Last reviewed 2026-05-14 · How we verify

GUAIMESAL

Phase 2 active Small molecule

GUAIMESAL is a guaimesal drug. It is currently in Phase 2 development.

GUAIMESAL is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.

GUAIMESAL is a small molecule drug in the guaimesal class, but information on its target, approved indications, and commercial status is limited. Its mechanism of action and pharmacokinetic properties are also unknown. As a result, it is difficult to provide a comprehensive summary of GUAIMESAL's characteristics and clinical use. Further research is needed to determine its potential therapeutic applications and safety profile. Currently, there is limited information available on GUAIMESAL.

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	GUAIMESAL
Drug class	guaimesal
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and GUAIMESAL is a key that fits into one of those locks. When it binds to the lock, it triggers a series of events that help to treat a particular condition. This is a simplified explanation of how GUAIMESAL works at a molecular level.

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:

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

Frequently asked questions about GUAIMESAL

What is GUAIMESAL?

GUAIMESAL is a guaimesal drug.

How does GUAIMESAL work?

GUAIMESAL is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.

What drug class is GUAIMESAL in?

GUAIMESAL belongs to the guaimesal class. See all guaimesal drugs at /class/guaimesal.

What development phase is GUAIMESAL in?

GUAIMESAL is in Phase 2.

Drug class: All guaimesal drugs
Therapeutic area: All drugs in Other

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