Last reviewed 2026-05-26 · How we verify

Phenizine (PHENIPRAZINE)

Phase 2 active Small molecule ✓ Verified May 2026

Phenizine (generic name: PHENIPRAZINE) is a pheniprazine drug. It is currently in Phase 2 development.

Pheniprazine works by inhibiting the enzyme amine oxidase [flavin-containing] A, which breaks down certain neurotransmitters in the brain.

Pheniprazine is a small molecule with the synonyms FENIPRAZINA, PHENIPRAZINE, PHENIPRAZINE, and PHENIPRAZINE DL-FORM.

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	PHENIPRAZINE
Drug class	pheniprazine
Target	Amine oxidase [flavin-containing] A, Amine oxidase [flavin-containing] B
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of it like a traffic cop in the brain. The enzyme amine oxidase [flavin-containing] A is like a traffic cop that helps break down certain chemicals, or neurotransmitters, that help our brain cells communicate. By blocking this traffic cop, pheniprazine can help increase the levels of these neurotransmitters, which can help improve mood and other brain functions.

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:

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

Frequently asked questions about Phenizine

What is Phenizine?

Phenizine (PHENIPRAZINE) is a pheniprazine drug.

How does Phenizine work?

Pheniprazine works by inhibiting the enzyme amine oxidase [flavin-containing] A, which breaks down certain neurotransmitters in the brain.

What is the generic name of Phenizine?

PHENIPRAZINE is the generic (nonproprietary) name of Phenizine.

What drug class is Phenizine in?

Phenizine belongs to the pheniprazine class. See all pheniprazine drugs at /class/pheniprazine.

What development phase is Phenizine in?

Phenizine is in Phase 2.

What does Phenizine target?

Phenizine targets Amine oxidase [flavin-containing] A, Amine oxidase [flavin-containing] B and is a pheniprazine.

Drug class: All pheniprazine drugs
Target: All drugs targeting Amine oxidase [flavin-containing] A, Amine oxidase [flavin-containing] B
Therapeutic area: All drugs in Neuroscience

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