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Gecacitinib

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Gecacitinib

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: Gecacitinib
Generic Name (API): Gecacitinib hydrochloride
Dosage Form & Strength: 50 mg
Route: Oral
Drug Class: JAK1/JAK2/JAK3/TYK2 and ACVR1 inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Gecacitinib Used For?

Gecacitinib is a tablet for myelofibrosis, a rare bone marrow cancer in which scar tissue slowly replaces the marrow that makes blood cells. It was discovered and is made in China by Suzhou Zelgen Biopharmaceuticals, and is sold there as 泽普平® (Ze Pu Ping). During its development it was known as jaktinib.

China's National Medical Products Administration (NMPA) approved it in May 2025 for adults with:

  • Intermediate- or high-risk primary myelofibrosis
  • Myelofibrosis that developed after polycythaemia vera (post-PV MF)
  • Myelofibrosis that developed after essential thrombocythaemia (post-ET MF)

In these patients it is used to treat an enlarged spleen or the symptoms caused by the disease. It is a prescription blood disorder medicine and should be started and monitored by a haematologist.

How It Works

In myelofibrosis, a signalling route inside blood cells called JAK-STAT is switched on all the time. This drives inflammation, a swollen spleen and tiredness, night sweats and other symptoms. Gecacitinib blocks the JAK enzymes (JAK1, JAK2, JAK3 and TYK2) to calm that signal down. It also blocks a second target, ACVR1, which helps control iron use in the body. The company says this second action may help with the anaemia that so many people with myelofibrosis live with.

What the Trial Showed

The approval rests on the ZGJAK016 phase 3 trial, run at 38 hospitals in China. It enrolled 105 adults with intermediate-2 or high-risk myelofibrosis who had never taken a JAK inhibitor; 71 received gecacitinib and 34 received a standard comparison tablet. The final results were published in Blood Cancer Journal in December 2024.

  • Spleen size: after 24 weeks, 64.8% of people on gecacitinib had their spleen shrink by at least 35%, against 26.5% in the comparison group.
  • Best spleen response at any point: 81.7% vs 32.4%.
  • Symptoms: 62.0% had their symptom score halved by week 24, compared with 50.0% (this difference was not statistically significant).
  • Haemoglobin: on average it rose slightly on gecacitinib (+1.27 g/L) and fell in the comparison group (−3.5 g/L) by week 24.

Recommended Dosage

Each tablet contains 50 mg. In the phase 3 trial the dose was 100 mg twice a day by mouth, which is two tablets in the morning and two in the evening. Treatment was paused if the platelet count fell below 50 × 10⁹/L and restarted once it recovered. Your haematologist will confirm the dose against the Chinese prescribing information and adjust it to your blood counts.

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

Warnings and Precautions

Blood counts: low blood counts were the most common side effects in the phase 3 trial. Low platelets affected 38.0% of people on gecacitinib (severe in 15.5%) and anaemia 36.6% (severe in 26.8%). Both were less frequent than in the comparison group. Your full blood count is checked regularly, and treatment is paused if platelets drop too low.

  • Blood pressure: high blood pressure was seen in 12.7% (severe in 7.0%), and none in the comparison group. Have your blood pressure checked during treatment.
  • Kidney and liver tests: raised creatinine occurred in 19.7% and raised ALT (a liver enzyme) in 16.9%. Blood tests are used to keep an eye on both.
  • Infections: upper respiratory infections (15.5%), urinary infections (8.5%) and pneumonia (5.6%) were reported. Tell your doctor quickly about fever, cough or burning when passing urine.
  • Other effects: diarrhoea (14.1%) and fever (12.7%) were also common.
  • Disease progression: 3 of the 71 patients (4.2%) developed leukaemia during follow-up, which can happen in myelofibrosis itself. Your doctor will keep monitoring your blood and marrow.

Overall: serious side effects occurred in 26.8% of people on gecacitinib and 41.2% in the comparison group, and 7.0% stopped treatment because of side effects (against 11.8%). Safety in pregnancy, breastfeeding and children has not been established. Tell your doctor about every other medicine you take.

How to Access Gecacitinib 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 Gecacitinib 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 haematologist
  • Diagnostic reports confirming myelofibrosis (for example, bone marrow biopsy and risk score), with recent blood counts
  • 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 Gecacitinib 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. For other myelofibrosis medicines we can import, see our pages on Ojjaara and Vonjo.

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 tablets are kept in their original sealed packs and stored as directed on the pack, and they travel in protective packaging. Because treatment is taken every day, we can plan repeat supplies so there is no gap 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 hospital on a valid specialist's prescription.

Delhi

Large haematology departments here see myelofibrosis patients from across North India, and supplies leave from our New Delhi dispatch point.

Mumbai

Tablets can be delivered to the patient's home or the treating hospital, with the paperwork checked before dispatch.

Bangalore

Haematologists in Bangalore can send a named-patient request, and the written quote comes before any order is placed.

Chennai

A major referral centre for blood disorders in South India, where long-term oral treatment can be supplied month by month.

Hyderabad

We line up each refill around the patient's blood test schedule, so the next pack arrives on time.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route.

Pune

The treating doctor can share the prescription and recent reports with us to begin the import.

Ahmedabad

Deliveries to Ahmedabad are tracked, with updates shared at each stage.

Vellore

Patients followed at hospitals in Vellore can have supplies sent directly to them or to the hospital pharmacy.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh who are under a haematologist's care.

Lucknow

We coordinate delivery to public and private hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive their tablets 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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