Last reviewed 2026-04-19 · How we verify

CLOBENZEPAM

Phase 2 active Small molecule

CLOBENZEPAM is a clobenzepam drug. It is currently in Phase 2 development.

Clobenzepam is thought to work by interacting with the brain's GABA receptors to produce a calming effect.

Clobenzepam is a small molecule drug in the clobenzepam class, but its target and exact mechanism of action are unknown. It is not FDA-approved for any indications. The commercial status of clobenzepam is unclear, and it may be patented or available as a generic. Key safety considerations are not well-documented. Further research is needed to understand its pharmacology and potential therapeutic applications.

Likelihood of approval

12.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	CLOBENZEPAM
Drug class	clobenzepam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city, with lots of signals and activity going on. GABA receptors are like traffic cops that help slow down the traffic and keep things calm. Clobenzepam is believed to help these traffic cops work more effectively, leading to a calming effect on the brain.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

CLOBENZEPAM CI brief — competitive landscape report
CLOBENZEPAM updates RSS · CI watch RSS

Frequently asked questions about CLOBENZEPAM

What is CLOBENZEPAM?

CLOBENZEPAM is a clobenzepam drug.

How does CLOBENZEPAM work?

Clobenzepam is thought to work by interacting with the brain's GABA receptors to produce a calming effect.

What drug class is CLOBENZEPAM in?

CLOBENZEPAM belongs to the clobenzepam class. See all clobenzepam drugs at /class/clobenzepam.

What development phase is CLOBENZEPAM in?

CLOBENZEPAM is in Phase 2.

Drug class: All clobenzepam drugs
Therapeutic area: All drugs in Neuroscience

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