NEW DELHI: US-based pharmaceutical giant Eli Lilly has launched its blockbuster diabetes and weight-loss drug, Mounjaro, in India following approval from the country's drug regulator.
The much-anticipated drug, available in a single-dose vial, received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO).
It is the first-of-its-kind treatment that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors, making it a breakthrough therapy for type 2 diabetes, obesity, and overweight management.
“The dual burden of obesity and type 2 diabetes is rapidly emerging as a major public health challenge in India. Lilly is committed to collaborating with the government and industry to promote awareness and improve the prevention and management of these diseases,” said Winselow Tucker, President and General Manager, Lilly India.
Mounjaro, chemically known as tirzepatide, is a once-weekly prescription injection and should be used under medical supervision. The drug is priced at ₹3,500 for the 2.5 mg vial and ₹4,375 for the 5 mg vial, with Lilly stating that this India-specific pricing reflects its commitment to expanding access to innovative treatments.
India is witnessing a sharp rise in obesity and diabetes cases, with approximately 101 million people living with diabetes. Nearly half of these adult patients are inadequately treated with suboptimal glycaemic control, according to the company. Obesity, a chronic relapsing disease, is a major risk factor for diabetes and is linked to over 200 health complications, including hypertension, dyslipidaemia, coronary heart disease, and obstructive sleep apnoea.
“As of 2023, adult obesity prevalence in India stood at around 6.5%, affecting nearly 100 million people,” the statement added.
A recent Lancet study estimated that by 2050, India will have 21.8 crore men and 23.1 crore women who are overweight or obese, totalling 44.9 crore people—nearly a third of the projected population.
“Obesity and diabetes are recognised as serious conditions linked to various life-limiting health complications, making effective and sustained treatment critical. We are thrilled to introduce Mounjaro in India to address these unmet medical needs,” said Dr Manish Mistry, Senior Medical Director, Lilly India. “Mounjaro may offer a new approach to metabolic health management, providing healthcare providers with an innovative option to treat these diseases.”
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity) or 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition. It is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Tirzepatide was evaluated in two major global clinical development programmes: the SURMOUNT-1 trials for chronic weight management and the SURPASS trials for type 2 diabetes.
In the SURMOUNT-1 study, involving 2,539 adults with obesity or excess weight and weight-related medical problems (excluding diabetes), participants taking Mounjaro alongside diet and exercise experienced significant weight loss compared to those on a placebo over 72 weeks.
At the highest dose (15 mg), people lost an average of 21.8 kg, while at the lowest dose (5 mg), they lost 15.4 kg (compared to 3.2 kg on placebo). Additionally, one in three patients taking the highest dose lost over 26.3 kg (25% of body weight), compared to just 1.5% in the placebo group.
In the phase 3 SURPASS programme, Mounjaro (5 mg, 10 mg, and 15 mg) was tested alone and in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas, and insulin glargine. Participants achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5 mg and between 1.7% and 2.4% for Mounjaro 10 mg and 15 mg over 40 weeks.
Mounjaro is a single molecule that selectively binds to and activates both GIP and GLP-1 receptors, which are natural incretin hormones. It improves first- and second-phase insulin secretion in a glucose-dependent manner, reduces glucagon levels, enhances insulin sensitivity, and delays gastric emptying. GIP and GLP-1 receptors are also expressed in key areas of the brain that regulate appetite.
The drug helps regulate lipid utilisation, reduce food intake, and lower body fat mass, leading to improved metabolic health outcomes.
Mounjaro is already available in the UK and Europe under the same brand name for both diabetes and weight-loss management. In the US, it is marketed as Zepbound for obesity.
“Mounjaro (tirzepatide) has already had a tremendous impact on millions of people living with type 2 diabetes and obesity,” the statement concluded.