The Subject Expert Committee under India’s apex drug regulator, Central Drugs Standard Control Organisation (CDSCO), has given the green signal to pharmaceutical giant Eli Lilly’s tirzepatide, an active ingredient in its blockbuster drugs Monjaro and Zepbound.

Last year, Zepbound, an injectable drug that fights obesity in adults, was approved by the US Food and Drug Administration (FDA).

All about tirzepatide

Tirzepatide is a drug developed by Eli Lilly and Company, which is mainly used to treat type 2 diabetes.

This compound is sold under the brand names Monjaro for diabetes and Zepbound for weight loss. However, in India, tirzepatide will be imported and marketed for diabetes, not weight loss. The obesity indication is under review.

It is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, meaning it mimics the effects of these naturally occurring hormones to help regulate blood sugar levels.

How does this work?

Tirzepatide stimulates the secretion of insulin from the pancreas in response to a meal. This helps to lower blood sugar levels after eating. It reduces the secretion of glucagon, which is a hormone that raises blood sugar levels.

Low levels of glucagon help reduce glucose production by the liver.

It slows down the emptying of the stomach, thereby reducing the rate at which glucose enters the bloodstream after a meal, thus helping in controlling the rise in blood sugar levels after a meal.

By acting on the appetite centers of the brain, tirzepatide may help reduce appetite and food intake, which may contribute to weight loss.

Are there any side effects?

Although tirzepatide can be effective in managing type 2 diabetes, it can also cause side effects. Monjaro (tirzepatide for type 2 diabetes or diabetes mellitus) is not for people with type 1 diabetes.

Common side effects include nausea, diarrhea, loss of appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain.

Some serious side effects may include inflammation of the pancreas or pancreatitis, low blood sugar levels when used with any other medication, severe allergic reactions, serious stomach problems, vision changes, and gallbladder problems.

The company says that if any side effects are noticed, tell your healthcare provider immediately.

Precautions

The company listed some warnings before using Moanzaro (tirzepatide).

• Your healthcare provider should tell you how to use Monjaro before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it.
• If you take birth control pills by mouth, talk to your healthcare provider before using Monjaro. Birth control pills may not work as well while you’re using Monjaro.

Earlier this year, Eli Lilly CEO David Ricks told Reuters that the company hoped to launch Monjaro in India in early 2025 following regulatory review.