Last reviewed 2026-04-20 · How we verify

Cloxazolazepam (CLOXAZOLAM)

Phase 2 active Small molecule

Cloxazolazepam (generic name: CLOXAZOLAM) is a cloxazolam drug. It is currently in Phase 2 development.

Cloxazolazepam works by inhibiting the enzyme Aldo-keto reductase family 1 member C3.

Cloxazolazepam, also known as Cloxazolam, is a small molecule drug that targets the Aldo-keto reductase family 1 member C3. It belongs to the cloxazolam drug class and is not FDA-approved for any indications. The commercial status of Cloxazolazepam is unknown, and it is not clear if it is patented or available as a generic medication. Further research is needed to determine its safety and efficacy. As a result, it is not currently used in clinical practice.

Likelihood of approval

15.3% 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).

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	CLOXAZOLAM
Drug class	cloxazolam
Target	Aldo-keto reductase family 1 member C3
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that unlocks a door. In this case, the key is Cloxazolazepam, and the door is the enzyme Aldo-keto reductase family 1 member C3. By inhibiting this enzyme, Cloxazolazepam can affect the way the body processes certain chemicals, leading to its therapeutic effects.

Approved indications

No approved indications tracked.

Common side effects

Drug dependence
Panic disorder

Competitive intelligence

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

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

Frequently asked questions about Cloxazolazepam

What is Cloxazolazepam?

Cloxazolazepam (CLOXAZOLAM) is a cloxazolam drug.

How does Cloxazolazepam work?

Cloxazolazepam works by inhibiting the enzyme Aldo-keto reductase family 1 member C3.

What is the generic name of Cloxazolazepam?

CLOXAZOLAM is the generic (nonproprietary) name of Cloxazolazepam.

What drug class is Cloxazolazepam in?

Cloxazolazepam belongs to the cloxazolam class. See all cloxazolam drugs at /class/cloxazolam.

What development phase is Cloxazolazepam in?

Cloxazolazepam is in Phase 2.

What are the side effects of Cloxazolazepam?

Common side effects of Cloxazolazepam include Drug dependence, Panic disorder.

What does Cloxazolazepam target?

Cloxazolazepam targets Aldo-keto reductase family 1 member C3 and is a cloxazolam.

Drug class: All cloxazolam drugs
Target: All drugs targeting Aldo-keto reductase family 1 member C3
Therapeutic area: All drugs in Other

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