Literature DB >> 32274703

Remimazolam: First Approval.

Susan J Keam1.   

Abstract

Remimazolam (Anerem® in Japan; ByFavo™ in the USA; Aptimyda™ in the EU) is an ultra-short-acting intravenous (IV) benzodiazepine sedative/anesthetic being developed by PAION AG in conjunction with a number of commercial partners for use in anesthesia and procedural sedation. Remimazolam was approved on 23 January 2020 in Japan for use in general anesthesia in adult patients. Remimazolam is also undergoing regulatory assessment in South Korea for this indication and for use in procedural sedation in the USA, the EU and China. This article summarises the major milestones in the development of remimazolam for this first approval for the induction and maintenance of general anaesthesia, and its potential upcoming approvals in general anaesthesia and procedural sedation.

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Year:  2020        PMID： 32274703     DOI： 10.1007/s40265-020-01299-8

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  16 in total

1.  A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part II. Population pharmacokinetic and pharmacodynamic modeling and simulation.

Authors:  Hugh R Wiltshire; Gavin J Kilpatrick; Gary S Tilbrook; Keith M Borkett
Journal:  Anesth Analg       Date:  2012-01-16       Impact factor: 5.108

2.  Safety, pharmacokinetic and pharmacodynamic properties of single ascending dose and continuous infusion of remimazolam besylate in healthy Chinese volunteers.

Authors:  Xiao-Yan Sheng; Yan Liang; Xue-Yuan Yang; Li-E Li; Xia Ye; Xia Zhao; Yi-Min Cui
Journal:  Eur J Clin Pharmacol       Date:  2019-12-23       Impact factor: 2.953

3.  Inhaled Remimazolam Potentiates Inhaled Remifentanil in Rodents.

Authors:  Tatjana Bevans; Cassandra Deering-Rice; Chris Stockmann; Joseph Rower; Derek Sakata; Christopher Reilly
Journal:  Anesth Analg       Date:  2017-05       Impact factor: 5.108

4.  A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy.

Authors:  Douglas K Rex; Raj Bhandari; Taddese Desta; Michael P DeMicco; Cynthia Schaeffer; Kyle Etzkorn; Charles F Barish; Ronald Pruitt; Brooks D Cash; Daniel Quirk; Felix Tiongco; Shelby Sullivan; David Bernstein
Journal:  Gastrointest Endosc       Date:  2018-04-30       Impact factor: 9.427

5.  A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy.

Authors:  Daniel J Pambianco; Keith M Borkett; Dennis S Riff; Peter J Winkle; Howard I Schwartz; Timothy I Melson; Karin Wilhelm-Ogunbiyi
Journal:  Gastrointest Endosc       Date:  2015-09-09       Impact factor: 9.427

6.  A phase Ib, dose-finding study of multiple doses of remimazolam (CNS 7056) in volunteers undergoing colonoscopy.

Authors:  Mark T Worthington; Laurie J Antonik; D Ronald Goldwater; James P Lees; Karin Wilhelm-Ogunbiyi; Keith M Borkett; Mack C Mitchell
Journal:  Anesth Analg       Date:  2013-11       Impact factor: 5.108

7.  Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics.

Authors:  Jürgen Schüttler; Andreas Eisenried; Marco Lerch; Jörg Fechner; Christian Jeleazcov; Harald Ihmsen
Journal:  Anesthesiology       Date:  2020-04       Impact factor: 7.892

8.  Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy.

Authors:  Nicholas J Pastis; Lonny B Yarmus; Frank Schippers; Randall Ostroff; Alexander Chen; Jason Akulian; Momen Wahidi; Samira Shojaee; Nichole T Tanner; Sean P Callahan; Gregory Feldman; Daniel G Lorch; Ikeadi Ndukwu; Michael A Pritchett; Gerard A Silvestri
Journal:  Chest       Date:  2018-10-04       Impact factor: 9.410

9.  Metabolism of remimazolam in primary human hepatocytes during continuous long-term infusion in a 3-D bioreactor system.

