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Crisugabalin

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Crisugabalin

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: Crisugabalin
Generic Name (API): Crisugabalin Besilate
Dosage Form & Strength: 20 mg
Route: Oral
Drug Class: GABA analogue, calcium channel alpha-2-delta ligand

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Crisugabalin Used For?

Crisugabalin is a twice-a-day capsule for long-lasting nerve pain. It was discovered and developed in China by Haisco Pharmaceutical Group, where it is sold as 思美宁® and was known in trials by the code HSK16149.

China's National Medical Products Administration (NMPA) approved it in May 2024, and the current Chinese label covers adults with:

  • Diabetic peripheral neuropathic pain: burning, shooting or tingling pain in the feet and legs caused by nerve damage from diabetes
  • Post-herpetic neuralgia: nerve pain that carries on after a shingles rash has healed

It is a prescription neurology medicine and should be started and reviewed by a neurologist, pain specialist, diabetologist or dermatologist.

How It Works

Crisugabalin is built on the shape of GABA, one of the brain's natural calming messengers, but it does not act on GABA receptors themselves. Instead, it attaches to a part of the calcium channels on over-active pain nerves known as the alpha-2-delta subunit. The label is honest that its exact mechanism is not fully understood. In practice, it quietens the faulty pain signals that damaged nerves keep sending.

What the Trials Showed

Diabetic nerve pain: a phase 2/3 trial in China, published in JAMA Network Open in 2024, treated patients for 13 weeks. Average daily pain scores (0 to 10) fell by 2.24 points on 20 mg twice daily and 2.16 points on 40 mg twice daily, against 1.23 points on placebo. More than half of patients on the lower dose (57.3%) had their pain cut by at least 30%, compared with 31.6% on placebo.

Post-shingles nerve pain: a phase 3 trial of 366 adults, published in JAMA Dermatology in 2024, ran for 12 weeks. Pain scores fell by about 2.3 points on 20 mg twice daily and 2.5 points on 40 mg twice daily, against about 1.0 point on placebo. At least a 30% drop in pain was seen in 61.2% and 54.5% of patients on the two doses, compared with 35.5% on placebo.

Recommended Dosage

According to the Chinese label, it can be taken with or without food:

  • Diabetic nerve pain: 20 mg twice a day. If pain is not controlled well enough and the medicine is well tolerated, the doctor may carefully raise it to 40 mg twice a day.
  • Post-shingles nerve pain: 20 mg or 40 mg twice a day, adjusted to response and tolerance.
  • Kidneys: the daily dose is halved in moderate and cut to a quarter in severe kidney impairment. No change is needed for liver problems.
  • No slow build-up of the dose is needed at the start.

Side effects rise with dose, so your doctor will use the lowest dose that controls the pain.

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

Warnings and Precautions

Dizziness and sleepiness: these are the main side effects. Across the two controlled trials, dizziness affected 22.7% of people on crisugabalin against 5.7% on placebo, and sleepiness 7.5% against 0.3%. About 8 in 10 of these episodes began in the first week, and almost all were mild to moderate. Do not drive or use machines until you know how it affects you.

  • Weight gain: a gain of 7% or more of body weight was seen in 4.0% of patients, against 1.6% on placebo. People with diabetes should keep an eye on weight and blood sugar.
  • Swelling: mild ankle or leg swelling (peripheral oedema) occurred in 1.7% of patients, against 0.8% on placebo.
  • Kidneys: the medicine leaves the body mainly unchanged through the kidneys, so kidney function guides the dose. Abnormal kidney results were reported in 1.5% (placebo 0.3%).
  • Liver tests: mild rises in liver enzymes were seen in a small number of patients and settled without treatment.
  • Allergy: one patient developed a rash that cleared after stopping. Stop and seek advice if you notice signs of an allergic reaction.
  • Misuse: no abuse or dependence was seen in the trials, but as with any medicine acting on the nervous system, your doctor will check your history and watch for misuse.

Stopping because of side effects: 5.1% of patients in the diabetic nerve pain trial (placebo 1.1%) and 2.0% in the post-shingles trial (placebo 0%). It is not recommended in pregnancy or breastfeeding, and safety in under-18s has not been established.

How to Access Crisugabalin 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 Crisugabalin 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 neurologist, pain specialist, diabetologist or dermatologist
  • Medical records confirming diabetic peripheral neuropathic pain or post-herpetic neuralgia, with a recent kidney function test
  • 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 Crisugabalin 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 another pain medicine that we import on prescription, see our page on Journavx.

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 20 mg capsules are stored sealed at no more than 25°C and travel in their original blister packs under temperature-controlled shipping. At 20 mg twice a day, one month of treatment is about 60 capsules, so we plan quantities around your prescribed dose. 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

Diabetes and pain clinics in the capital see many people with burning foot pain, and our New Delhi dispatch point means short delivery times.

Mumbai

Capsules can be sent to the patient's home or the treating clinic once the prescription and papers are checked.

Bangalore

Pain specialists and diabetologists in Bangalore can request the medicine for a named patient, with a quote shared before ordering.

Chennai

With a large diabetes population, Chennai patients with long-standing nerve pain can use the same documented import route.

Hyderabad

We plan monthly or longer supplies so treatment is not interrupted between refills.

Kolkata

Deliveries to Kolkata and the eastern states travel in sealed original packs with tracking at each step.

Pune

Patients with nerve pain after shingles can have their supply arranged on a dermatologist's or neurologist's prescription.

Ahmedabad

The treating doctor can send us the prescription and kidney test report to start the import.

Vellore

Patients under specialist care in Vellore can receive the medicine at home or at the hospital pharmacy.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to their address or clinic.

Lucknow

We coordinate delivery to patients and clinics 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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