Last reviewed 2026-04-22 · How we verify

Clobazam Low Dose

Lundbeck LLC · Phase 3 active Small molecule

Clobazam Low Dose is a Benzodiazepine anticonvulsant Small molecule drug developed by Lundbeck LLC. It is currently in Phase 3 development for Adjunctive treatment of seizures in epilepsy, Lennox-Gastaut syndrome. Also known as: Onfi™.

Clobazam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system to reduce seizure activity.

Clobazam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system to reduce seizure activity. Used for Adjunctive treatment of seizures in epilepsy, Lennox-Gastaut syndrome.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Clobazam Low Dose
Also known as	Onfi™
Sponsor	Lundbeck LLC
Drug class	Benzodiazepine anticonvulsant
Target	GABA-A receptor
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Clobazam binds to GABA-A receptors on neurons, potentiating the effect of the inhibitory neurotransmitter GABA. This increases chloride ion influx and neuronal hyperpolarization, raising the seizure threshold and reducing abnormal electrical activity in the brain. The low-dose formulation is designed to optimize efficacy while minimizing sedation and dependence risk.

Approved indications

Adjunctive treatment of seizures in epilepsy
Lennox-Gastaut syndrome

Common side effects

Sedation
Ataxia
Dizziness
Fatigue
Behavioral changes

Key clinical trials

Clobazam in Patients With Lennox-Gastaut Syndrome (PHASE3)
Clobazam in Subjects With Lennox-Gastaut Syndrome (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Clobazam Low Dose CI brief — competitive landscape report
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Frequently asked questions about Clobazam Low Dose

What is Clobazam Low Dose?

Clobazam Low Dose is a Benzodiazepine anticonvulsant drug developed by Lundbeck LLC, indicated for Adjunctive treatment of seizures in epilepsy, Lennox-Gastaut syndrome.

How does Clobazam Low Dose work?

Clobazam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system to reduce seizure activity.

What is Clobazam Low Dose used for?

Clobazam Low Dose is indicated for Adjunctive treatment of seizures in epilepsy, Lennox-Gastaut syndrome.

Who makes Clobazam Low Dose?

Clobazam Low Dose is developed by Lundbeck LLC (see full Lundbeck LLC pipeline at /company/lundbeck-llc).

Is Clobazam Low Dose also known as anything else?

Clobazam Low Dose is also known as Onfi™.

What drug class is Clobazam Low Dose in?

Clobazam Low Dose belongs to the Benzodiazepine anticonvulsant class. See all Benzodiazepine anticonvulsant drugs at /class/benzodiazepine-anticonvulsant.

What development phase is Clobazam Low Dose in?

Clobazam Low Dose is in Phase 3.

What are the side effects of Clobazam Low Dose?

Common side effects of Clobazam Low Dose include Sedation, Ataxia, Dizziness, Fatigue, Behavioral changes.

What does Clobazam Low Dose target?

Clobazam Low Dose targets GABA-A receptor and is a Benzodiazepine anticonvulsant.

Drug class: All Benzodiazepine anticonvulsant drugs
Target: All drugs targeting GABA-A receptor
Manufacturer: Lundbeck LLC — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Adjunctive treatment of seizures in epilepsy
Indication: Drugs for Lennox-Gastaut syndrome
Also known as: Onfi™

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing