Last reviewed 2026-05-26 · How we verify

Metazepium Iodide (BUZEPIDE METIODIDE)

Phase 2 active Small molecule ✓ Verified May 2026

Metazepium Iodide (generic name: BUZEPIDE METIODIDE) is a drug. It is currently in Phase 2 development.

Metazepine iodide is thought to work by interacting with specific biological pathways, but the exact mechanism is unknown.

Metazepine iodide is a small molecule with synonyms including Buzepide methiodide, Diphehexamide methiodide, and F.I. 6146.

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	BUZEPIDE METIODIDE
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a complex network of roads and intersections. Metazepine iodide is like a traffic controller that tries to regulate the flow of information between different parts of the brain. However, since its exact mechanism is unknown, it's like trying to navigate a road system without a map.

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:

Metazepium Iodide CI brief — competitive landscape report
Metazepium Iodide updates RSS · CI watch RSS

Frequently asked questions about Metazepium Iodide

What is Metazepium Iodide?

Metazepium Iodide (BUZEPIDE METIODIDE) is a Small molecule drug.

How does Metazepium Iodide work?

Metazepine iodide is thought to work by interacting with specific biological pathways, but the exact mechanism is unknown.

What is the generic name of Metazepium Iodide?

BUZEPIDE METIODIDE is the generic (nonproprietary) name of Metazepium Iodide.

What development phase is Metazepium Iodide in?

Metazepium Iodide is in Phase 2.

Therapeutic area: All drugs in Neuroscience

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