Originally Published: August 17, 2026 • Last Updated: October 9, 2026
What cenobamate tablets treat, the blood test that comes first, and where the launch stands.
If focal seizures keep breaking through two or three medicines, the list of things left to try can feel short. It is usually longer than it looks, and cenobamate is one of the newer options.
India approved it in August 2026, but cenobamate tablets are not on pharmacy shelves yet.
Quick Answer
- A prescription medicine for focal seizures, also called partial onset seizures, in adults.
- Bajaj Healthcare told the BSE on 12 August 2026 it had DCGI approval for cenobamate tablets in six strengths, 12.5 mg to 200 mg.
- The dose starts at 12.5 mg and rises once every two weeks. That is a safety rule, not a formality.
- As of 9 October 2026, the brand name, MRP and launch date remain unannounced.
Where the Indian Approval Stands
Approval came in two steps. On 26 June 2026 Bajaj Healthcare said the CDSCO Subject Expert Committee for Neurology and Psychiatry had reviewed its Phase 3 report and recommended permission to market. DCGI approval followed on 12 August 2026.
That Indian study is unpublished and the Indian prescribing information is not out, so every figure below comes from the United States label.
A reported company target of Q2 FY27, July to September, has closed with no launch announcement.
How Cenobamate Works
Seizures happen when brain cells fire in a fast, uncontrolled burst. Cenobamate works on that burst from two directions. It damps sodium currents, the gates that let cells fire repeatedly, and strengthens GABA, the brain’s calming signal.
Whether that second pathway explains the seizure freedom figures is still open. The label calls the precise mechanism unknown.
Who Cenobamate Is For
The approved use is focal seizures in adults. The United States label covers cenobamate tablets alone or with other seizure medicines, while the European label is add on only. India’s position will be clear once the local product information appears.
Safety in children is not established. Two groups must not take it at all: anyone allergic to cenobamate or its ingredients, and anyone with familial short QT syndrome, a rare inherited heart rhythm condition. Other heart problems are not a bar, but tell your doctor.
| Extra care if you have | Why |
|---|---|
| Liver disease | Maximum 200 mg daily if mild or moderate, not recommended if severe. |
| Kidney disease | A lower dose may be needed.Not recommended on dialysis |
| Age over 65 | Too few older patients in trials to judge, so dosing stays cautious. |
| Low mood history | Every antiseizure medicine carries this warning for low mood and self harm thoughts.Class wide estimate, about 1 in 500, not a cenobamate rate |
The Blood Test Your Doctor Runs First
This part of the label changed in August 2025, so older write ups miss it. Before the first dose your doctor should check ALT, AST and total bilirubin, unless results from the past three months are available. See our liver function test guide.
The reason is serious. Liver injury has been reported since the medicine went on sale, including acute liver failure needing a transplant. Your doctor may repeat the tests later if symptoms or examination findings point that way.
Tell your doctor promptly if you get unexplained nausea or vomiting, pain under the right ribs, loss of appetite, unusual tiredness, dark urine, or yellow skin or eyes. If tests confirm liver injury and nothing else explains it, treatment is paused or stopped.
Strengths and the Start Low, Go Slow Rule
Six strengths of cenobamate tablets are approved in India. The schedule below is from the United States label and the Indian version may differ.
| Strength | Week in the example schedule |
|---|---|
| 12.5 mg | Weeks 1 and 2Starting dose |
| 25 mg | Weeks 3 and 4First step up |
| 50 mg | Weeks 5 and 6Second step up |
| 100 mg | Weeks 7 and 8Third step up |
| 150 mg | Weeks 9 and 10Fourth step up |
| 200 mg | Week 11 onwardsUsual maintenance dose |
United States prescribing information, checked 9 October 2026. Taken once daily, with or without food, whole or crushed into water. Some go above 200 mg in 50 mg steps to a maximum of 400 mg, depending on seizure control and tolerability.
Why the Dose Rises Only Every Two Weeks
Early on, when the dose was pushed up weekly or faster, a rare but dangerous reaction called DRESS appeared, short for drug reaction with eosinophilia and systemic symptoms. One case was fatal. In a later study of 1,339 patients started at 12.5 mg with two week steps, no DRESS cases turned up, though the label says that does not prove a slower schedule prevents it.
Fever or swollen glands can arrive before any rash, so do not wait for one.
How Well It Works
Two placebo controlled trials support it, both as an add on in adults whose seizures had resisted other medicines. In the dose comparison study in Lancet Neurology, 21 in 100 on 400 mg had zero seizures over a 12 week maintenance phase, against 11 in 100 at 200 mg and 1 in 100 on placebo.
A smaller phase 2 study in Neurology reported 28 in 100 seizure free at 200 mg against 9 in 100. Read that carefully: its maintenance phase ran six weeks, half as long, and seizure freedom came from a later analysis. Both trials also started patients at 50 mg, four times today’s start. The slower schedule used now exists for safety, not better numbers.
A 32 year old man still has four focal seizures a month on two medicines at full doses. If supply arrives, his neurologist might weigh an add on: baseline liver tests, then the lowest strength, reviewed fortnightly.
Composite example, not a specific patient.
