Survodutide
A differentiated glucagon/GLP-1 receptor dual agonist targeting obesity and MASH
Survodutide (formerly BI 456906), licensed to Boehringer Ingelheim, is an investigational long-acting, glucagon/GLP-1 receptor dual agonist for once-weekly subcutaneous administration. Through coordinated regulation of energy expenditure and energy intake, glucagon and GLP-1 receptor dual agonism may achieve superior body weight reductions relative to GLP-1 mono agonists, with equivalent glycemic control and direct, enhanced effects on the liver.
The molecule has been deliberately designed with strong bias towards the GLP-1 receptors, to leverage the body weight reduction and glycemic control of GLP-1 receptors while leveraging the direct effects of glucagon in the liver.
- PROGRAM Survodutide
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PARTNERS
- Phase 3
Development status
Boehringer Ingelheim is solely responsible for development and commercialization of survodutide globally.
Boehringer Ingelheim is evaluating survodutide in a global Phase 3 program for people living with obesity or overweight.
- SYNCHRONIZE-1 and SYNCHRONIZE-2, include people living with comorbidities, without and with type 2 diabetes, respectively.
- SYNCHRONIZE-MASLD trial includes adults with a confirmed or presumed diagnosis of MASH.
- SYNCHRONIZE-CVOT trial includes people living with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease.
In addition, Boehringer Ingelheim is exploring survodutide in regional Phase 3 clinical trials in Japan (SYNCHRONIZE-JP) and in China (SYNCHRONIZE-CN) for people living with obesity.
Boehringer Ingelheim is also evaluating the efficacy and safety of survodutide in two global Phase 3 trials for people living with metabolic dysfunction-associated steatohepatitis (MASH).
- LIVERAGE includes adults with MASH and fibrosis stages 2 or 3
- LIVERAGE-Cirrhosis includes adults with compensated MASH cirrhosis (stage 4)
Survodutide has been granted Fast Track Designation and Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3), as well as access to the Priority Medicine (PRIME) Scheme by the European Medicines Agency (EMA) for MASH with fibrosis. Survodutide has also been granted Breakthrough Therapy Designation by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) and Breakthrough Designation by the Taiwan Food and Drug Administration.
Survodutide is an investigational compound whose safety and efficacy have not been evaluated or approved for marketing by any regulatory authority.
Related scientific publications
All scientific publications-
Glucagon and GLP-1 receptor dual agonist survodutide improved liver histology in people with MASH and fibrosis: Results from a randomized, double-blind, placebo-controlled phase 2 trial
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The dual GCGR/GLP-1R agonist survodutide: Biomarkers and pharmacological profiling for clinical candidate selection
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Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial
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Dose–response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial
Learn about clinical trials involving survodutide
Licensed to Boehringer Ingelheim
Survodutide is licensed to Boehringer Ingelheim, with Boehringer solely responsible for development and commercialization globally. Zealand is eligible for up to EUR 315 million in outstanding potential development, regulatory and commercial milestones, as well as high single to low double digit percentage royalties on global sales.
Obesity
More about the disease area
Overweight and obesity are associated with more than 220 complications and comorbidities, including cardiovascular disease, liver disease, type 2 diabetes, kidney disease, and neuroinflammation.
