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Visepegenatide

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Visepegenatide

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: Visepegenatide
Generic Name (API): Visepegenatide
Dosage Form & Strength: 0.97 mg
Route: Subcutaneous (SC) injection
Drug Class: Long-acting PEGylated GLP-1 receptor agonist

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Visepegenatide Used For?

Visepegenatide is a once-weekly injection that helps adults with type 2 diabetes keep their blood sugar under control. It was developed in China by PegBio, a Hangzhou-based company, and is sold there as 派达康® (Paidakang®), with Shanghai Tenry Pharmaceutical handling sales. One thing sets it apart for patients: it is given at the same fixed dose from the very first week, with no step-by-step dose increases.

China's National Medical Products Administration (NMPA) approved it on 12 November 2025 (approval number 国药准字 H20250066) for blood sugar control in adults with type 2 diabetes:

  • On its own: when diet and exercise alone have not brought blood sugar under control
  • With metformin: when blood sugar is still not controlled on metformin, alongside diet and exercise

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

How It Works

After you eat, your gut releases a hormone called GLP-1. It prompts the pancreas to release insulin when blood sugar is high. Natural GLP-1 is broken down quickly by an enzyme called DPP-4. Visepegenatide is a GLP-1 receptor agonist with a polyethylene glycol (PEG) chain attached at one precise spot. A 23 kDa PEG molecule is joined to the end of the peptide chain. According to PegBio, this shields it from DPP-4 and slows its removal by the kidneys, so a single injection keeps working for a full week.

What the Trials Showed

Two phase 3 trials in China were published in The Lancet Regional Health – Western Pacific in 2024:

  • On its own (273 people): after 24 weeks HbA1c fell by 1.36% with visepegenatide against 0.63% with placebo. Half of those treated (50.4%) reached an HbA1c below 7%, compared with 14.2%. The effect held at 52 weeks (a fall of 1.39%).
  • Added to metformin (620 people): after 24 weeks HbA1c fell by 1.25% against 0.68% with placebo, and 40.5% reached an HbA1c below 7%, compared with 17.9%.

Average starting HbA1c was about 8.5% in both trials. Weight change overall was small (around half a kilogram), though in people with a BMI of 32 or more the monotherapy group lost 5.1 kg on average at 24 weeks, against 1.7 kg on placebo.

Recommended Dosage

According to the Chinese prescribing information:

  • On its own: 0.97 mg injected under the skin once a week
  • With metformin: 0.97 mg once a week, while the current metformin dose is usually continued
  • No titration: treatment starts at the full dose; there is no low starting dose to step up from
  • Pen: each pre-filled pen delivers 0.3 mL containing 0.97 mg, through a hidden needle

Why do the trials say 150 micrograms? The label explains that 0.97 mg of visepegenatide (the whole PEG-linked molecule) equals 0.15 mg of the peptide part. The published trials describe the same weekly dose by its peptide content, so 0.97 mg and 150 µg are one and the same dose.

Your doctor will decide whether to use it on its own or with metformin, and will check HbA1c regularly to see how well it is working.

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

Warnings and Precautions

Stomach and gut effects: these were the most common side effects, but they were less frequent than many people expect with this type of medicine. In the trial where it was used on its own, nausea affected 8.0%, vomiting 5.8% and diarrhoea 8.0% (placebo 0.7%, 0% and 1.5%). When it was added to metformin, the rates were 4.2%, 4.8% and 7.4%. Eating smaller meals and stopping when full can help. Report vomiting or diarrhoea that does not settle, as it can lead to dehydration.

  • Low blood sugar: mild low blood sugar occurred in 4.4% on monotherapy (placebo 0.7%) and 2.6% with metformin (placebo 3.2%). No severe episodes were reported. The risk can be higher if it is combined with insulin or a sulfonylurea, so your doctor may adjust those doses.
  • Pancreas: one case of acute pancreatitis in the trial extension was judged to be related to treatment. Seek medical help for severe, lasting stomach pain that may spread to the back.
  • Stopping treatment: 3.6% stopped because of side effects in the monotherapy trial (placebo 0.7%), and 1.9% in the metformin trial (placebo 0.3%), mostly because of stomach symptoms.
  • Serious side effects: these were reported in 2.9% of people in the metformin trial, compared with 3.9% on placebo. No deaths occurred over 52 weeks of the monotherapy trial.

Who Should Not Use It

The Chinese prescribing information says it must not be used by:

  • Anyone allergic to visepegenatide or any ingredient in the pen
  • People with a personal or family history of medullary thyroid cancer (MTC), or with multiple endocrine neoplasia type 2 (MEN 2)
  • Pregnant women, and women who are breastfeeding

The label also notes that, in the trials, stomach side effects were mostly mild or moderate and appeared mainly in the first four weeks. If it is used with insulin or a sulfonylurea, the doctor should consider lowering the dose of those medicines to reduce the risk of low blood sugar.

Before starting: tell your doctor about any history of pancreatitis, thyroid problems, kidney problems or serious stomach disease, and if you are planning a pregnancy. Read the full warnings in the Chinese prescribing information supplied with the pack, and use it only under medical supervision.

How to Access Visepegenatide 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 Visepegenatide 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 type 2 diabetes, such as HbA1c and blood sugar results, with a list of current diabetes 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 Visepegenatide 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 pens are shipped and kept as directed on the pack, with temperature-controlled shipping used where the label requires it. Because the dose is the same every week, supply can be planned in simple multi-week batches. 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 delivery arranged to the patient or treating clinic on a valid prescription.

Delhi

Diabetes clinics in the capital see patients from across North India, and our New Delhi dispatch point keeps delivery times short.

Mumbai

Pens can be delivered to the patient's home or the treating clinic, with tracking at each step.

Bangalore

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

Chennai

Patients across Tamil Nadu can use the same documented import route through Chennai.

Hyderabad

With a fixed weekly dose, we can deliver several weeks of pens together to cut down on repeat orders.

Kolkata

Shipments to Kolkata and the eastern states are packed and handled as directed on the label.

Pune

The treating doctor can share the prescription and HbA1c reports with us to start the import.

Ahmedabad

Patients in Gujarat receive regular updates from order to delivery.

Jaipur

Patients in Rajasthan can have the pens delivered to their home or clinic.

Chandigarh

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

Lucknow

We coordinate delivery to patients and hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the medicine 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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