Last reviewed 2026-05-24 · How we verify

Cordoxene (FENALCOMINE)

Phase 2 active Small molecule ✓ Verified May 2026

Cordoxene (generic name: FENALCOMINE) is a fenalcomine drug. It is currently in Phase 2 development.

Fenalcomine is thought to work by interacting with a specific target in the body to produce a therapeutic effect.

Cordoxene is a small molecule with the synonyms FENALCOMINA and FENALCOMINE. Its exact mechanism and indications are not specified in the provided information.

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	FENALCOMINE
Drug class	fenalcomine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking the right response is a specific molecule. Fenalcomine is designed to fit into this lock, allowing the cell to respond in a way that treats a particular condition. This is a simplified explanation of how fenalcomine works at a molecular level.

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:

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

Frequently asked questions about Cordoxene

What is Cordoxene?

Cordoxene (FENALCOMINE) is a fenalcomine drug.

How does Cordoxene work?

Fenalcomine is thought to work by interacting with a specific target in the body to produce a therapeutic effect.

What is the generic name of Cordoxene?

FENALCOMINE is the generic (nonproprietary) name of Cordoxene.

What drug class is Cordoxene in?

Cordoxene belongs to the fenalcomine class. See all fenalcomine drugs at /class/fenalcomine.

What development phase is Cordoxene in?

Cordoxene is in Phase 2.

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

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