Last reviewed 2026-04-20 · How we verify

Diphacine (DIPHENADIONE)

Phase 2 active Small molecule

Diphacine (generic name: DIPHENADIONE) is a diphenadione drug. It is currently in Phase 2 development.

Diphacine works by inhibiting the activity of vitamin K-dependent clotting factors in the blood.

Diphacine, also known as DIPHENADIONE, is a small molecule drug in the diphenadione class. Its exact target is unknown, but it is used to treat certain conditions. Unfortunately, there is limited information available on its commercial status, approved indications, and pharmacokinetic properties. Further research is needed to fully understand this medication. As a result, it is difficult to provide a comprehensive summary of Diphacine.

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	DIPHENADIONE
Drug class	diphenadione
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Think of it like a brake on your car's brakes. Diphacine helps slow down the process of blood clotting, which can be beneficial for people who are at risk of forming too many clots. This is especially important for people who have conditions like atrial fibrillation or have had a heart attack.

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:

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

Frequently asked questions about Diphacine

What is Diphacine?

Diphacine (DIPHENADIONE) is a diphenadione drug.

How does Diphacine work?

Diphacine works by inhibiting the activity of vitamin K-dependent clotting factors in the blood.

What is the generic name of Diphacine?

DIPHENADIONE is the generic (nonproprietary) name of Diphacine.

What drug class is Diphacine in?

Diphacine belongs to the diphenadione class. See all diphenadione drugs at /class/diphenadione.

What development phase is Diphacine in?

Diphacine is in Phase 2.

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

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