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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Sitokiren on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
China
Regulatory Approval:
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Sitokiren is a new once-a-day tablet for high blood pressure that works at the very first step of the body's blood-pressure hormone system. It was discovered by Shanghai Pharmaceuticals Holding Co., Ltd., where it was known as SPH3127, and is made and licensed in China by its subsidiary Shanghai Sine Pharmaceutical Laboratories Co., Ltd. Its Chinese name is 苹果酸司妥吉仑片 (sitokiren malate tablets).
China's National Medical Products Administration (NMPA) approved it in December 2025 (approval no. 国药准字H20250067) as a Class 1 new chemical drug for:
It is a prescription heart and blood-pressure medicine and should be started and monitored by a doctor.
The kidneys release an enzyme called renin, which sets off a chain reaction (the renin-angiotensin-aldosterone system, or RAAS) that tightens blood vessels and makes the body hold on to salt and water. Sitokiren is a small-molecule direct renin inhibitor: it blocks renin itself, so the chain is stopped at its first, rate-limiting step. Shanghai Pharmaceuticals reports that, in laboratory and animal studies, it blocked renin activity more strongly than an older medicine aimed at the same target.
In the phase 3 trial, published in Drugs in 2026, 828 adults with mild-to-moderate essential hypertension took either sitokiren 100 mg or an established blood-pressure medicine from the angiotensin receptor blocker group, once a day for 12 weeks. The fall in sitting diastolic (lower) blood pressure was 5.97 mmHg with sitokiren and 6.32 mmHg with the comparison medicine, which met the trial's pre-set test for being no worse (non-inferior). In the first, dose-finding stage of the trial, this dose cut plasma renin activity by about 83%.
In an earlier placebo-controlled phase 2 trial of 122 patients (Hypertension Research, 2024), 100 mg a day lowered sitting blood pressure by 13.8/8.6 mmHg after 8 weeks, against 7.7/3.1 mmHg on placebo.
The approved tablet strength is 50 mg. In the trials:
The exact dose and how to take it should follow the Chinese prescribing information and your doctor's advice.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Overall safety: in the phase 3 trial, side effects that doctors linked to the medicine were reported in 8.3% of people on sitokiren and 10.0% on the comparison medicine. None of these were serious or grade 3 or higher, and no one on sitokiren stopped treatment because of them.
Who was not studied: the trials did not include people with secondary or severe (grade 3) hypertension, serious heart disease in the previous 6 months, or poorly controlled diabetes, and pregnant and breastfeeding women were excluded. Its safety in pregnancy, breastfeeding and children has not been established, so tell your doctor if you are pregnant or planning a pregnancy.
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. Because blood-pressure treatment is long term, we can plan supply a few months at a time so there is no break in treatment.
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. Each tablet contains 50 mg, so the 100 mg daily dose used in the trials needs two tablets a day. The tablets travel in their sealed original packs, stored as directed on the Chinese pack, under temperature-controlled shipping. 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.
Cardiologists and physicians in Delhi see patients from across North India, and our New Delhi dispatch point keeps delivery times short.
Doctors in Mumbai can request the tablets for a named patient, with a few months' supply planned in one order.
Patients in Bangalore can have the tablets delivered home or to their clinic once the documents are checked.
A major centre for cardiology in South India, with experience in managing imported medicines for individual patients.
Physicians in Hyderabad can share the prescription and recent blood tests with us to begin the import.
For Kolkata and the eastern states, we plan deliveries so the next supply arrives before the current one runs out.
Patients in Pune can use the same documented import route, with updates shared at every step.
The treating doctor can send us the prescription and blood-pressure records to start the process.
Patients in Rajasthan can receive the tablets without travelling, as long as the import is in their name.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating clinic.
We coordinate delivery for patients treated at public and private hospitals across Uttar Pradesh.
Patients across Kerala can have their supply delivered to their home or 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.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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