Last reviewed 2026-04-20 · How we verify

M.G. 13054 (FENQUIZONE)

Phase 2 active Small molecule

M.G. 13054 (generic name: FENQUIZONE) is a fenquizone drug. It is currently in Phase 2 development.

Fenquizone is thought to work by inhibiting a specific enzyme or pathway, although the exact mechanism is unclear.

Fenquizone, also known as M.G. 13054, is a small molecule drug in the fenquizone class. Its original development is attributed to an unknown entity, and its current ownership is also unclear. The target of fenquizone is unknown, and it has not been approved by the FDA for any indications. The commercial status of fenquizone, including whether it is patented or generic, is also unknown. As a result, there is limited information available on its key safety considerations, half-life, bioavailability, and generic manufacturers.

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	FENQUIZONE
Drug class	fenquizone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a factory, and enzymes are the workers that help make things happen. Fenquizone is like a tool that tries to stop one of these workers from doing their job, which can affect how the factory runs. However, the exact way it works is still not well understood.

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:

M.G. 13054 CI brief — competitive landscape report
M.G. 13054 updates RSS · CI watch RSS

Frequently asked questions about M.G. 13054

What is M.G. 13054?

M.G. 13054 (FENQUIZONE) is a fenquizone drug.

How does M.G. 13054 work?

Fenquizone is thought to work by inhibiting a specific enzyme or pathway, although the exact mechanism is unclear.

What is the generic name of M.G. 13054?

FENQUIZONE is the generic (nonproprietary) name of M.G. 13054.

What drug class is M.G. 13054 in?

M.G. 13054 belongs to the fenquizone class. See all fenquizone drugs at /class/fenquizone.

What development phase is M.G. 13054 in?

M.G. 13054 is in Phase 2.

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

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