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Ivarmacitinib

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Ivarmacitinib

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: Ivarmacitinib
Generic Name (API): Ivarmacitinib sulfate
Dosage Form & Strength: 4 mg
Route: Oral
Drug Class: Selective JAK1 inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Ivarmacitinib Used For?

Ivarmacitinib is a once-daily tablet that calms an overactive immune system. It was developed in China by Jiangsu Hengrui Pharmaceuticals, where it is sold as 艾速达® and is also known by its research code SHR0302. It is used across several long-term inflammatory conditions of the joints, spine and skin.

China's National Medical Products Administration (NMPA) has approved it for adults with:

  • Active ankylosing spondylitis that has not responded well to, or could not be tolerated with, one or more TNF inhibitors (March 2025)
  • Moderate to severe active rheumatoid arthritis that has not responded well to, or could not be tolerated with, one or more TNF inhibitors (March 2025)
  • Moderate to severe atopic dermatitis (eczema) not controlled by creams or other systemic treatments, or where these could not be tolerated (April 2025)
  • Severe alopecia areata (patchy or total hair loss) (June 2025)
  • Active non-radiographic axial spondyloarthritis with signs of inflammation (raised CRP and/or MRI changes) after a poor response to, or intolerance of, NSAID painkillers (August 2026)

It is a prescription immunology medicine and should be started and monitored by a rheumatologist or dermatologist.

How It Works

Many inflammatory signals pass their message into immune cells through enzymes called Janus kinases (JAKs). Ivarmacitinib is a highly selective blocker of JAK1, so it turns down several of these inflammatory signals at once. This reduces joint swelling and back pain in arthritis, itching and rash in eczema, and the immune attack on hair follicles in alopecia areata.

What the Trials Showed

  • Rheumatoid arthritis: in a phase 3 trial of 566 patients whose arthritis was not controlled by standard DMARD tablets, 70.4% on 4 mg and 75.1% on 8 mg reached ACR20 (at least 20% improvement) at week 24, compared with 40.4% on placebo.
  • Ankylosing spondylitis: in a phase 2/3 trial, 48.7% on 4 mg reached ASAS20 at week 12 against 29.0% on placebo, and 32.1% against 18.3% reached ASAS40.
  • Atopic dermatitis: in a phase 3 trial of 336 patients, EASI-75 (75% clearer skin) at week 16 was reached by 54.0% on 4 mg and 66.1% on 8 mg, compared with 21.6% on placebo.
  • Alopecia areata: in a phase 3 trial of 330 adults with at least 50% scalp hair loss, 34.9% on 4 mg and 40.6% on 8 mg had 80% or more scalp coverage (SALT 20 or less) at week 24, against 9.0% on placebo.

Recommended Dosage

It is taken by mouth once a day. The tablets in China are 4 mg. In the trials:

  • Ankylosing spondylitis: 4 mg once daily
  • Rheumatoid arthritis, atopic dermatitis and alopecia areata: 4 mg or 8 mg once daily were tested

The approved dose for each condition is set out in the Chinese prescribing information, and your specialist will decide the right dose for you.

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

Warnings and Precautions

Infections: because it damps down the immune system, infections can be more likely. In the rheumatoid arthritis trial, infection-related side effects were slightly more common than with placebo. In the eczema trial, upper respiratory tract infections affected about 11% in every group, shingles (herpes zoster) occurred in 2.7% on 4 mg and 0.9% on 8 mg (none on placebo), and serious infections in 1.8% on 4 mg. Report fever, cough, painful blisters or any infection that will not settle.

  • Blood tests: in the eczema trial, a rise in the muscle enzyme CPK was seen in 7.1% (4 mg) and 10.7% (8 mg) against 0.9% on placebo, and raised blood fats in 1.8% and 7.1%. Falls in platelets and neutrophils and rises in cholesterol and triglycerides were also seen but were described as short-lived. Your doctor will arrange regular blood tests.
  • Skin: acne and folliculitis were more common on the 8 mg dose (6.3% and 7.1%).
  • Overall side effects: in the rheumatoid arthritis trial, side effects of any kind occurred in 81.5% (4 mg) and 90.5% (8 mg) against 79.3% on placebo; in the ankylosing spondylitis trial, 79.7% against 65.6%.
  • Serious events: in the eczema and alopecia trials no blood clots, major heart events or deaths were reported, but these trials were short. JAK inhibitors as a group need care in people with heart disease, past blood clots or cancer, so tell your doctor about your full medical history.

Safety in pregnancy and breastfeeding has not been established. Discuss contraception with your doctor before starting.

How to Access Ivarmacitinib 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 Ivarmacitinib 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 rheumatologist or dermatologist
  • Medical reports confirming the diagnosis (for example CRP, X-ray or MRI for spondyloarthritis, or disease scores for eczema or alopecia) and details of earlier treatments
  • 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 Ivarmacitinib 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. You can also read about Litfulo for alopecia areata and Orencia for rheumatoid arthritis on our site.

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 4 mg tablets stay in their sealed original packs, stored as directed on the pack, and travel under temperature-controlled shipping. As it is a once-daily, long-term treatment, we can plan repeat supplies so there is no break between packs. 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 specialist's prescription.

Delhi

Rheumatology and dermatology centres here treat patients from across North India, and our New Delhi dispatch point keeps delivery quick.

Mumbai

Specialists in Mumbai can share the prescription and reports with us to begin the import in the patient's name.

Bangalore

Patients in Bangalore receive a clear written quote first, then delivery to home or the clinic.

Chennai

A major referral centre for arthritis and skin disease in South India, familiar with imported medicines for named patients.

Hyderabad

We set up regular resupply for patients in Hyderabad so the daily dose is never missed.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route, with updates at each step.

Pune

The tablets can be delivered to Pune once the prescription and permit are in order.

Ahmedabad

Doctors in Ahmedabad can check availability with us before finalising the treatment plan.

Vellore

Patients followed up at hospitals in Vellore can have supplies sent to the treating team or to their home.

Chandigarh

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

Lucknow

We coordinate delivery for patients treated at rheumatology and skin clinics across Uttar Pradesh.

Kochi

Patients across Kerala can receive each 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.

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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