Last reviewed 2026-04-19 · How we verify

Dicumarols

Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 2 active Small molecule

Dicumarols is a Small molecule drug developed by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. It is currently in Phase 2 development.

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	Dicumarols
Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Mild Head Injury, Antiplatelets, and Anticoagulants

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Dicumarols CI brief — competitive landscape report
Dicumarols updates RSS · CI watch RSS
Fondazione Policlinico Universitario Agostino Gemelli IRCCS portfolio CI

Frequently asked questions about Dicumarols

What is Dicumarols?

Dicumarols is a Small molecule drug developed by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who makes Dicumarols?

Dicumarols is developed by Fondazione Policlinico Universitario Agostino Gemelli IRCCS (see full Fondazione Policlinico Universitario Agostino Gemelli IRCCS pipeline at /company/fondazione-policlinico-universitario-agostino-gemelli-irccs).

What development phase is Dicumarols in?

Dicumarols is in Phase 2.

Manufacturer: Fondazione Policlinico Universitario Agostino Gemelli IRCCS — full pipeline
Therapeutic area: All drugs in Other

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