Last reviewed 2026-04-20 · How we verify

Hydroxyguanabenz (GUANOXABENZ)

Phase 2 active Small molecule

Hydroxyguanabenz (generic name: GUANOXABENZ) is a guanoxabenz drug. It is currently in Phase 2 development.

Hydroxyguanabenz is believed to work by modulating certain neurotransmitter systems in the brain.

Hydroxyguanabenz, also known as GUANOXABENZ, is a small molecule drug in the guanoxabenz class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating certain neurotransmitter systems in the brain. Hydroxyguanabenz is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. Further research is needed to fully understand its potential therapeutic applications and safety profile. As a result, it is not currently available for clinical use.

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	GUANOXABENZ
Drug class	guanoxabenz
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of neurotransmitters like messengers that help different parts of the brain talk to each other. Hydroxyguanabenz is thought to help regulate the activity of these messengers, which can help to calm or stimulate different brain regions as needed. This can potentially help to treat a range of conditions, but more research is needed to understand its exact effects.

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:

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

Frequently asked questions about Hydroxyguanabenz

What is Hydroxyguanabenz?

Hydroxyguanabenz (GUANOXABENZ) is a guanoxabenz drug.

How does Hydroxyguanabenz work?

Hydroxyguanabenz is believed to work by modulating certain neurotransmitter systems in the brain.

What is the generic name of Hydroxyguanabenz?

GUANOXABENZ is the generic (nonproprietary) name of Hydroxyguanabenz.

What drug class is Hydroxyguanabenz in?

Hydroxyguanabenz belongs to the guanoxabenz class. See all guanoxabenz drugs at /class/guanoxabenz.

What development phase is Hydroxyguanabenz in?

Hydroxyguanabenz is in Phase 2.

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

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