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Deutenzalutamide

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Deutenzalutamide

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: Deutenzalutamide
Generic Name (API): Deutenzalutamide
Dosage Form & Strength: 40 mg
Route: Oral
Drug Class: Second-generation androgen receptor inhibitor (deuterated)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Deutenzalutamide Used For?

Deutenzalutamide is an oral hormone-blocking medicine for advanced prostate cancer. It was developed in China by Hinova Pharmaceuticals, where it is sold as 海纳安®, and it is taken as soft capsules once a day.

China's National Medical Products Administration (NMPA) approved it in May 2025 for adult men with metastatic castration-resistant prostate cancer (mCRPC) who:

  • Have had their cancer grow after an earlier hormone tablet that blocks testosterone production, and after chemotherapy
  • Have not yet been treated with a newer-generation androgen receptor blocker

It is a prescription cancer medicine and should only be used under a urologist or medical oncologist.

How It Works

Prostate cancer cells grow when male hormones (androgens) attach to the androgen receptor inside the cell. Deutenzalutamide is a second-generation androgen receptor inhibitor: it blocks this receptor so the growth signal is switched off, even when the cancer no longer responds to castration alone. Some of its hydrogen atoms are replaced with deuterium, a heavier form of hydrogen. This slows the way the body breaks it down and, according to the developer, means less of it reaches the brain, which is linked to fewer side effects such as seizures and falls.

What the Trial Showed

The phase 3 HC-1119-04 trial, published in Signal Transduction and Targeted Therapy in 2026, included 417 men at 36 centres in China. All had already received the testosterone-blocking tablet, and about two-thirds had also had chemotherapy. Compared with placebo, deutenzalutamide lowered the risk of the cancer growing on scans, or death, by 42%. The median time to progression was 5.55 months against 3.71 months, but the benefit lasted in a meaningful group: 29% were still progression-free at 12 months, compared with 6%, and 18% at 24 months.

The main overall survival analysis did not show a clear difference (hazard ratio 0.95), largely because many men in both groups went on to other treatments. Analyses adjusting for those later treatments suggested a survival benefit (hazard ratios 0.65 to 0.73).

Recommended Dosage

  • 80 mg (two 40 mg soft capsules) once a day, by mouth
  • Can be taken with food or on an empty stomach
  • Hormone (androgen deprivation) therapy continues alongside it: a GnRH analogue injection, unless the testicles have been surgically removed
  • In the trial, the dose could be lowered to 40 mg once a day if side effects were a problem

If a dose is forgotten, take it as soon as you remember that day. If a whole day is missed, simply take the normal dose the next day; do not double up.

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

Warnings and Precautions

Anaemia: this was the most common side effect in the HC-1119-04 trial, affecting 44.2% of men on deutenzalutamide and 39.3% on placebo, and was severe in 16.4% against 10.7%. Blood counts are checked during treatment, so report tiredness, breathlessness or paleness.

  • Tiredness and appetite: fatigue (27.7% vs 30.0%), reduced appetite (27.0% vs 26.4%) and weight loss (24.5% vs 18.6%) were common in both groups, reflecting how advanced the cancer is.
  • Seizures and falls: no seizures or falls were reported in the trial. However, men with a history of seizures or brain metastases were not included, so tell your doctor if either applies to you.
  • Liver tests: raised ALT/AST was reported in 5.5% of patients (severe 0.7%) in the company's trial summary.
  • Other medicines: give your doctor a full list of the medicines and supplements you take, so that interactions can be checked.

Overall: severe side effects of any cause occurred in 52.9% of men on deutenzalutamide and 42.1% on placebo; severe side effects judged to be treatment-related occurred in 22.3% against 15.0%. 8.4% stopped because of side effects, compared with 7.9% on placebo. Deaths linked to adverse events were reported in 2.2% and 3.6% respectively. This medicine is for men only and has not been studied in children.

How to Access Deutenzalutamide 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 Deutenzalutamide to India?

The capsules 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 urologist or medical oncologist
  • Diagnostic reports confirming metastatic castration-resistant prostate cancer (PSA history, testosterone level and scans), with details of earlier hormone treatment and chemotherapy
  • 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 Deutenzalutamide 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 men whose prostate cancer carries HRR gene changes, our page on Talzenna covers another import option.

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. At two 40 mg capsules a day, a month of treatment needs about 60 capsules, and we plan supply so there is no break between orders. The capsules travel in their sealed original packs under temperature-controlled shipping and should then 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 hospital on a valid specialist's prescription.

Delhi

Urology and oncology centres in Delhi treat advanced prostate cancer patients from across North India, and dispatch from New Delhi keeps delivery quick.

Mumbai

Capsules can be delivered to the patient's home or the hospital pharmacy before the current supply runs out.

Bangalore

Uro-oncologists in Bangalore can request the medicine for a named patient, with the quote shared before ordering.

Chennai

Patients at Chennai's cancer hospitals can receive their monthly supply at the treating centre.

Hyderabad

We plan each shipment so the once-daily capsules continue without interruption.

Kolkata

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

Pune

Families in Pune receive updates at every step, from prescription check to delivery.

Ahmedabad

The treating doctor can send the prescription, PSA history and scan reports to start the import.

Vellore

Supply for patients treated in Vellore can be sent directly to the hospital.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating hospital.

Lucknow

We coordinate delivery to urology and cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive their capsules 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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