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Tirzepatide and Semaglutide: Helpful in managing obesity

(Preliminary Exam: General Science)
(Main Exam, General Studies Paper- 3: Science and Technology- developments and applications and its impact on everyday life)

Reference

An expert committee of India's drug regulatory body, Central Drugs Standard Control Organisation (CDSCO), has given the green signal to a drug containing 'Active Pharmaceutical Ingredients' (API) called Tirzepatide.

key points

  • The name of this drug is 'Zepbound'. Based on the recommendation of this committee, it is expected to get final approval from the 'Drug Controller General' of India.
  • After this, the American company Eli Lilly, the manufacturer of Zepbound, will get permission to launch its drug in the Indian market.

Active Pharmaceutical Ingredient (API)

  • Every medicine is made up of two main components. One of these components is the chemically active API. It is a component (substance) that is responsible for the treatment of a disease. API can be considered the main or central component.
  • The second component is the chemically inactive component (Excipients). It is a substance that transmits the effect of API to some part or system of the body. The formula of a medicine is prepared by mixing these two components.
  • API is a chemical compound that is the most important raw material for the final production of a medicine. It is the API that produces the necessary effect for the treatment of a disease.
    • For example, paracetamol is an API for Crocin and it is this paracetamol API that provides relief from body pain and fever, while mg represents the amount of active pharmaceutical ingredient (API) present in a medicine. Crocin 450 mg means that this tablet contains 450 mg of active pharmaceutical ingredient.
  • Fixed-dose combination drugs use multiple APIs, while single-dose drugs like Crocin use just one API.
  • An API is not made from a raw material in a single reaction, but rather through a series of chemical reactions. Chemical compounds that are in the process of forming an API from a raw material are called intermediates.

Background of weight loss drug development

  • Danish pharma company Novo Nordisk developed the drug Ozempic for the management of type 2 diabetes. It used semaglutide as the active pharmaceutical ingredient (API).
  • However, the drug had a side effect in the form of weight loss. After this, American doctors started off-label prescription of Ozempic for the treatment of obesity.
    • The practice of prescribing a medication for a purpose other than the approved purpose is called off-label prescription.
  • Thus, a new anti-obesity drug called Wegovy was developed using semaglutide in slightly higher doses.
  • Pharma company Eli Lilly also launched a type 2 diabetes drug called Mounjaro using tirzepatide as its API. However, this too has found widespread off-label use as it helps in weight loss.
    • Subsequently, the drug 'Zepbound' using tirzepatide was approved for the treatment of obesity.

About Semaglutide and Tirzepatide

  • The FDA has approved Wegovy (semaglutide) and Zepabound (tirzepatide) for long-term weight management in adults.
  • These drugs can be given to people who are obese (body mass index greater than 30) or overweight (BMI 27 to 30) with at least one other related health problem (such as high blood pressure, high cholesterol or type 2 diabetes).
  • Both drugs are given as injections. Semaglutide and tirzepatide are polypeptides, or tiny proteins, that increase levels of naturally occurring hormones in the body. These hormones include glucagon-like-peptide 1 (GLP-1), which regulates weight through the brain and digestive system.
  • Increased secretion of GLP-1 stimulates neurons to produce a response that changes gut function, leading to a feeling of fullness. This also gives a feeling of ‘satisfaction’ (adequacy of food) in the brain.
    • These medicines also help manage glucose levels, which is an effective treatment for diabetes.
  • Semaglutide targets only GLP-1 receptors while tirzepatide also increases the ‘glucose-dependent insulinotropic polypeptide (GIP)’ hormone.
    • GIP also regulates weight through receptors in the brain and fat cells.
    • GIP hormone is secreted from the small intestine which increases the secretion of insulin after food intake. It is a member of the hormone family called incretin, the other main member of which is GLP-1 hormone.
  • Both these drugs cause weight loss as well as improvement in all cardiometabolic measures.

Some side effects of the drug

  • The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, fatigue, belching, hair loss, heartburn, allergic reactions, and injection-site problems.
  • There is also a potential risk of thyroid tumors, including thyroid cancer. Zepbound should not be used if you or someone in your family has ever had medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
    • MTC is a type of thyroid cancer, while MEN 2 is a rare inherited disorder affecting the endocrine glands.

Central Drugs Standard Control Organisation (CDSCO)

  • It is the Central Drugs Authority performing the functions assigned to the Central Government under the Drugs and Cosmetics Act.
  • It is headquartered in New Delhi and has six regional offices under its control. Its main functions are as follows:
    • Regulatory control on import of drugs
    • Approval of new drugs and clinical trials
    • Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB)
    • Grant of certain licences as Central License Approval Authority, etc.
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