Zepbound was approved as a drug for weight management by the US Food and Drug Administration (FDA) in 2023.
These receptors regulate gut function as well as the secretion of pancreatic hormones, and their malfunctioning triggers type 2 diabetes and obesity.
While tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, injectable semaglutide is a GLP-1 receptor agonist.
On average, semaglutide has been shown to reduce body weight by around 15 percent after 68 weeks.
In comparison, tirzepatide (Mounjaro) has been shown to reduce body weight by 22.5 percent after 72 weeks, on average.
In June this year, a subject expert committee (SEC) under the CDSCO recommended the regulatory approval for two formulations of tirzepatide – pre-filled pens and single-dose vials. The panel made this recommendation after reviewing data from the drug’s global clinical trials, which also included Indian participants.
Indianapolis-based pharmaceutical firm Eli Lilly and Company sells tirzepatide under the brand names Mounjaro and Zepbound. Mounjaro has been available in the US since 2022, and is indicated for diabetes. Zepbound was approved as a drug for weight management by the US Food and Drug Administration (FDA) in 2023.
New Delhi: A top panel under the Central Drugs Standard Control Organisation (CDSCO) — India’s national regulatory body for pharmaceuticals and medical devices — has recommended regulatory approval to import and market the type 2 diabetes and obesity drug tirzepatide in the country. But the drug is likely to be available in the country only next year, ThePrint has learnt.
These drugs should be administered as injections on a weekly basis.
“After detailed deliberation, the committee recommended for grant of permission for import and marketing of tirzepatide 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml and 15mg/0.5ml solution for injection in a single dose prefilled pen and in a single dose vial for chronic weight management subject to condition that firm should conduct phase-IV clinical trial,” the SEC (endocrinology and metabolism) said in its order.
ThePrint has seen a copy of the order. The CDSCO generally accepts SEC recommendations within days.
“The company now has the regulatory approval in place to launch the drug in India but we can do that in about six months from now after assessing the drug’s global supply chain status,” a source in Eli Lilly told ThePrint.
According to the FDA, there is a shortage in the supply of Mounjaro and Zepbound of several dosage strengths in the US, mainly due to huge demand for the medicines.
There have been similar reports from several other countries where the drug has been approved and used.
ThePrint has reached Eli Lilly and Company over email for a response on the development. This copy will be updated if and when a reply is received.
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How tirzepatide works, and its advantage over a similar drug
Semaglutide, sold by Danish drug maker Novo Nordisk, is another popular drug for type 2 diabetes and obesity.
It is marketed in the US under the brand names Wegovy and Ozempic.
Tirzepatide works by binding to the receptors of various gut hormones. These receptors regulate gut function as well as the secretion of pancreatic hormones, and their malfunctioning triggers type 2 diabetes and obesity.
While tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, injectable semaglutide is a GLP-1 receptor agonist.
A receptor agonist is a drug or substance that binds to a receptor inside a cell, and mimics the action of a neurotransmitter or hormone that normally binds to the receptor, according to the US National Cancer Institute.
GIP receptor agonists are medications that interact with hunger hormones, helping in weight management, and GLP-1 receptor agonists are drugs that reduce blood sugar and energy intake by activating the GLP-1 receptor, helping treat type 2 diabetes.
Incretins are gastrointestinal hormones that increase insulin release from beta cells when there is a glucose overload.
Eli Lilly had earlier said that Zepbound is the first and only obesity treatment of its kind that activates both GIP and GLP-1 hormone receptors.
This drug, like semaglutide, has the effect of creating a sense of fullness for longer, helping reduce appetite.
In June last year, detailed results from SURMOUNT-2, a phase 3 clinical trial evaluating the efficacy and safety of tirzepatide (10 mg and 15 mg) for chronic weight management in participants with obesity and type 2 diabetes, were published in the journal The Lancet. The findings showed that both doses of tirzepatide led to superior weight reduction compared to placebo.
The SURPASS-2 study, published in June 2021 in The New England Journal of Medicine, directly compared tirzepatide with semaglutide.
Speaking to ThePrint, Dr Rajeev Kovil, a Mumbai-based diabetes specialist and researcher, pointed out that in the SURPASS-2 study, tirzepatide 15 mg resulted in a faster and greater decline in body weight (5.5 kg) compared to semaglutide 1 mg. Tirzepatide more than doubled the proportion of patients achieving at least 10 percent weight loss.
On average, semaglutide has been shown to reduce body weight by around 15 percent after 68 weeks. In comparison, tirzepatide (Mounjaro) has been shown to reduce body weight by 22.5 percent after 72 weeks, on average.
However, these drugs also have side effects, mostly gastrointestinal reactions. In rare cases, these reactions can be severe. Another caveat is that once a patient discontinues such drugs, they regain body fat.
Experts believe that the high prices of these medicines could result in limited access to them. In the US, the starting cost of tirzepatide is $1043 or Rs 87,061 per shot. Eli Lilly is yet to reveal the drug’s cost in India.
(Edited by Radifah Kabir)
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