Last reviewed 2026-05-25 · How we verify

Fazadon (FAZADINIUM)

Phase 2 active Small molecule ✓ Verified May 2026

Fazadon (generic name: FAZADINIUM) is a fazadinium drug. It is currently in Phase 2 development.

Fazadinium works by blocking the action of acetylcholinesterase, an enzyme that breaks down the neurotransmitter acetylcholine.

Fazadon is a small molecule with the synonyms AH 8165D, AH-8165D, BROMURE DE FAZADINIUM, BROMURO DE FAZADINIO, FAZADINIUM BROMIDE, and FAZADINIUM BROMIDE.

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	FAZADINIUM
Drug class	fazadinium
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of acetylcholine like a messenger in your brain that helps you move and respond to the world around you. When acetylcholinesterase breaks it down, the message is lost. Fazadinium helps keep the message going by blocking the enzyme, allowing acetylcholine to stay active for longer.

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:

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

Frequently asked questions about Fazadon

What is Fazadon?

Fazadon (FAZADINIUM) is a fazadinium drug.

How does Fazadon work?

Fazadinium works by blocking the action of acetylcholinesterase, an enzyme that breaks down the neurotransmitter acetylcholine.

What is the generic name of Fazadon?

FAZADINIUM is the generic (nonproprietary) name of Fazadon.

What drug class is Fazadon in?

Fazadon belongs to the fazadinium class. See all fazadinium drugs at /class/fazadinium.

What development phase is Fazadon in?

Fazadon is in Phase 2.

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

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