Last reviewed 2026-05-18 · How we verify

Benazolin (METIZOLINE)

Phase 2 active Small molecule

Benazolin (generic name: METIZOLINE) is a metizoline drug. It is currently in Phase 2 development for Nasal congestion.

Benazolin works by blocking the action of histamine and other substances that cause nasal congestion.

Benazolin, also known as Metizoline, is a small molecule drug that targets Nischarin. It belongs to the metizoline class and is used to treat nasal congestion. The commercial status of Benazolin is currently unknown, and it is not FDA-approved. As a result, there is limited information available on its safety profile and pharmacokinetic properties. Further research is needed to fully understand the characteristics of Benazolin.

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	METIZOLINE
Drug class	metizoline
Target	Nischarin
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Imagine your nose has tiny blood vessels that swell up when you're congested. Benazolin helps to reduce this swelling by blocking the signals that tell these blood vessels to get bigger. This makes it easier to breathe through your nose.

Approved indications

Nasal congestion

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:

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

Frequently asked questions about Benazolin

What is Benazolin?

Benazolin (METIZOLINE) is a metizoline drug, indicated for Nasal congestion.

How does Benazolin work?

Benazolin works by blocking the action of histamine and other substances that cause nasal congestion.

What is Benazolin used for?

Benazolin is indicated for Nasal congestion.

What is the generic name of Benazolin?

METIZOLINE is the generic (nonproprietary) name of Benazolin.

What drug class is Benazolin in?

Benazolin belongs to the metizoline class. See all metizoline drugs at /class/metizoline.

What development phase is Benazolin in?

Benazolin is in Phase 2.

What does Benazolin target?

Benazolin targets Nischarin and is a metizoline.

Drug class: All metizoline drugs
Target: All drugs targeting Nischarin
Therapeutic area: All drugs in Hematology
Indication: Drugs for Nasal congestion

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