Last reviewed 2026-04-22 · How we verify

Clobazam High Dose

Lundbeck LLC · Phase 3 active Small molecule

Clobazam High Dose is a Benzodiazepine Small molecule drug developed by Lundbeck LLC. It is currently in Phase 3 development for Seizure disorders / Epilepsy (treatment-resistant or adjunctive therapy). 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 Seizure disorders / Epilepsy (treatment-resistant or adjunctive therapy).

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

Mechanism of action

Clobazam binds to GABA-A receptors and potentiates the effect of the inhibitory neurotransmitter GABA, increasing chloride channel conductance and neuronal hyperpolarization. This results in reduced neuronal excitability and seizure threshold elevation. The high-dose formulation is being investigated to optimize efficacy in treatment-resistant seizure disorders.

Approved indications

Seizure disorders / Epilepsy (treatment-resistant or adjunctive therapy)

Common side effects

Somnolence
Ataxia
Dizziness
Fatigue
Behavioral changes

Key clinical trials

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 High Dose CI brief — competitive landscape report
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Lundbeck LLC portfolio CI

Frequently asked questions about Clobazam High Dose

What is Clobazam High Dose?

Clobazam High Dose is a Benzodiazepine drug developed by Lundbeck LLC, indicated for Seizure disorders / Epilepsy (treatment-resistant or adjunctive therapy).

How does Clobazam High Dose work?

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

What is Clobazam High Dose used for?

Clobazam High Dose is indicated for Seizure disorders / Epilepsy (treatment-resistant or adjunctive therapy).

Who makes Clobazam High Dose?

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

Is Clobazam High Dose also known as anything else?

Clobazam High Dose is also known as Onfi™.

What drug class is Clobazam High Dose in?

Clobazam High Dose belongs to the Benzodiazepine class. See all Benzodiazepine drugs at /class/benzodiazepine.

What development phase is Clobazam High Dose in?

Clobazam High Dose is in Phase 3.

What are the side effects of Clobazam High Dose?

Common side effects of Clobazam High Dose include Somnolence, Ataxia, Dizziness, Fatigue, Behavioral changes.

What does Clobazam High Dose target?

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

Drug class: All Benzodiazepine drugs
Target: All drugs targeting GABA-A receptor
Manufacturer: Lundbeck LLC — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Seizure disorders / Epilepsy (treatment-resistant or adjunctive therapy)
Also known as: Onfi™

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