Cenobamate Tablets in India: New Epilepsy Medicine Explained

A patient-friendly guide by RealMedVision.
Medically reviewed | 10 to 12 min read

Cenobamate tablets for focal seizures in adults

India has a new option for adults whose focal seizures do not settle with common medicines. In mid August 2026, Bajaj Healthcare announced that the Drugs Controller General of India has cleared it to make and sell cenobamate tablets, the first such clearance for cenobamate in India. The medicine has been in use in the United States since 2020 as Xcopri and in Europe as Ontozry. With no Indian approval until then, patients here depended on personal import of these foreign brands. This guide covers what cenobamate tablets treat, how they work, side effects, safety rules and the price position.

  • Cenobamate is a prescription medicine for partial onset seizures, also called focal seizures, in adults.
  • Bajaj Healthcare announced DCGI approval in mid August 2026 to make and sell cenobamate tablets in India.
  • Six strengths are approved: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.
  • Doctors start at a very low dose and raise it slowly every two weeks.
  • Sleepiness, dizziness, tiredness and headache are the most reported side effects.
  • The Indian brand name and MRP have not been announced yet.

Why Cenobamate Is in the News in India

The approval came in two steps. On 26 June 2026, the CDSCO expert committee for neurology and psychiatry recommended granting Bajaj Healthcare permission to manufacture and market cenobamate tablets, a first for any Indian company, per its exchange filing. In mid August 2026, the company announced final DCGI approval covering the raw material and all six strengths, with plans to reach the market immediately.

Around 10 million people live with epilepsy in India, and about 3 million of them have drug resistant epilepsy, where seizures continue despite proper trials of standard medicines. [Awiqli Insulin Price]

How Cenobamate Tablets Work

Seizures happen when brain cells fire in a fast, uncontrolled burst. Most seizure medicines quiet this storm through one main pathway. Cenobamate works through two at once.

It calms sodium channels, the tiny gates that let brain cells fire again and again, and it supports GABA, the brain’s natural calming chemical. The excite signal drops while the calm signal gets a lift.

Widely used options such as carbamazepine or phenytoin mainly act on sodium channels alone. Researchers believe the dual approach helps explain the seizure freedom numbers seen in cenobamate trials.

Who Can Take Cenobamate Tablets

Who can take cenobamate tablets for focal seizures

Cenobamate suits adults with focal seizures whose current treatment is not giving full control. Under the US prescribing information, it can be given alone or added to existing seizure medicines. In India, a neurologist will decide who receives it, guided by the Indian label.

Some people should not take it at all. Anyone with a known allergy to cenobamate must avoid it, as must people with familial short QT syndrome, a rare inherited heart rhythm problem, because the medicine can shorten the heart’s QT interval. Share your heart, liver, kidney and mental health history with your doctor before starting.

Dose Strengths and the Start Low, Go Slow Rule

The approval covers the same six strengths used internationally, because treatment is built up in careful steps rather than started at full strength. The table shows the standard pathway from the US prescribing information. Your neurologist will set your personal plan.

Tablet strengthUsual place in the standard schedule
12.5 mgStarting dose, weeks 1 and 2
25 mgWeeks 3 and 4
50 mgWeeks 5 and 6
100 mgWeeks 7 and 8
150 mgWeeks 9 and 10
200 mgUsual maintenance dose from week 11

The dose is taken once daily, the usual maintenance level is 200 mg, and the maximum is 400 mg. For mild or moderate liver disease, the US label sets a lower maximum of 200 mg, and it is not recommended in severe liver disease. Only your doctor can decide the right dose and pace for you.

The slow climb is a safety rule, not a formality. In early studies where the dose was raised weekly or faster, a rare but dangerous allergic reaction called DRESS appeared, and one case was fatal. DRESS can involve fever, rash, swollen glands and organ injury. When a later study started 1339 patients at 12.5 mg with two week steps, no DRESS cases were reported. That does not prove the risk disappears, which is why the schedule must never be rushed.

