Last reviewed 2026-04-19 · How we verify

EPRAZINONE

Phase 2 active Small molecule

EPRAZINONE is a eprazinone drug. It is currently in Phase 2 development.

Eprazinone is a small molecule that works by interacting with a specific target in the body, but its exact mechanism is unknown.

Eprazinone is a small molecule drug of the eprazinone class, but its target and mechanism of action are unknown. It is not clear if it has been approved by the FDA or if it is commercially available. Eprazinone's indications, half-life, bioavailability, and generic manufacturers are also unknown. As a result, its commercial status and key safety considerations cannot be determined. Further research is needed to understand this drug's properties and potential uses.

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	EPRAZINONE
Drug class	eprazinone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and eprazinone is a key that fits into one of those locks. When it binds to the lock, it can either turn it on or off, depending on the type of lock and the key's shape. However, since eprazinone's target is unknown, we can't say exactly how it works or what it does.

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:

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

Frequently asked questions about EPRAZINONE

What is EPRAZINONE?

EPRAZINONE is a eprazinone drug.

How does EPRAZINONE work?

Eprazinone is a small molecule that works by interacting with a specific target in the body, but its exact mechanism is unknown.

What drug class is EPRAZINONE in?

EPRAZINONE belongs to the eprazinone class. See all eprazinone drugs at /class/eprazinone.

What development phase is EPRAZINONE in?

EPRAZINONE is in Phase 2.

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

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