Delving into the Latest Updates on Adamgammadex Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amogammadex Sodium

+ [2]

Target-

Mechanism

Muscle relaxation antagonists

Therapeutic Areas

Other Diseases

Active Indication

Reversal of Neuromuscular Blockade

Inactive Indication-

Originator Organization

Hangzhou Adamerck Pharmlabs, Inc.

Active Organization

Hangzhou Adamerck Pharmlabs, Inc.

Zhejiang Xianju Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure

Molecular FormulaC88H136N8NaO56S8

InChIKeyQVDWPQDOFSYORM-JJVAFMKDSA-N

CAS Registry1309580-41-3

To evaluate the pharmacokinetic characteristics of omexin sodium after a single intravenous administration in subjects with different degrees of renal insufficiency and healthy subjects with normal renal function, assess the effects of different degrees of renal insufficiency on drug pharmacokinetics, and provide a basis for clinical medication in patients with renal insufficiency.

Start Date30 Jan 2024

Sponsor / Collaborator

Hangzhou Adamerck Pharmlabs, Inc.

[+1]

NCT05555758 / RecruitingPhase 1

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics Profile of Aom0319 in Healthy White Subjects

Only SAD study will be conducted in this project. SAD represents single ascending dose. Multiple ascending dose have been cancelled. This decision has been made at the discretion of the Sponsor.

Start Date15 Dec 2022

Sponsor / Collaborator

Amckaus PTY LTD.

CTR20213282 / CompletedPhase 3

一项拟行全麻下择期手术 ASA 1～3 级患者给予罗库溴铵后 PTC=1～2 时接受注射用奥美克松钠逆转神经肌肉阻滞作用的前瞻性、多中心、随机、盲法、阳性药平行对照的 III 期临床研究

[Translation] A prospective, multicenter, randomized, blinded, positive drug parallel controlled phase III clinical study on the effect of omexin sodium injection on reversal of neuromuscular blockade in ASA 1-3 patients undergoing elective surgery under general anesthesia after receiving rocuronium bromide at PTC = 1-2

主要研究目的：比较给予罗库溴铵后深度神经肌肉阻滞自然恢复到 PTC 1~2 时注射用奥美克松钠与舒更葡糖钠注射液（布瑞亭®）逆转罗库溴铵诱导的神经肌肉阻滞的有效性。次要研究目的： 1.比较全麻下择期手术受试者在罗库溴铵诱导的深度神经肌肉阻滞自然恢复到 PTC 1~2时给予 8 mg/kg 注射用奥美克松钠或 4 mg/kg 舒更葡糖钠后 5 min 内成功拮抗神经肌肉阻滞使 TOFr 恢复到≥0.9 的拮抗成功率。 2.比较注射用奥美克松钠与舒更葡糖钠注射液给药后 30 min 内的再箭毒化发生率。 3.评价注射用奥美克松钠逆转罗库溴铵诱导的深度神经肌肉阻滞的安全性。

[Translation]

Primary study objectives: To compare the effectiveness of omepromazine sodium injection and sugammadex sodium injection (Buretin®) in reversing rocuronium-induced neuromuscular blockade when deep neuromuscular blockade recovers naturally to PTC 1-2 after rocuronium administration. Secondary study objectives: 1. To compare the success rate of antagonism within 5 minutes after 8 mg/kg omepromazine sodium injection or 4 mg/kg sugammadex sodium injection in subjects undergoing elective surgery under general anesthesia when deep neuromuscular blockade induced by rocuronium recovers naturally to PTC 1-2. 2. To compare the incidence of recurarization within 30 minutes after administration of omepromazine sodium injection and sugammadex sodium injection. 3. To evaluate the safety of omepromazine sodium injection in reversing rocuronium-induced deep neuromuscular blockade.

Start Date19 Jun 2022

Sponsor / Collaborator

Hangzhou Adamerck Pharmlabs, Inc.