Side Effects
Most reported effects hit the nervous system and climb steeply with dose.
| Side effect | Reported in trials |
|---|---|
| Sleepiness | 22 in 100 at 200 mg, 37 in 100 at 400 mg11 in 100 on placebo |
| Dizziness | 22 in 100 at 200 mg, 33 in 100 at 400 mg15 in 100 on placebo |
| Tiredness | 14 in 100 at 200 mg, 24 in 100 at 400 mg7 in 100 on placebo |
| Double vision | 7 in 100 at 200 mg, 15 in 100 at 400 mg2 in 100 on placebo |
| Memory and focus | 6 in 100 at 200 mg, 9 in 100 at 400 mg2 in 100 on placebo |
Pooled trial data from the United States prescribing information, checked 9 October 2026. These are rates in trial participants, not a prediction for you.
Headache and nausea came up too, but close to placebo rates. The dose effect shows in who quits: 9 in 100 stopped at 200 mg against 21 in 100 at 400 mg, and 4 in 100 on placebo. Skip driving until you know how it affects you, and alcohol adds to the drowsiness.
- Fever, rash, swollen glands, or swelling of the face, lips or tongue
- Trouble breathing or swallowing, mouth sores, or unusual bruising
- Fainting, or a fast heartbeat that will not settle
- Any thought of self harm. In India, Tele MANAS is on 14416 at any hour.
QT shortening is usually silent and shows on an ECG rather than as a symptom. Palpitations that drag on, or a blackout, are the exceptions.
Interactions, Pregnancy and Stopping
Cenobamate changes how the liver handles many drugs, so expect your whole prescription to be reviewed. Phenytoin, phenobarbital and clobazam levels can rise, while lamotrigine and carbamazepine can fall. Outside epilepsy, medicines such as omeprazole build up and others clear faster. Valproate, levetiracetam and lacosamide showed no meaningful change.
Raise hormonal birth control before you start, since it can become less reliable and a non hormonal backup is advised. Pregnancy needs planning ahead, because animal studies point to possible harm and human data is thin. Breastfeeding safety is not established. In the United States the drug is a controlled substance that can cause dependence, and its Indian classification is not published.
If you become pregnant, do not stop on your own. Call your neurologist so treatment can be reviewed. Stopping any seizure medicine suddenly can trigger status epilepticus, a prolonged seizure that is an emergency. Tapering runs over at least two weeks.
Price and How to Get It in India
No Indian MRP or confirmed launch date is available in the information cited here. Prices listed for imported brands may not reflect the price of the Indian product if it launches. Check the latest company announcement and confirm availability with a licensed pharmacy.
Key Takeaways
- Start a seizure diary now. It gives your neurologist a baseline before any new medicine.
- Ask whether your liver blood tests are current, since treatment should not start without them.
- If you use hormonal contraception, settle a backup method before the first tablet.
- A price listed for an imported brand may not match the Indian price for cenobamate tablets.
Frequently Asked Questions
What are cenobamate tablets used for?
They treat focal seizures in adults, usually when seizures continue despite standard treatment.
Is cenobamate available in India now?
Not confirmed. Bajaj Healthcare announced DCGI approval in August 2026, but as of 9 October 2026 there is no launch date or confirmed stock.
What is the price of cenobamate tablets in India?
There is no Indian MRP or confirmed launch date yet. Prices listed for imported brands may not reflect the price of the Indian product if it launches, so check the latest company announcement.
What is the brand name of cenobamate in India?
Not announced yet. Globally it is sold as Xcopri in the United States and Ontozry in Europe.
Does cenobamate need blood tests before starting?
Yes. The label asks for ALT, AST and total bilirubin before the first dose, unless those results are under three months old, because liver injury has been reported.
What are the common side effects?
Sleepiness, dizziness, tiredness, double vision and memory trouble lead the list, and all rise with dose. Rarer serious risks include DRESS, liver injury, QT shortening and mood changes.
Can cenobamate be taken during pregnancy?
That is decided with your neurologist, since animal studies suggest possible harm and human data is limited. If you become pregnant, do not stop on your own.
Does cenobamate cure epilepsy?
No seizure medicine cures epilepsy. It controls seizures while taken, and about 21 in 100 on the highest trial dose became seizure free during maintenance.
References
- DailyMed. XCOPRI (cenobamate) prescribing information, August 2025. dailymed.nlm.nih.gov
- Bajaj Healthcare Limited. DCGI approval for cenobamate, BSE filing BHL/STEX 28/2026-27, 12 August 2026. bseindia.com
- Chung SS, French JA, et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020, 94(22), e2311 to e2322. neurology.org
- Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures, a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurology. 2020, 19(1), 38 to 48. doi.org
All sources checked 9 October 2026. The Indian prescribing information was not public.
Iraphan Khan, BSN, RN, D.Pharm, Public Health Researcher. Founder of RealMedVision, writing from prescribing information, regulatory filings and published trials.
Dr Praveen Verma, MBBS, MD (Pathology)
Dr Himanshu Morya, MBBS, Medical Educator
Reviewed 9 October 2026 against the current label and Indian regulatory position.
Cenobamate tablets are prescription only. No dose here is a recommendation for you. Follow what your own doctor tells you, and never start or stop a seizure medicine alone.