Last reviewed 2026-04-20 · How we verify

Doxans (DOXEFAZEPAM)

Phase 2 active Small molecule

Doxans (generic name: DOXEFAZEPAM) is a doxefazepam drug. It is currently in Phase 2 development for Insomnia.

Doxefazepam works by enhancing the activity of a neurotransmitter called GABA, which helps to calm the brain and induce sleep.

Doxefazepam, also known as DOXEFAZEPAM, is a small molecule belonging to the drug class of doxefazepam. It is used to treat insomnia, but its target is currently unknown. The commercial status of doxefazepam is unclear, and it is not known if it is patented or available as a generic medication. Further information on its pharmacokinetics, such as half-life and bioavailability, is also unavailable. Doxefazepam's approval status and indications are limited to insomnia.

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	DOXEFAZEPAM
Drug class	doxefazepam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city with lots of noise and activity. GABA is like a traffic cop that helps to slow down the traffic and calm things down. Doxefazepam helps GABA do its job more effectively, making it easier to fall asleep and stay asleep.

Approved indications

Insomnia

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:

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

Frequently asked questions about Doxans

What is Doxans?

Doxans (DOXEFAZEPAM) is a doxefazepam drug, indicated for Insomnia.

How does Doxans work?

Doxefazepam works by enhancing the activity of a neurotransmitter called GABA, which helps to calm the brain and induce sleep.

What is Doxans used for?

Doxans is indicated for Insomnia.

What is the generic name of Doxans?

DOXEFAZEPAM is the generic (nonproprietary) name of Doxans.

What drug class is Doxans in?

Doxans belongs to the doxefazepam class. See all doxefazepam drugs at /class/doxefazepam.

What development phase is Doxans in?

Doxans is in Phase 2.

Drug class: All doxefazepam drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Insomnia

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