Last reviewed 2026-05-27 · How we verify

Hializan (OXAZOLAM)

Phase 2 active Small molecule ✓ Verified May 2026

Hializan (generic name: OXAZOLAM) is a oxazolam drug. It is currently in Phase 2 development.

Oxazolam is thought to work by enhancing the activity of neurotransmitters in the brain that help regulate anxiety and sleep.

Hializan is a small molecule with synonyms including HIALIZAN, OXAZOLAM, SERENAL, and TRANQUIT.

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	OXAZOLAM
Drug class	oxazolam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a city with many different neighborhoods, each with its own unique function. Oxazolam is like a special key that unlocks the doors to certain neighborhoods, allowing the right chemicals to flow in and help calm the city down. This can lead to feelings of relaxation and reduced anxiety.

Approved indications

No approved indications tracked.

Common side effects

Myopathy

Competitive intelligence

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

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

Frequently asked questions about Hializan

What is Hializan?

Hializan (OXAZOLAM) is a oxazolam drug.

How does Hializan work?

Oxazolam is thought to work by enhancing the activity of neurotransmitters in the brain that help regulate anxiety and sleep.

What is the generic name of Hializan?

OXAZOLAM is the generic (nonproprietary) name of Hializan.

What drug class is Hializan in?

Hializan belongs to the oxazolam class. See all oxazolam drugs at /class/oxazolam.

What development phase is Hializan in?

Hializan is in Phase 2.

What are the side effects of Hializan?

Common side effects of Hializan include Myopathy.

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

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