Last reviewed 2026-05-30 · How we verify

DILAZEP

Phase 2 active Small molecule ✓ Verified May 2026 Quality 31/100

DILAZEP is a dilazep drug. It is currently in Phase 2 development.

DILAZEP works by blocking the ENT1 transporter, which regulates the flow of certain molecules into cells.

DILAZEP is a small molecule. Its exact mechanism and indications are not specified in the provided facts.

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	DILAZEP
Drug class	dilazep
Target	Equilibrative nucleoside transporter 1, Sodium channel alpha subunits; brain (Types I, II, III), Equilibrative nucleoside transporter 2
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of the ENT1 transporter like a gate that controls what enters a cell. When DILAZEP blocks this gate, it can affect the levels of certain molecules inside the cell. This can have various effects on the body, depending on the specific molecules involved and the cells affected.

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:

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

Frequently asked questions about DILAZEP

What is DILAZEP?

DILAZEP is a dilazep drug.

How does DILAZEP work?

DILAZEP works by blocking the ENT1 transporter, which regulates the flow of certain molecules into cells.

What drug class is DILAZEP in?

DILAZEP belongs to the dilazep class. See all dilazep drugs at /class/dilazep.

What development phase is DILAZEP in?

DILAZEP is in Phase 2.

What does DILAZEP target?

DILAZEP targets Equilibrative nucleoside transporter 1, Sodium channel alpha subunits; brain (Types I, II, III), Equilibrative nucleoside transporter 2 and is a dilazep.

Drug class: All dilazep drugs
Target: All drugs targeting Equilibrative nucleoside transporter 1, Sodium channel alpha subunits; brain (Types I, II, III), Equilibrative nucleoside transporter 2
Therapeutic area: All drugs in Other

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