MedPath

Sugammadex

Generic Name
Sugammadex
Brand Names
Bridion, Sugammadex Adroiq, Sugammadex Amomed, Sugammadex Fresenius Kabi, Sugammadex Mylan, Sugammadex Piramal
Drug Type
Small Molecule
Chemical Formula
C72H112O48S8
CAS Number
343306-71-8
Unique Ingredient Identifier
361LPM2T56

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

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.
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