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Manufacturer / Innovator:
China
Regulatory Approval:
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Ruzinurad is a new tablet for gout that lowers uric acid by helping the kidneys pass more of it out in the urine. It was discovered and developed in China by Jiangsu Hengrui Pharmaceuticals, where it is sold as Ruzinurad Tablets (鲁兹诺雷钠片, research code SHR4640).
China's National Medical Products Administration (NMPA) approved it in May 2026 for:
It belongs with other immunology and rheumatology medicines and should be started and monitored by a rheumatologist or a doctor experienced in treating gout.
Gout happens when uric acid builds up and forms sharp crystals in the joints. About two-thirds of the uric acid the body makes leaves through the kidneys, and a transporter called URAT1 handles roughly 90% of the uric acid the kidneys pull back into the blood. Ruzinurad blocks URAT1 very selectively, so less uric acid is reabsorbed, more is passed out, and the blood level falls. Hengrui describes it as China's first home-grown, highly selective URAT1 inhibitor.
The key phase 3 study, presented at the EULAR 2025 congress, compared ruzinurad with a standard urate-lowering comparison medicine in 773 people with gout (388 on ruzinurad, 385 on the comparison). After 16 weeks, 52.6% of people taking ruzinurad reached the target blood uric acid level of 360 µmol/L or lower, against 34.5% in the comparison group. Judged on the last two monthly readings, the figures were 39.7% and 26.5%. The researchers reported that the difference held up through week 52.
The tablets come in two strengths, 1 mg and 2.5 mg. In the phase 3 trials ruzinurad was taken by mouth once a day.
The approved starting dose and any step-up schedule are given in the Chinese package insert, which has not been published online in English. Your rheumatologist will confirm the exact dose before the first order.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Gout flares at the start: the most common side effect in the phase 3 study was a gout flare. Flares are common in the early months of any urate-lowering treatment. Ask your doctor how to manage a flare, and do not stop ruzinurad on your own if one happens.
Overall: over the 52-week treatment period, 89.7% of people on ruzinurad and 91.7% on the comparison medicine had at least one side effect, most of them mild or moderate. Serious side effects occurred in 4.9% and 3.1%, and the researchers reported no new safety concerns. Pregnant and breastfeeding women were not included in the trials, so safety in pregnancy and breastfeeding has not been established. Tell your doctor if you are pregnant, planning a pregnancy or breastfeeding.
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.
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:
Once we have received and checked a valid prescription and, where needed, an import permit.
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. NPP also arranges other rheumatology imports, such as Ilaris and Kineret.
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.
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. Because urate-lowering treatment is long term, we can plan supplies in blocks of a few months, matched to the strength your doctor prescribes. 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.
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.
Rheumatology clinics here see a large number of gout patients, and our New Delhi dispatch point means short delivery times.
Tablets can be sent to the patient's home or to the treating clinic once the prescription is checked.
Rheumatologists in Bangalore can request the medicine for a named patient and receive a written quote first.
Patients in Chennai can use the same documented import route, with updates at each stage.
We can line up repeat supplies so there is no gap in long-term uric acid control.
Deliveries to Kolkata and the eastern states are tracked from dispatch to doorstep.
The treating doctor can share the prescription and uric acid reports with us to start the import.
Patients across Gujarat can have the tablets delivered to their home or clinic in Ahmedabad.
We help patients in Rajasthan with paperwork and timelines before anything is ordered.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or clinic.
We coordinate delivery to patients and hospitals across Uttar Pradesh.
Patients across Kerala can receive their supply in Kochi and nearby cities.
Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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