Overview
Parecoxib is a water-soluble and injectable prodrug of valdecoxib. It is marketed as Dynastat in the European Union. Parecoxib is a COX2 selective inhibitor in the same category as celecoxib (Celebrex) and rofecoxib (Vioxx). As it is injectable, it can be used perioperatively when patients are unable to take oral medications. It is approved through much of Europe for short term perioperative pain control much in the same way ketorolac (Toradol) is used in the United States. A letter of non-approval for parecoxib was issued by the FDA in 2005.
Background
Parecoxib is a water-soluble and injectable prodrug of valdecoxib. It is marketed as Dynastat in the European Union. Parecoxib is a COX2 selective inhibitor in the same category as celecoxib (Celebrex) and rofecoxib (Vioxx). As it is injectable, it can be used perioperatively when patients are unable to take oral medications. It is approved through much of Europe for short term perioperative pain control much in the same way ketorolac (Toradol) is used in the United States. A letter of non-approval for parecoxib was issued by the FDA in 2005.
Indication
Used for short term perioperative pain control.
Associated Conditions
- Postoperative pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/02 | Phase 2 | Not yet recruiting | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
2024/09/19 | Phase 4 | Not yet recruiting | |||
2025/02/18 | Phase 2 | Not yet recruiting | Fakultni Nemocnice U Sv Anny V Brne | ||
2024/03/18 | Phase 3 | Not yet recruiting | Oman Medical Speciality Board | ||
2024/03/12 | Not Applicable | Not yet recruiting | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | ||
2023/11/18 | Phase 4 | Completed | |||
2023/03/07 | Not Applicable | Recruiting | |||
2021/12/09 | Phase 4 | Completed | |||
2021/04/15 | Not Applicable | Completed | Saint Thomas Hospital, Panama | ||
2019/04/16 | Phase 2 | UNKNOWN | Buddhist Tzu Chi General Hospital |
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 |
|---|---|---|---|
Authorised | 3/22/2002 | ||
Authorised | 3/22/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Parecoxib WB Powder for Solution for Injection 40 mg/vial | Wanbang Biopharmaceuticals | SIN16913P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40mg/vial | 12/14/2023 |
| PARECOXIB SANDOZ POWDER FOR SOLUTION FOR INJECTION 40MG | SIN16721P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40mg/vial | 3/1/2023 | |
| PARECOXIB MYLAN POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL | Mylan Laboratories Ltd Hosur Steriles Facility (HSF) | SIN16666P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg/ vial | 1/5/2023 |
| Dynastat Powder and Solvent for Solution for Injection 40mg | SIN14149P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40mg | 5/14/2012 | |
| PARECOXIB-AFT POWDER FOR SOLUTION FOR INJECTION 40MG | SIN17012P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40mg | 5/17/2024 | |
| PARACOX POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL | SIN17079P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg/vial | 9/10/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Parecoxib Sodium for Injection | 国药准字H20213562 | 化学药品 | 注射剂 | 6/30/2021 | |
| Parecoxib Sodium for Injection | 国药准字H20213127 | 化学药品 | 注射剂 | 2/10/2021 | |
| Parecoxib Sodium for Injection | 国药准字H20213432 | 化学药品 | 注射剂 | 6/1/2021 | |
| Parecoxib Sodium for Injection | 国药准字H20234471 | 化学药品 | 注射剂 | 11/14/2023 | |
| Parecoxib Sodium for Injection | 国药准字H20203212 | 化学药品 | 注射剂 | 5/20/2020 | |
| Parecoxib Sodium for Injection | 国药准字H20213602 | 化学药品 | 注射剂 | 7/20/2021 | |
| Parecoxib Sodium for Injection | 国药准字H20213863 | 化学药品 | 注射剂 | 11/17/2021 | |
| Parecoxib Sodium for Injection | 国药准字H20223593 | 化学药品 | 注射剂 | 8/10/2022 | |
| Parecoxib Sodium for Injection | 国药准字H20213128 | 化学药品 | 注射剂 | 2/10/2021 | |
| Parecoxib Sodium for Injection | 国药准字H20203302 | 化学药品 | 注射剂 | 7/8/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||