Last reviewed 2026-04-20 · How we verify

Ftoracizine (FLUACIZINE)

Phase 2 active Small molecule

Ftoracizine (generic name: FLUACIZINE) is a fluacizine drug. It is currently in Phase 2 development.

Ftoracizine is thought to work by interacting with a specific molecular target to produce its therapeutic effects.

Ftoracizine, also known as Fluacizine, is a small molecule drug in the fluacizine class. Unfortunately, there is limited information available on this compound, including its target, approved indications, and commercial status. As a result, it is difficult to provide a comprehensive summary of its use and safety profile. Further research is needed to determine the potential benefits and risks of Ftoracizine. Its development and current status are unclear.

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	FLUACIZINE
Drug class	fluacizine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Ftoracizine is a key that fits into one of those locks. When it binds to the lock, it can either block or enhance the normal functioning of the cell, depending on the specific target and the disease being treated. This can help to restore balance and alleviate symptoms.

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:

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

Frequently asked questions about Ftoracizine

What is Ftoracizine?

Ftoracizine (FLUACIZINE) is a fluacizine drug.

How does Ftoracizine work?

Ftoracizine is thought to work by interacting with a specific molecular target to produce its therapeutic effects.

What is the generic name of Ftoracizine?

FLUACIZINE is the generic (nonproprietary) name of Ftoracizine.

What drug class is Ftoracizine in?

Ftoracizine belongs to the fluacizine class. See all fluacizine drugs at /class/fluacizine.

What development phase is Ftoracizine in?

Ftoracizine is in Phase 2.

Drug class: All fluacizine drugs
Therapeutic area: All drugs in Other

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