In December 2020, Toralgen Inc announced that it was successfully accepted into the FDA’s Emerging Technology Program, based on the company’s development of a proprietary bile acid platform that has the potential to considerably improve drug delivery. This novel drug delivery system enables the oral delivery of large molecules, a particularly significant prospect for the likes of insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA) administration, which is often subcutaneous and therefore has poor patient compliance. The oral delivery of these therapies for type 2 diabetes (T2D) patients will prove highly popular and gain rapid uptake among both patients and physicians, as has been similarly seen with the launch of Novo Nordisk’s GLP-1RA Rybelsus (oral semaglutide).

Toralgen’s technology provides a significant promise to the oral delivery of major diabetic therapies following years of promising oral candidates failing to reach the market. Specifically, the Toralgen technology is a polybile nanodelivery system that consists of nanoparticles made up of bile acid polymerised ursodeoxycholic acid (PUDCA), with the FDA already having approved Ursodiol, soluble bile acid, previously. The advantage of the technology is the ability to protect the breakdown of large molecules in the intestine, significantly improving the bioavailability of large molecule drugs delivered. The development of technologies that enable the oral administration of insulin and GLP-1 is increasing throughout the T2D pipeline, with several promising agents in Phase II / III. Key opinion leaders (KOLs) interviewed by GlobalData have expressed their anticipation for orally delivered insulin and GLP-1 therapies to improve patient compliance and therefore improve long-term outcomes for T2D patients.

The FDA Emerging Technology program has been developed to recognise and promote the adoption of innovative approaches to pharmaceutical product design, and Toralgen has successfully met the criteria with its nanoparticle delivery system. The technology provides significant potential for oral drug delivery in the T2D space and is likely to gain a large market share provided that the technology proves to have greater efficacy and safety compared to leading oral T2D therapies currently in the pipeline. The likely leading oral insulin candidate is Biocon’s insulin tregopil, with an anticipated launch of late 2021 / 2022 in the Indian T2D market, followed by Oramed’s ORMD-0801, currently in Phase II, and likely to have a successful US market launch in 2024 / 2025. With the increasing likelihood of oral insulin entering the market over the next decade, Toralgen’s technology is promising news to a space requiring innovation, with many subcutaneously administered insulins entering an increasingly crowded market that offers only slight variation between products.

GlobalData predicts that the FDA’s acceptance of Toralgen’s nanoparticle delivery technology into its Emerging Technology Program increases the likelihood of its successful development and will potentially lead to Toralgen becoming a significant player in the insulin and GLP-1RA oral delivery market, particularly capturing market share from less innovative insulin and GLP-1 market incumbents.

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