorrhagic cystitis caused by cyclophosphamide
- Hemorrhagic cystitis caused by ifosfamide
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/04 | Not Applicable | Not yet recruiting | |||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/02/26 | Phase 2 | Recruiting | |||
2025/02/19 | Phase 1 | Recruiting | |||
2025/01/16 | Phase 1 | Recruiting | |||
2024/11/07 | Phase 1 | Suspended | |||
2024/04/03 | Phase 2 | Recruiting | |||
2024/03/22 | Phase 1 | Recruiting | |||
2024/01/05 | Phase 1 | Withdrawn | James Isaacs, MD | ||
2023/11/07 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Gland Pharma Limited | 68083-161 | INTRAVENOUS | 100 mg in 1 mL | 10/7/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9260 | INTRAVENOUS | 100 mg in 1 mL | 5/3/2023 | |
| Sagent Pharmaceuticals | 25021-201 | INTRAVENOUS | 100 mg in 1 mL | 3/21/2019 | |
| Baxter Healthcare Corporation | 0338-1305 | INTRAVENOUS | 100 mg in 1 mL | 3/17/2014 | |
| Fresenius Kabi USA, LLC | 63323-733 | INTRAVENOUS | 100 mg in 1 mL | 4/22/2019 | |
| Baxter Healthcare Company | 67108-3565 | ORAL | 400 mg in 1 1 | 12/17/2018 | |
| Baxter Healthcare Corporation | 67108-3565 | ORAL | 400 mg in 1 1 | 12/17/2018 | |
| Baxter Healthcare Corporation | 0338-1307 | INTRAVENOUS | 100 mg in 1 mL | 7/24/2018 | |
| Baxter Healthcare Corporation | 10019-953 | INTRAVENOUS | 100 mg in 1 mL | 3/20/2015 | |
| Baxter Healthcare Company | 10019-951 | INTRAVENOUS | 100 mg in 1 mL | 7/18/2018 |
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 |
|---|---|---|---|---|---|
| UROMITEXAN TABLETS 400 mg | SIN10703P | TABLET, FILM COATED | 400 mg | 1/25/1999 | |
| UROMITEXAN INJECTION 400mg/4ml | SIN05694P | INJECTION | 100.0 mg/ml | 4/8/1991 | |
| UROMITEXAN TABLETS 600 mg | SIN10704P | TABLET, FILM COATED | 600 mg | 1/25/1999 | |
| MESNA STADA® CONCENTRATE SOLUTION FOR INJECTION 400MG/4ML | SIN14991P | INJECTION, SOLUTION, CONCENTRATE | 400 mg/4 ml | 4/25/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mesna Injection | 国药准字H10950290 | 化学药品 | 注射剂 | 8/31/2020 | |
| Mesna Injection | 国药准字HJ20160239 | 化学药品 | 注射剂 | 2/27/2021 | |
| Mesna Injection | 国药准字H20059142 | 化学药品 | 注射剂 | 4/28/2021 | |
| Mesna Injection | 国药准字H10950007 | 化学药品 | 注射剂 | 8/31/2020 | |
| Mesna Injection | 国药准字H20093180 | 化学药品 | 注射剂 | 9/26/2023 | |
| Mesna Injection | 国药准字H20067661 | 化学药品 | 注射剂 | 8/4/2021 | |
| Mesna Injection | 国药准字H20093181 | 化学药品 | 注射剂 | 9/26/2023 | |
| Mesna Injection | 国药准字H20067660 | 化学药品 | 注射剂 | 8/4/2021 |
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 |
|---|---|---|---|---|---|
| UROMITEXAN mesna 400mg tablet blister pack | 56481 | Medicine | A | 8/28/1996 | |
| MESNA-CLARIS mesna 1000 mg/10 mL solution for injection ampoule | 272797 | Medicine | A | 8/1/2017 | |
| MESNA-CLARIS mesna 200 mg/2 mL solution for injection ampoule | 272799 | Medicine | A | 8/1/2017 | |
| UROMITEXAN mesna 600mg tablet blister pack | 56482 | Medicine | A | 8/28/1996 | |
| MESNA-CLARIS mesna 400 mg/4 mL solution for injection ampoule | 272798 | Medicine | A | 8/1/2017 | |
| UROMITEXAN 1g/10mL injection ampoule | 46629 | Medicine | A | 10/21/1993 | |
| UROMITEXAN 400mg/4mL injection ampoule | 46627 | Medicine | A | 10/21/1993 |