Last reviewed 2026-04-20 · How we verify

Guaiaspir (GUACETISAL)

Phase 2 active Small molecule

Guaiaspir (generic name: GUACETISAL) is a guacetisal drug. It is currently in Phase 2 development.

Guaiaspir works by inhibiting the enzyme cyclooxygenase (COX), which is responsible for producing prostaglandins.

Guaiaspir, also known as Guacetisal, is a small molecule drug in the guacetisal class. It is a non-steroidal anti-inflammatory drug (NSAID) that works by inhibiting the production of prostaglandins, which are hormone-like substances that cause pain and inflammation. Guaiaspir is used to treat various conditions, but its specific indications are unknown. The commercial status of Guaiaspir is unclear, and it may be patented or available as a generic medication. As a pharmaceutical professional, it is essential to consult the latest information on Guaiaspir's safety profile and efficacy.

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	GUACETISAL
Drug class	guacetisal
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has a messaging system that sends signals to cause pain and inflammation. Guaiaspir blocks the production of these pain-causing messages by inhibiting the COX enzyme, which helps to reduce pain and 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:

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

Frequently asked questions about Guaiaspir

What is Guaiaspir?

Guaiaspir (GUACETISAL) is a guacetisal drug.

How does Guaiaspir work?

Guaiaspir works by inhibiting the enzyme cyclooxygenase (COX), which is responsible for producing prostaglandins.

What is the generic name of Guaiaspir?

GUACETISAL is the generic (nonproprietary) name of Guaiaspir.

What drug class is Guaiaspir in?

Guaiaspir belongs to the guacetisal class. See all guacetisal drugs at /class/guacetisal.

What development phase is Guaiaspir in?

Guaiaspir is in Phase 2.

Drug class: All guacetisal drugs
Therapeutic area: All drugs in Pain

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