Last reviewed 2026-06-01 · How we verify

GUANAZODINE

Phase 2 active Small molecule

GUANAZODINE is a guanazodine drug. It is currently in Phase 2 development.

Guanazodine works by modulating a specific target to produce its therapeutic effects.

Guanazodine is a small molecule drug in the guanazodine class, but specific details about its development, approval status, and commercial status are not available. It is intended to target a specific mechanism, but the exact target is unknown. Guanazodine is not FDA-approved for any indications, and its pharmacokinetic properties, such as half-life and bioavailability, are also unknown. As a result, there is limited information available about its safety profile and potential side effects. Further research is needed to fully understand the properties and potential uses of guanazodine.

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	GUANAZODINE
Drug class	guanazodine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a 'volume control' that regulates how much of a certain signal is sent. Guanazodine helps adjust this volume control to achieve a desired effect, such as reducing pain or inflammation.

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:

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

Frequently asked questions about GUANAZODINE

What is GUANAZODINE?

GUANAZODINE is a guanazodine drug.

How does GUANAZODINE work?

Guanazodine works by modulating a specific target to produce its therapeutic effects.

What drug class is GUANAZODINE in?

GUANAZODINE belongs to the guanazodine class. See all guanazodine drugs at /class/guanazodine.

What development phase is GUANAZODINE in?

GUANAZODINE is in Phase 2.

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

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