Doctor’s Tip: 
Never adjust the dose on your own, and never double up after a missed tablet. Note it, take the next dose on time, and inform your doctor at the next visit.

How Well Does Cenobamate Work

Two large placebo controlled trials in adults with uncontrolled focal seizures back it. In an 18 week study in Lancet Neurology, about 21 in 100 people on the 400 mg dose had zero seizures during the 12 week maintenance phase, against 1 in 100 on placebo. At 200 mg, the figure was about 11 in 100. In a second trial in Neurology, about 28 in 100 people on cenobamate stayed seizure free during maintenance, against about 9 in 100 on placebo, and half of the treated group saw seizures fall by at least half.

Results varied widely between participants, the trials studied cenobamate as an add on in people whose seizures had resisted other medicines, and no seizure medicine works the same for everyone. Seizure freedom in roughly one out of five difficult cases is a strong trial signal, not a promise for any single patient.

An illustrative example, not a real case: Ramesh, 32, still gets four focal seizures a month despite two medicines at proper doses. Once cenobamate reaches pharmacies, his neurologist may weigh it as an add on, starting at 12.5 mg with two week reviews.

Side Effects of Cenobamate Tablets

Most reported effects touch the nervous system and tend to be dose related, another reason the dose climbs slowly. The figures come from the two main trials, and double vision is also commonly reported.

Side effectRoughly how many people reported it
Sleepiness or drowsinessAbout 22 to 25 in 100
DizzinessAbout 22 to 23 in 100
Tiredness or fatigueAbout 11 to 16 in 100
HeadacheAbout 11 to 12 in 100
NauseaAbout 11 in 100

Avoid driving, riding or operating machines until you know how it affects you. [Awiqli Dosase] Alcohol and sleeping pills add to the drowsiness, discuss both with your doctor.

Serious reactions are uncommon, and knowing the warning signs early protects you. DRESS usually begins with fever, rash or swollen glands. QT shortening is an ECG finding, and the US label asks patients to report warning signs such as prolonged strong palpitations or fainting. Like all antiseizure medicines, cenobamate carries a class warning for new or worsening depression and thoughts of self harm, so mood changes deserve quick attention. The US label also asks doctors to check liver blood tests, ALT, AST and total bilirubin, before starting, since liver injury has occurred in some patients.

When to Call Your Doctor: Go to an emergency department at once for fever with rash, swollen glands, fainting, prolonged strong palpitations, yellowing of eyes or skin, or any thought of self harm. Do not wait for the next appointment.

Interactions, Pregnancy and Other Precautions

Cenobamate changes how the liver handles several other medicines. Hormonal birth control pills may fail while you take it, so add a reliable non hormonal method. Levels of phenytoin, phenobarbital and clobazam can rise, while lamotrigine and carbamazepine can fall, so your doctor may retune doses across the whole prescription. Carry a list of your medicines and supplements to every visit.

Pregnancy needs a careful talk in advance. Animal studies point to possible harm to the baby and human data is limited, so the call is made person by person with the neurologist and, where possible, the obstetric team. Breastfeeding safety is not established either. In kidney disease, doses may need reduction, and use is not recommended for people with end stage kidney disease on dialysis.

Patient Reminder: Never stop cenobamate suddenly. Rapid withdrawal of any seizure medicine can trigger more seizures or status epilepticus, a long seizure that is a medical emergency. Reduce only through a gradual, doctor guided taper.

Cenobamate Price in India and How to Get It

Until now, cenobamate reached Indian patients only as imported Xcopri or Ontozry packs, a slow and paperwork heavy route. Domestic manufacture opens the way to regular pharmacy supply, and the real cost picture will be clear only when the company announces the MRP.

