Last reviewed 2026-05-19 · How we verify

LUBELUZOLE

Phase 2 active Small molecule ✓ Verified May 2026

LUBELUZOLE is a drug. It is currently in Phase 2 development.

Lubeluzole is thought to work by modulating ion channels and neurotransmitter release.

Lubeluzole is a small molecule. Its mechanism of action is 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	LUBELUZOLE
Target	Calmodulin, Sodium channel protein type 2 subunit alpha
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain cells communicating with each other through electrical signals. Lubeluzole helps regulate these signals by affecting the channels that allow them to flow in and out of the cells. This can help restore balance to the brain's communication system.

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:

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

Frequently asked questions about LUBELUZOLE

What is LUBELUZOLE?

LUBELUZOLE is a Small molecule drug.

How does LUBELUZOLE work?

Lubeluzole is thought to work by modulating ion channels and neurotransmitter release.

What development phase is LUBELUZOLE in?

LUBELUZOLE is in Phase 2.

What does LUBELUZOLE target?

LUBELUZOLE targets Calmodulin, Sodium channel protein type 2 subunit alpha.

Target: All drugs targeting Calmodulin, Sodium channel protein type 2 subunit alpha
Therapeutic area: All drugs in Neuroscience

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