Last reviewed 2026-05-19 · How we verify

Epoxudine (EDOXUDINE)

Phase 2 active Small molecule ✓ Verified May 2026

Epoxudine (generic name: EDOXUDINE) is a edoxudine drug. It is currently in Phase 2 development.

Edoxudine is thought to work by inhibiting viral replication, although the exact mechanism is unclear.

Epoxudine is a small molecule with the chemical name 5-ethyl-3-(2'-deoxyribosyl)uracil. It is also known by other synonyms, including edoxudina, edoxudine, and edoxudine.

Likelihood of approval

17.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	EDOXUDINE
Drug class	edoxudine
Target	Thymidine kinase
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like factories that make copies of a virus. Edoxudine is like a tool that tries to stop the factory from making more copies of the virus, but it's not entirely clear how it does this. More research is needed to understand how it works.

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:

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

Frequently asked questions about Epoxudine

What is Epoxudine?

Epoxudine (EDOXUDINE) is a edoxudine drug.

How does Epoxudine work?

Edoxudine is thought to work by inhibiting viral replication, although the exact mechanism is unclear.

What is the generic name of Epoxudine?

EDOXUDINE is the generic (nonproprietary) name of Epoxudine.

What drug class is Epoxudine in?

Epoxudine belongs to the edoxudine class. See all edoxudine drugs at /class/edoxudine.

What development phase is Epoxudine in?

Epoxudine is in Phase 2.

What does Epoxudine target?

Epoxudine targets Thymidine kinase and is a edoxudine.

Drug class: All edoxudine drugs
Target: All drugs targeting Thymidine kinase
Therapeutic area: All drugs in Infectious Disease

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