Last reviewed 2026-04-19 · How we verify

LOMERIZINE

Phase 2 active Small molecule

LOMERIZINE is a lomerizine drug. It is currently in Phase 2 development.

Lomerizine works by blocking calcium channels in the brain to reduce excessive neuronal activity.

Lomerizine is a small molecule drug that targets the voltage-dependent N-type calcium channel subunit alpha-1B. It is classified as a lomerizine, but its commercial status and approved indications are unknown. The mechanism of action involves blocking calcium channels to reduce neuronal excitability. As a result, lomerizine may be used to treat conditions characterized by excessive neuronal activity. However, its development and approval status are unclear.

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	LOMERIZINE
Drug class	lomerizine
Target	Voltage-dependent N-type calcium channel subunit alpha-1B
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain cells are like a group of excited kids in a classroom. They're all talking and moving around, making it hard to focus. Lomerizine helps calm them down by blocking the 'doors' that let calcium ions flow in, which helps reduce the noise and chaos.

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:

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

Frequently asked questions about LOMERIZINE

What is LOMERIZINE?

LOMERIZINE is a lomerizine drug.

How does LOMERIZINE work?

Lomerizine works by blocking calcium channels in the brain to reduce excessive neuronal activity.

What drug class is LOMERIZINE in?

LOMERIZINE belongs to the lomerizine class. See all lomerizine drugs at /class/lomerizine.

What development phase is LOMERIZINE in?

LOMERIZINE is in Phase 2.

What does LOMERIZINE target?

LOMERIZINE targets Voltage-dependent N-type calcium channel subunit alpha-1B and is a lomerizine.

Drug class: All lomerizine drugs
Target: All drugs targeting Voltage-dependent N-type calcium channel subunit alpha-1B
Therapeutic area: All drugs in Neuroscience

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