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Mazdutide

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Mazdutide

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Mazdutide
Generic Name (API): Mazdutide
Dosage Form & Strength: 2 mg / 4 mg / 6 mg
Route: Subcutaneous (SC) injection
Drug Class: Dual GLP-1 / glucagon receptor agonist

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Mazdutide Used For?

Mazdutide is a once-weekly injection for adults with type 2 diabetes, and it is also approved for long-term weight management. It was developed in China by Innovent Biologics, under a licence from Eli Lilly and Company, and is sold there as 信尔美®. It is the first medicine approved anywhere that acts on both the GLP-1 and the glucagon receptors.

China's National Medical Products Administration (NMPA) approved it in two steps:

  • June 2025 – weight management: alongside a reduced-calorie diet and more physical activity, for adults with a BMI of 28 kg/m² or more, or 24 kg/m² or more with at least one weight-related condition such as high blood sugar, high blood pressure, abnormal cholesterol or fatty liver
  • September 2025 – type 2 diabetes: to improve blood sugar control in adults, either on its own when diet and exercise are not enough, or added to metformin and/or a sulfonylurea, or metformin and/or an SGLT2 inhibitor

It is a prescription endocrine and metabolic medicine and should be started and monitored by an endocrinologist or diabetologist.

How It Works

After a meal, the gut releases a hormone called GLP-1 that tells the pancreas to release insulin, slows the stomach and reduces appetite. Mazdutide copies that signal and, at the same time, switches on the glucagon receptor, which is involved in how the body burns energy and handles fat in the liver. A fatty-acid chain attached to the peptide lets it stay in the body for about eight days (average half-life 196 hours), which is why one injection a week is enough.

What the Trials Showed

Two phase 3 trials in China, DREAMS-1 and DREAMS-2, included 1,050 adults with type 2 diabetes, 698 of whom received mazdutide. Average HbA1c at the start was about 8.2%.

  • DREAMS-1 (on its own, 319 people): after 24 weeks HbA1c fell by 1.58% on 4 mg and 2.02% on 6 mg, against 0.25% on placebo. 66.4% and 81.8% reached an HbA1c below 7%, compared with 11.7%. Body weight fell by 5.5% and 7.3% (placebo 1.2%).
  • DREAMS-2 (added to tablets, 731 people): after 28 weeks HbA1c fell by 1.61% and 1.66%, compared with 1.36% on an established once-weekly GLP-1 injection used as the comparison. Weight fell by 6.6% and 8.5%, against 2.8%.

In the separate GLORY-1 weight trial (610 adults with overweight or obesity), people lost an average of 11.0% (4 mg) and 14.0% (6 mg) of their body weight at 48 weeks, against a 0.3% gain on placebo.

Recommended Dosage

The Chinese label uses the same step-up plan for both uses:

  • Weeks 1–4: 2 mg once a week (a starting dose to help the stomach adjust, not a treatment dose)
  • Weeks 5–8: 4 mg once a week
  • Week 9 onwards: 4 mg or 6 mg once a week as the maintenance dose; the doctor can go back to 4 mg if 6 mg is not tolerated

It is injected under the skin of the abdomen, at any time of day, with or without food. It must never be given into a vein or muscle. If it is added to a sulfonylurea, the doctor may lower the sulfonylurea dose to reduce the risk of low blood sugar. Metformin can usually continue at the same dose.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Thyroid tumour warning: the Chinese label carries a boxed warning. In lifelong rat studies, mazdutide caused thyroid C-cell tumours; it is not known whether this happens in people. It must not be used by anyone with a personal or family history of medullary thyroid cancer (MTC) or with multiple endocrine neoplasia type 2 (MEN 2). Tell your doctor about a lump in the neck, trouble swallowing, breathlessness or a hoarse voice that does not go away.

  • Stomach and gut effects: these are the most common side effects. In the diabetes trials, diarrhoea affected 34.5% (4 mg) and 34.9% (6 mg), nausea 31.3% and 33.4%, and vomiting 20.4% and 25.1%, against 11.2%, 0.9% and 1.9% on placebo. Most were mild to moderate, happened while the dose was being increased and eased afterwards. Only 0.6% (4 mg) and 2.0% (6 mg) stopped treatment for this reason.
  • Dehydration and kidneys: heavy vomiting or diarrhoea can lead to dehydration and, in severe cases, kidney injury. Drink enough fluids and report persistent symptoms.
  • Low blood sugar: on its own the risk was low, and no severe episodes were reported. The risk is higher when it is combined with a sulfonylurea or insulin.
  • Pancreas and gallbladder: stop the injection and seek care for severe, lasting stomach pain that may spread to the back. Gallstone problems were reported rarely.
  • Heart rate: resting heart rate rose by an average of 3.5 to 3.9 beats a minute in the diabetes trials. Report a racing heartbeat at rest.
  • Eyes: a fast drop in blood sugar can briefly worsen diabetic retinopathy. People with existing eye disease need regular eye checks.
  • Surgery and sedation: because it slows the stomach, tell the anaesthetist you are using it before any procedure under general anaesthesia or deep sedation.
  • Mood: the label asks doctors to watch for low mood or suicidal thoughts, as reported with other weight-control medicines.

Pregnancy and breastfeeding: it must not be used in pregnancy or while breastfeeding. Because it stays in the body for a long time, stop it at least 3 months before a planned pregnancy. Its safety in people under 18 has not been established, and experience in those over 65 with the weight indication is limited.

How to Access Mazdutide in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Mazdutide to India?

The pens can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified endocrinologist, diabetologist or physician
  • Recent reports confirming the diagnosis, such as HbA1c and blood sugar results for type 2 diabetes, or BMI and related test results for weight management, with details of current medicines
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Mazdutide available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. The pre-filled pens must be kept at 2°C to 8°C, away from light, and must never be frozen, so they travel under temperature-controlled shipping to the patient or hospital. Because the dose steps up every four weeks, we plan each order around the pen strength the doctor has prescribed for that stage. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with refrigerated delivery arranged to the patient or treating clinic on a valid prescription.

Delhi

Endocrinology clinics here see patients from across North India, and our New Delhi dispatch point keeps the refrigerated journey short.

Mumbai

Pens can be delivered to the patient's home or to the treating clinic, packed to stay between 2°C and 8°C.

Bangalore

Diabetologists in Bangalore can send a named-patient request and receive a written quote before anything is ordered.

Chennai

A large diabetes care hub for South India, with experience in handling imported refrigerated injections.

Hyderabad

We time each delivery to the four-weekly dose steps, so the right pen strength arrives before it is needed.

Kolkata

Shipments to Kolkata and the eastern states are routed to keep the cold chain intact from dispatch to delivery.

Pune

Patients in Pune can use the same documented import route, with updates at each stage.

Ahmedabad

The treating doctor can send us the prescription and recent HbA1c reports to begin the import.

Jaipur

Patients in Rajasthan can have the pens delivered in insulated, temperature-logged packaging.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the home or treating clinic.

Lucknow

We coordinate cold-chain delivery to patients and hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the pens at home or at their clinic in Kochi and nearby cities.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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