Last reviewed 2026-05-26 · How we verify

Dicumoxan (COUMETAROL)

Phase 2 active Small molecule ✓ Verified May 2026

Dicumoxan (generic name: COUMETAROL) is a coumetarol drug. It is currently in Phase 2 development.

Dicumoxan works by inhibiting vitamin K epoxide reductase, which is involved in blood clotting.

Dicumoxan, also known as Cumetarol, is a small molecule. Its exact mechanism and indications are not specified in the provided information.

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	COUMETAROL
Drug class	coumetarol
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Think of it like a brake on your car's engine. Vitamin K epoxide reductase helps your body make blood clots, which can be useful in some situations, but also cause problems if they form too easily. Dicumoxan puts the brake on this process, helping to prevent excessive blood clotting.

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:

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

Frequently asked questions about Dicumoxan

What is Dicumoxan?

Dicumoxan (COUMETAROL) is a coumetarol drug.

How does Dicumoxan work?

Dicumoxan works by inhibiting vitamin K epoxide reductase, which is involved in blood clotting.

What is the generic name of Dicumoxan?

COUMETAROL is the generic (nonproprietary) name of Dicumoxan.

What drug class is Dicumoxan in?

Dicumoxan belongs to the coumetarol class. See all coumetarol drugs at /class/coumetarol.

What development phase is Dicumoxan in?

Dicumoxan is in Phase 2.

Drug class: All coumetarol drugs
Therapeutic area: All drugs in Hematology

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