Eli Lilly Launches Innovative Dual GIP/GLP-1 Receptor Agonist Mounjaro for Type 2 Diabetes

　　【Pharmaceutical Network Product InformationRecently, the FDA has approved Eli Lilly's glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist tirzepatide (brand name: Mounjaro) for marketing. This new diabetes drug is administered once a week to assist with diet and exercise in improving blood sugar control in adults with type 2 diabetes.
 

Diabetes is a metabolic disease characterized clinically by hyperglycemia, and its causes and pathogenesis are not yet fully understood. Type 2 diabetes, a particularly common form of diabetes, is a chronic and progressive disease in which the body cannot properly produce or use insulin, leading to elevated levels of glucose (sugar) in the blood.
 

Currently, there are various drugs for treating diabetes, representing a vast market scale. According to a Frost & Sullivan report, the total global market size for type 2 diabetes alone has approached nearly 70 billion US dollars.
 

In the United States, according to data from the FDA, more than 30 million Americans suffer from type 2 diabetes, but many patients still have unmet treatment needs.
 

Mounjaro is a "first-in-class" drug that improves blood sugar control by simultaneously activating GIP and GLP-1 receptors. The medication is administered once weekly via subcutaneous injection, with the dosage adjusted based on patient tolerance to achieve blood sugar control targets. GIP is a hormone that complements the action of GLP-1 receptor agonists. Preclinical models have demonstrated that GIP reduces food intake and increases energy expenditure, leading to weight loss. Moreover, when GIP is used in combination with GLP-1 receptor agonists, it may have a greater impact on patients' blood sugar levels and body weight.
 

It is reported that this approval was based on the positive results of the Phase III SURPASS program, which consisted of 10 clinical trials and planned to enroll more than 13,000 patients with type 2 diabetes, including five global registration studies. These included active comparator studies with semaglutide 1 mg, insulin glargine, and degludec insulin. These studies evaluated the efficacy of Mounjaro (5mg, 10mg, and 15mg) when used alone or in combination with commonly prescribed diabetes medications (including metformin, SGLT2 inhibitors, sulfonylureas, and insulin glargine).
 

In the SURPASS project, Mounjaro at a 5mg dose reduced A1C levels by an average of 1.8%-2.1% in participants, while the 10mg and 15mg doses decreased A1C levels by an average of 1.7%-2.4%.
 

FDA pointed out that Mounjaro, when used in conjunction with controlled diet and exercise, can improve blood glucose levels and is more effective than other diabetes therapies compared to it in clinical studies.
 

Notably, in addition to helping patients with type 2 diabetes control their blood sugar, Eli Lilly also stated that a late-stage trial of Mounjaro showed that, while achieving blood sugar control goals, it can also help obese patients lose weight and reduce the average weight of participants by more than 20% for the first time.
 

Eli Lilly stated that obesity increases the risk of diabetes and various metabolic diseases; therefore, by treating obesity, the occurrence of metabolic diseases and related complications can be reduced, thereby improving people's health. To this end, Eli Lilly will discuss with the FDA and seek regulatory approval for this indication.
 

According to research firm Refinitiv's survey data, analysts currently project that Mounjaro's sales will reach $4.7 billion by 2026. Similar diabetes drugs include Novo Nordisk's semaglutide injection, which has already been approved by the FDA and is expected to generate over $3.7 billion in sales by 2025. In the Chinese market, the semaglutide injection (brand name: Ozempic) generated nearly 300 million yuan in sales in its first year on the market. This demonstrates the significant market space and potential for diabetes drugs.