Last reviewed 2026-05-22 · How we verify

Diazil (BENACTYZINE)

Phase 2 active Small molecule ✓ Verified May 2026

Diazil (generic name: BENACTYZINE) is a benactyzine drug. It is currently in Phase 2 development.

Diazil is thought to work by modulating neurotransmitter activity in the central nervous system.

Diazil is a small molecule. Its exact mechanism of action is not specified in the provided information.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	BENACTYZINE
Drug class	benactyzine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a busy city with many different streets and intersections. Diazil is like a traffic manager that helps regulate the flow of information between different parts of the city, keeping things running smoothly. By doing so, it can help alleviate symptoms of certain conditions.

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:

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

Frequently asked questions about Diazil

What is Diazil?

Diazil (BENACTYZINE) is a benactyzine drug.

How does Diazil work?

Diazil is thought to work by modulating neurotransmitter activity in the central nervous system.

What is the generic name of Diazil?

BENACTYZINE is the generic (nonproprietary) name of Diazil.

What drug class is Diazil in?

Diazil belongs to the benactyzine class. See all benactyzine drugs at /class/benactyzine.

What development phase is Diazil in?

Diazil is in Phase 2.

Drug class: All benactyzine drugs
Therapeutic area: All drugs in Neuroscience

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