As of 17 August 2026, the company has not officially disclosed the Indian brand name or the MRP. Any rupee figure you see online today refers to old import era pricing, not the Indian product. This page will be updated the day launch details arrive. Cenobamate tablets will stay prescription only, and the sensible route is through a neurologist. [Normal Blood Sugar Chart]

QuestionPosition as of 17 August 2026
Approved in IndiaYes, DCGI approval to Bajaj Healthcare, August 2026
Indian brand nameNot announced yet
MRP in IndiaNot announced yet
Earlier availabilityImport of foreign brands Xcopri and Ontozry only
Prescription statusPrescription only, ideally through a neurologist

Key Takeaways

  • Ask your neurologist whether cenobamate fits your seizure type before changing any treatment.
  • Start a written seizure diary today, it gives your doctor a fair baseline for any new medicine.
  • If you begin cenobamate, respect the two week step plan and report fever or rash the same day.
  • Women on birth control pills should settle a backup non hormonal method with their doctor.
  • Watch for the official launch announcement for the Indian brand name and MRP.

Frequently Asked Questions

What is cenobamate used for?

Cenobamate treats partial onset seizures, also called focal seizures, in adults. It can be prescribed alone or alongside other seizure medicines, and it is mainly considered when seizures continue despite standard treatment.

Is cenobamate available in India now?

DCGI approved Bajaj Healthcare in August 2026 to manufacture and market cenobamate tablets in India, the first such approval in the country. The commercial launch is expected soon, so pharmacy availability will follow the company’s launch announcement.

What is the price of cenobamate tablets in India?

Bajaj Healthcare has not disclosed the Indian MRP yet. Prices quoted online today reflect old import era costs for foreign brands, not the Indian product. Domestic manufacture usually brings a large price drop, and this page will be updated once the official MRP is out.

What is the brand name of cenobamate in India?

The Indian brand name has not been announced. Globally the medicine is sold as Xcopri in the United States and Ontozry in Europe. Bajaj Healthcare will reveal its Indian brand name at launch.

How is cenobamate different from other epilepsy medicines?

Most older medicines act on one brain pathway. Cenobamate works on two, calming sodium channels while supporting GABA, the brain’s natural calming signal. In trials, this dual action produced higher complete seizure freedom rates than placebo in hard to treat focal epilepsy.

What are the common side effects of cenobamate tablets?

Sleepiness, dizziness, tiredness, headache, nausea and double vision are the most reported effects, and they are usually dose related. Rare but serious risks include the DRESS allergic reaction, QT interval shortening and mood changes, which need urgent medical attention.

Can cenobamate be taken during pregnancy?

Pregnancy use is an individual risk and benefit decision taken with your neurologist and obstetric doctor, because animal studies suggest possible harm to the baby and human data is limited. It can also make hormonal birth control less effective, so contraception planning matters before starting.

Does cenobamate cure epilepsy permanently?

No seizure medicine cures epilepsy. Cenobamate controls seizures while it is taken, and in trials about one in five people on the higher dose became seizure free during the maintenance phase. Stopping it suddenly is dangerous and any change needs a doctor guided plan.


Medically reviewed by: 

This guide was checked for medical accuracy by our review board before publishing.

Dr. Praveen Verma, MBBS, MD (Pathology), Pathologist and Clinical Laboratory Specialist.
Dr. Himanshu Morya, MBBS, Medical Educator.

Written by: 

Iraphan Khan, BSN, RN, D.Pharm is the founder of RealMedVision and a Public Health Researcher who creates evidence-based health content from trusted medical sources.

Disclaimer:

This article is for education only and does not replace the advice of your own doctor. Always follow what your doctor tells you about your seizure treatment.

References

  1. Bajaj Healthcare secures SEC recommendation for cenobamate tablets, Business Standard, June 2026
  2. Bajaj Healthcare announces DCGI approval to launch cenobamate in India, ScanX report of company announcement, August 2026
  3. Xcopri (cenobamate tablets) current prescribing information, DailyMed, US National Library of Medicine
  4. Cenobamate, MedlinePlus drug information, US National Library of Medicine
  5. Krauss GL et al. Safety and efficacy of adjunctive cenobamate in uncontrolled focal seizures, Lancet Neurology, 2020
  6. Chung SS et al. Randomized phase 2 study of adjunctive cenobamate, Neurology, 2020
  7. Epilepsy fact sheet, World Health Organization
  8. Addressing the burden of epilepsy in India, Neurology India, 2017



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