Comprehensive Report on HRS-7535: An Investigational Oral Small Molecule GLP-1 Receptor Agonist

I. Introduction

HRS-7535 is an investigational oral small molecule therapeutic agent currently under development. It functions as a glucagon-like peptide-1 receptor (GLP-1R) agonist, a class of drugs that has demonstrated significant efficacy in the management of metabolic disorders.[1] The primary therapeutic areas targeted for HRS-7535 include type 2 diabetes mellitus (T2DM), for which it is in Phase 3 clinical trials, and obesity, with Phase 2 trials planned.[1] There is also an indication of potential development for diabetic nephropathy.[1] The development of an orally administered GLP-1R agonist like HRS-7535 is of considerable interest, as it offers a potential alternative to the predominantly injectable formulations currently available in this therapeutic class, which could enhance patient convenience and adherence. This report aims to provide a comprehensive overview of HRS-7535, encompassing its drug profile, mechanism of action, pharmacokinetic properties, clinical development program, safety and tolerability, efficacy findings, and future outlook.

II. Drug Profile of HRS-7535

A. Basic Information

HRS-7535 is identified as a small molecule drug.[1] It is also known by the synonyms KAI 7535 and KAI-7535.[1] The originator organization for HRS-7535 is Shandong Suncadia Medicine Co., Ltd..[1] Jiangsu Hengrui Medicine Co., Ltd. is listed as a developer alongside Shandong Suncadia Medicine.[2] Kailera Therapeutics, Inc. is also mentioned as an active organization involved with HRS-7535.[1] The relationship between these entities suggests a collaborative development effort, potentially with Shandong Suncadia leading early discovery and Jiangsu Hengrui, a major pharmaceutical entity [3], spearheading broader development and clinical trials, possibly with Kailera Therapeutics involved in specific aspects or regions.