Remogliflozin Etabonate: First Global Approval
- 40 Downloads
Remogliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor, which is to be administered as remogliflozin etabonate (Remo™, Remozen™), the prodrug for remogliflozin, recently received its first approval as a treatment for type 2 diabetes mellitus (T2DM) in India. This article summarizes the milestones in the development of remogliflozin etabonate leading to this first approval for T2DM.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
- 1.Kapur A, O’Connor-Semmes R, Hussey EK, et al. First human dose-escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus. BMC Pharmacol Toxicol. 2013;14(26):1–11.Google Scholar
- 2.Glenmark Pharmaceuticals. Glenmark launches novel, globally-researched anti-diabetes drug remogliflozin in India [media release]. 30 Apr 2019. https://www.prnewswire.com/in/news-releases/glenmark-launches-novel-globally-researched-anti-diabetes-drug-remogliflozin-in-india-806614073.html.
- 3.Wilkison B, Cheatham B, Walker S. Remogliflozin etabonate reduces FIB-4 and NAFLD fibrosis scores in type 2 diabetic subjects [abstract no. 1087]. Hepatology. 2016;64(1 Suppl.):548A.Google Scholar
- 4.Glenmark Pharmaceuticals. Remogliflozin etabonate 100 mg tablets: proposed summary of product characteristics. 2019.Google Scholar
- 6.BHV Pharma. BHV Pharmaceuticals and Kissei Pharmaceutical Co. Ltd. sign exclusive worldwide license agreement for late-stage development product remogliflozin etabonate [media release]. 7 Jan 2011. http://www.bhvpharma.com.
- 7.Islet Sciences. Islet Sciences, Inc. announces exclusive licensing agreement between BHV Pharma and Libbs Farmaceutica to develop and commercialize SGLT2 inhibitor remogliflozin etabonate [media release]. 6 Oct 2014. http://www.isletsciences.com.
- 10.Girish G, Ulhas D, Vinu C, et al. Single dose pharmacokinetics of remogliflozin etabonate, a novel SGLT2 inhibitor, in healthy subjects [abstract]. J Assoc Physicians India. 2019;67(Feb).Google Scholar
- 12.Hussey EK, Kapur A, O’Connor-Semmes R, et al. Safety, pharmacokinetics and pharmacodynamics of remogliflozin etabonate, a novel SGLT2 inhibitor, and metformin when co-administered in subjects with type 2 diabetes mellitus. BMC Pharmacol Toxicol. 2013;14(25):1–11.Google Scholar
- 13.IND Committee. Minutes of IND committee meeting held on 15.03.2019 at ICMR (HQ). Agenda no. 3: application for marketing authorization of remogliflozin of M/s Glenmark Pharmaceuticals. 2019. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/IND15mar19.pdf. Accessed 3 May 2019.
- 14.Data on file, Glenmark Pharmaceuticals. 2019.Google Scholar
- 15.Avolynt. Avolynt, Inc. announces positive topline data for phase 2b BRID study of SGLT2 remogliflozin [media release]. 19 Dec 2016. http://www.avolynt.com.