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Retagliptin

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Retagliptin

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: Retagliptin
Generic Name (API): Retagliptin Phosphate
Dosage Form & Strength: 50 mg, 100 mg
Route: Oral
Drug Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Retagliptin Used For?

Retagliptin is a once- or twice-daily tablet for type 2 diabetes, developed in China by Jiangsu Hengrui Pharmaceuticals and sold there as 瑞泽唐® (Ruizetang). It is the first medicine of its type, a DPP-4 inhibitor, to be discovered and developed in China.

China's National Medical Products Administration (NMPA) approved it in June 2023 to improve blood sugar control in adults with type 2 diabetes:

  • On its own, alongside diet and exercise
  • Together with metformin, when metformin alone is not controlling blood sugar well enough

It is a prescription diabetes and hormone medicine and should be used under an endocrinologist, diabetologist or physician.

How It Works

After a meal, the gut releases hormones called incretins, mainly GLP-1, that tell the pancreas to release insulin and hold back glucagon. An enzyme called DPP-4 quickly breaks these hormones down. Retagliptin blocks DPP-4, so the body's own GLP-1 lasts longer. Because this effect depends on blood sugar being raised, it lowers glucose with a low risk of hypoglycaemia (low blood sugar) when used without other sugar-lowering medicines that cause it.

What the Trials Showed

  • On its own: in the 24-week SP2086-301 trial (340 patients completed the main phase), HbA1c fell by 0.90% more than placebo with 50 mg twice a day and by 0.76% more with 100 mg once a day.
  • With metformin: in the SP2086-303 trial of 371 patients, adding 50 mg twice a day lowered HbA1c by 0.62% more than placebo over 24 weeks. 40.5% reached an HbA1c below 7%, against 20.5% on placebo.
  • 100 mg once a day with metformin: a separate phase 3 trial of 174 patients, published in Diabetes, Obesity and Metabolism (2024), found HbA1c fell by 0.82% more than placebo at 16 weeks, with no severe hypoglycaemia.

Recommended Dosage

  • 100 mg once a day, or 50 mg twice a day
  • Can be taken with or without food
  • Moderate kidney impairment (creatinine clearance 30–59 mL/min): 50 mg once a day
  • Severe kidney impairment (creatinine clearance 29 mL/min or less): not recommended; if it is used, kidney function must be watched closely
  • No dose change is needed for mild kidney impairment (60–89 mL/min)

Kidney function should be checked before starting and regularly afterwards. It has not been studied in people with liver impairment. Your doctor sets the exact 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

Kidney function: the dose depends on how well the kidneys work, so a kidney test is needed before starting and at regular intervals. In severe kidney impairment it is not recommended.

  • Low blood sugar: in the phase 3 trials, hypoglycaemia occurred in under 2% of people taking it alone and in 2.4% of those also taking metformin, with no severe episodes. It is approved for use on its own or with metformin, so tell your doctor about any other diabetes medicines you take, and learn the signs of low sugar: sweating, shaking, hunger, confusion.
  • Pancreas: pancreatitis is an adverse event of special interest for all DPP-4 inhibitors. In one trial, slightly more patients on retagliptin had raised pancreatic enzymes (lipase and amylase) than on placebo. Seek medical help promptly if you get severe, lasting stomach pain, with or without vomiting.
  • Skin: serious skin reactions are another event watched for with this class. Report any blistering or widespread rash.
  • Liver: it has not been studied in people with liver impairment.
  • Type 1 diabetes: it is approved only for adults with type 2 diabetes.

Side effects in the trials: side effects were uncommon. Over 24 weeks, the only ones seen in at least 1% of patients and more often than with placebo were sore throat (pharyngitis, 1.6%) and dizziness (1.6%), both in the 100 mg once-daily group. Over 52 weeks, raised uric acid (1.3%) was also reported with 50 mg twice a day. In the 2024 add-on trial, no one stopped treatment permanently because of side effects. Safety in pregnancy, breastfeeding and children has not been established in the published data, so discuss this with your doctor first.

How to Access Retagliptin 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 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 Retagliptin to India?

The tablets 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, including HbA1c, fasting blood sugar and a kidney function test (creatinine or eGFR)
  • 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 Retagliptin 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. Because diabetes treatment is long term, your doctor will plan supply in regular batches.

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. It comes as 50 mg and 100 mg tablets, and the strength we order depends on whether your doctor prescribes 100 mg once a day, 50 mg twice a day or the lower kidney dose. The tablets travel in their sealed original packs under temperature-controlled shipping and should be stored as directed on the pack. 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 the treating clinic on a valid doctor's prescription.

Delhi

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

Mumbai

Diabetologists in Mumbai can request the medicine for a named patient and set up repeat supplies so there is no break in treatment.

Bangalore

Patients in Bangalore can have the tablets delivered home once the prescription and kidney test are checked.

Chennai

Chennai has a large community of diabetes specialists, who can share the prescription and HbA1c report with us to begin the import.

Hyderabad

Endocrinologists in Hyderabad can coordinate access, with a written quote shared before anything is ordered.

Kolkata

For Kolkata and the eastern states, we plan each batch so the next one arrives before the current supply runs out.

Pune

Patients in Pune can use the same documented import route, with updates at every step.

Ahmedabad

Physicians in Ahmedabad can arrange supply for patients who need this specific medicine.

Jaipur

Patients in Jaipur and across Rajasthan can receive the tablets at home or at their clinic.

Chandigarh

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

Lucknow

We coordinate deliveries to patients and hospitals across Uttar Pradesh after the paperwork is complete.

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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