[+1]

100 Clinical Results associated with Adamgammadex Sodium

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100 Translational Medicine associated with Adamgammadex Sodium

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100 Patents (Medical) associated with Adamgammadex Sodium

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17

Literatures (Medical) associated with Adamgammadex Sodium

01 Apr 2024·British Journal of Anaesthesia

Phase III clinical trial comparing the efficacy and safety of adamgammadex with sugammadex for reversal of rocuronium-induced neuromuscular block. Comment on Br J Anaesth 2024; 132: 45–52

Letter

Author: Sunaga, Hiroshi ; Miyazaki, Yusuke ; Suzuki, Kaoru

01 Jan 2024·Clinical and Translational Science

Efficacy and safety of adamgammadex for reversing rocuronium‐induced deep neuromuscular blockade: A multicenter, randomized, phase IIb study

Article

Author: Jie, Qing ; Chen, Sifan ; Zhao, Yanhua ; Qi, Youmao ; Yu, Weifeng ; Ji, Fuhai ; Zhang, Xiaoqing ; Wang, Dongxin ; Chen, Guozhong ; Su, Diansan ; Xie, Wenqin

AbstractThe rapid reversal of deep neuromuscular blockade (NMB) is important but remains challenging. This study aimed to evaluate the efficacy and safety of adamgammadex versus sugammadex in reversing deep rocuronium‐induced NMB. This multicenter, randomized, phase IIb study included 80 patients aged 18–64 years, American Society of Anesthesiologists (ASA) grade 1–2, undergoing elective surgery under general anesthesia with rocuronium. Patients were randomized to the adamgammadex 7, 8, and 9 mg/kg group or the sugammadex 4 mg/kg group. The primary efficacy variable was the time to recovery of train‐of‐four ratio (TOFr) to 0.9. The secondary efficacy variables were the time to recovery of TOFr to 0.7, antagonistic success rate of the recovery of TOFr to 0.9 within 5 min, and incidence rate of recurarization within 30 min after drug administration. The explorative efficacy variable was the time to recovery of the corrected TOFr to 0.9 (actual/baseline TOF ratio). Adamgammadex 7, 8, and 9 mg/kg and sugammadex 4 mg/kg groups did not significantly differ in all efficacy variables. Importantly, adamgammadex 9 mg/kg permitted reversal within a geometric mean of 2.9 min. According to the safety profile, adamgammadex achieved good tolerance and low incidence of drug‐related adverse events compared with the 4 mg/kg sugammadex. Adamgammadex 7, 8, and 9 mg/kg facilitated rapid reversal of deep rocuronium‐induced NMB and had good tolerance and low incidence of drug‐related adverse events. Therefore, adamgammadex is a potential and promising alternative to sugammadex.

01 Jan 2024·British Journal of Anaesthesia

Is adamgammadex the brother of sugammadex or the next generation of reversal agent?

Author: Hunter, Jennifer M ; Sneyd, J Robert

Sugammadex is now in widespread use to reverse the neuromuscular blocking effects of rocuronium. Adverse effects from sugammadex are rare, but anaphylactic and cardiovascular reactions to the drug have been reported. In an attempt to reduce such side-effects, a modified gamma-cyclodextrin, adamgammadex, has been developed. Phase 3 clinical trials suggest that it is slightly less potent than sugammadex and has a non-inferior speed of onset. In a multicentre trial of 310 patients, there was a suggestion of a lower incidence of allergic responses and recurarisation after adamgammadex compared with sugammadex. The clinical implications of this study are discussed in this editorial.

100 Deals associated with Adamgammadex Sodium

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Reversal of Neuromuscular Blockade	NDA/BLA	CN	Hangzhou Adamerck Pharmlabs, Inc.	18 Sep 2024
Reversal of Neuromuscular Blockade	NDA/BLA	CN	Zhejiang Xianju Pharmaceutical Co., Ltd.	18 Sep 2024