Overview
Sugammadex is a selective relaxant binding agent indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide during surgery. Rocuronium bromide and vecuronium bromide are neuromuscular blocking medications that cause temporary paralysis and are especially useful for general anesthesia, ventilation, or tracheal intubation that patients may require for surgery. Sugammadex provides a new treatment option to reverse the effects of those medications and possibly help patients recover sooner post-surgery. Sugammadex (brand name Bridion) is marketed by Merck Sharp and Dohme, and was approved by the United States FDA on December 15, 2015.
Background
Sugammadex is a selective relaxant binding agent indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide during surgery. Rocuronium bromide and vecuronium bromide are neuromuscular blocking medications that cause temporary paralysis and are especially useful for general anesthesia, ventilation, or tracheal intubation that patients may require for surgery. Sugammadex provides a new treatment option to reverse the effects of those medications and possibly help patients recover sooner post-surgery. Sugammadex (brand name Bridion) is marketed by Merck Sharp and Dohme, and was approved by the United States FDA on December 15, 2015.
Indication
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients ≥2 years old who are undergoing surgery.
Associated Conditions
- Neuromuscular blockade caused by vecuronium bromide
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/21 | Phase 1 | Completed | |||
2025/01/27 | Phase 1 | Recruiting | |||
2024/11/07 | Not Applicable | Not yet recruiting | |||
2024/10/09 | Not Applicable | ENROLLING_BY_INVITATION | |||
2024/10/08 | N/A | Completed | |||
2024/08/28 | Phase 2 | Not yet recruiting | Sang-Hwan Ji | ||
2024/08/20 | N/A | Not yet recruiting | Jun Zhang | ||
2024/05/31 | Not Applicable | Completed | Beijing Tongren Hospital | ||
2024/05/03 | Not Applicable | Not yet recruiting | |||
2024/03/28 | Not Applicable | Recruiting | The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
ProPharma Distribution | 84549-423 | INTRAVENOUS | 100 mg in 1 mL | 6/9/2025 | |
Merck Sharp & Dohme LLC | 0006-5425 | INTRAVENOUS | 100 mg in 1 mL | 11/17/2022 | |
Merck Sharp & Dohme LLC | 0006-5423 | INTRAVENOUS | 100 mg in 1 mL | 11/17/2022 | |
Medical Purchasing Solutions, LLC | 71872-7187 | INTRAVENOUS | 100 mg in 1 mL | 5/10/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/23/2023 | ||
Authorised | 6/23/2023 | ||
Authorised | 6/23/2023 | ||
Extrovis EU Ltd.,Patriarka utca 14,2000 Szentendre,Hungary | Authorised | 5/26/2023 | |
Authorised | 7/15/2022 | ||
Authorised | 11/15/2021 | ||
Authorised | 11/15/2021 | ||
Authorised | 1/10/2023 | ||
Authorised | 1/10/2023 | ||
Authorised | 7/25/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SUGAMMADEX KABI SOLUTION FOR INJECTION 100 MG/ML | SIN16988P | INJECTION, SOLUTION | 100 mg/ml | 4/19/2024 | |
Bridion Solution For Injection 100mg/ml | SIN13812P | INJECTION, SOLUTION | 100mg | 5/31/2010 | |
SUGAMMADEX SANDOZ SOLUTION FOR INJECTION 100MG / ML | SIN16880P | INJECTION, SOLUTION | 100.0 mg/mL | 10/11/2023 | |
SUGAMMADEX-TEVA SOLUTION FOR INJECTION 100MG/ML | SIN16962P | INJECTION, SOLUTION | 100mg/ml | 2/26/2024 | |
SUGAMMADEX SCIGEN SOLUTION FOR INJECTION 100MG/ML | SIN16933P | INJECTION, SOLUTION | 100mg/ml | 1/23/2024 | |
ACCODEX SOLUTION FOR INJECTION 100MG/ML | SIN16994P | INJECTION, SOLUTION | 100 mg/ml | 4/29/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Sugammadex Sodium Injection | 国药准字H20233991 | 化学药品 | 注射剂 | 8/1/2023 | |
Sugammadex Sodium Injection | 国药准字H20258028 | 化学药品 | 注射剂 | 3/5/2025 | |
Sugammadex Sodium Injection | 国药准字H20244701 | 化学药品 | 注射剂 | 8/20/2024 | |
Sugammadex Sodium Injection | 国药准字H20233990 | 化学药品 | 注射剂 | 8/1/2023 | |
Sugammadex Sodium Injection | 国药准字H20234584 | 化学药品 | 注射剂 | 12/5/2023 | |
Sugammadex Sodium Injection | 国药准字H20234504 | 化学药品 | 注射剂 | 11/21/2023 | |
Sugammadex Sodium Injection | 国药准字H20234129 | 化学药品 | 注射剂 | 9/12/2023 | |
Sugammadex Sodium Injection | 国药准字H20234605 | 化学药品 | 注射剂 | 12/5/2023 | |
Sugammadex Sodium Injection | 国药准字H20243562 | 化学药品 | 注射剂 | 4/24/2024 | |
Sugammadex Sodium Injection | 国药准字H20234606 | 化学药品 | 注射剂 | 12/5/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |