Delving into the Latest Updates on Adamgammadex Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amogammadex Sodium, AOM0498-16, Aom-0319

+ [2]

Target-

Action

antagonists

Mechanism

Muscle relaxation antagonists

Therapeutic Areas

Nervous System DiseasesOther DiseasesCardiovascular Diseases

Active Indication

Reversal of Neuromuscular Blockadestroke; sequelae

Inactive Indication-

Originator Organization

Hangzhou Adamerck Pharmlabs, Inc.

Active Organization

Hangzhou Adamerck Pharmlabs, Inc.

Zhejiang Xianju Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization

Hangzhou Adamerck Pharmlabs, Inc.

Zhejiang Xianju Pharmaceutical Co., Ltd.

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

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

/ CompletedPhase 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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19

Literatures (Medical) associated with Adamgammadex Sodium

01 Jun 2025·BRITISH JOURNAL OF ANAESTHESIA

Developing novel drugs to reverse neuromuscular block: do we need them?

Review

Author: Hunter, Jennifer M ; Blobner, Manfred

In the last 5 yr, rocuronium followed by reversal with sugammadex has become the most common combination of neuromuscular blocking drug and neuromuscular block antagonist in use during anaesthesia in the developed world. Despite a low incidence of side-effects from this drug combination, research continues on the development of new reversal agents. This includes development of new gamma cyclodextrins such as adamgammadex, and unrelated compounds such as calabadion 2 and Pillar[6]MaxQ, that not only sequestrate rocuronium, but also opioids such as fentanyl. The reasons for such work are questioned with the acknowledgement that, as in all areas of anaesthetic practice, the search for perfect drugs continues despite the limited clinical demand.

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·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	China	Hangzhou Adamerck Pharmlabs, Inc.	18 Sep 2024
Reversal of Neuromuscular Blockade	NDA/BLA	China	Zhejiang Xianju Pharmaceutical Co., Ltd.	18 Sep 2024
stroke; sequelae	Preclinical	China	Hangzhou Adamerck Pharmlabs, Inc.	01 May 2025