Authors:  Nora Freyer; Fanny Knöspel; Georg Damm; Selina Greuel; Christin Schneider; Daniel Seehofer; Thomas Stöhr; Karl-Uwe Petersen; Katrin Zeilinger
Journal:  Drug Des Devel Ther       Date:  2019-04-02       Impact factor: 4.162

10.  Time-to-Event Modeling for Remimazolam for the Indication of Induction and Maintenance of General Anesthesia.

Authors:  Lauren L Lohmer; Frank Schippers; Karl Uwe Petersen; Thomas Stoehr; Virginia D Schmith
Journal:  J Clin Pharmacol       Date:  2020-01-27       Impact factor: 3.126
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  17 in total

Review 1.  Structural Modification in Anesthetic Drug Development for Prodrugs and Soft Drugs.

Authors:  Chaoyi Deng; Jin Liu; Wensheng Zhang
Journal:  Front Pharmacol       Date:  2022-07-01       Impact factor: 5.988

2.  Remimazolam induced cognitive dysfunction in mice via glutamate excitotoxicity.

Authors:  Xin-Hua Zhou; Cheng-Cheng Zhang; Ling Wang; Shan-Liang Jin
Journal:  Transl Neurosci       Date:  2022-05-31       Impact factor: 1.264

3.  Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial.

Authors:  Xiaoqiang Zhang; Shuang Li; Jing Liu
Journal:  BMC Anesthesiol       Date:  2021-05-20       Impact factor: 2.217

4.  Effects of Remimazolam and Propofol on Ca2+ Regulation by Ryanodine Receptor 1 with Malignant Hyperthermia Mutation.

Authors:  Tomoyuki Watanabe; Hirotsugu Miyoshi; Yuko Noda; Soshi Narasaki; Atsushi Morio; Yukari Toyota; Hiroshi Kimura; Keiko Mukaida; Toshimichi Yasuda; Yasuo M Tsutsumi
Journal:  Biomed Res Int       Date:  2021-01-04       Impact factor: 3.411

5.  The effect of obstructive jaundice on the sensitivity of intravenous anesthetic of remimazolam: study protocol for a controlled multicenter trial.

Authors:  Wen Liu; Bin Yang; Jun-Wei Ji; Hua Yang; Hong-Hao Song; Hai-Bo Qiu; Jin-Chao Song
Journal:  Trials       Date:  2022-01-08       Impact factor: 2.279

6.  The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial.

Authors:  Xianwen Liu; Baofeng Ding; Fu Shi; Yang Zhang; Lei Liu; Yongwei Sha; Tonghang Zhao
Journal:  Drug Des Devel Ther       Date:  2021-11-16       Impact factor: 4.162

7.  Protective Effects of Remimazolam on Cerebral Ischemia/Reperfusion Injury in Rats by Inhibiting of NLRP3 Inflammasome-Dependent Pyroptosis.

Authors:  Min Shi; Jing Chen; Tianxiao Liu; Weixin Dai; Zhan Zhou; Lifei Chen; Yubo Xie
Journal:  Drug Des Devel Ther       Date:  2022-02-18       Impact factor: 4.162

8.  Effect of remimazolam induction on hemodynamics in patients undergoing valve replacement surgery: A randomized, double-blind, controlled trial.

Authors:  Tianxiao Liu; Ting Lai; Jing Chen; Yizhi Lu; Fang He; Yanhua Chen; Yubo Xie
Journal:  Pharmacol Res Perspect       Date:  2021-10

Review 9.  Efficacy of Remimazolam for Procedural Sedation in American Society of Anesthesiologists (ASA) I to IV Patients Undergoing Colonoscopy: A Systematic Review and Meta-Analysis.

Authors:  Ibtehaj Ul-Haque; Taha Gul Shaikh; Syed Hassan Ahmed; Summaiyya Waseem; Nashwa A Qadir; Taha Bin Arif; Shamim Ul Haque
Journal:  Cureus       Date:  2022-03-06

10.  Remimazolam for induction of anesthesia in elderly patients with severe aortic stenosis: a prospective, observational pilot study.

Authors:  Toshiyuki Nakanishi; Yoshiki Sento; Yuji Kamimura; Tatsuya Tsuji; Eisuke Kako; Kazuya Sobue
Journal:  BMC Anesthesiol       Date:  2021-12-06       Impact factor: 2.217
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