Last reviewed 2026-04-20 · How we verify

Lorcamide (LORCAINIDE)

Phase 2 active Small molecule

Lorcamide (generic name: LORCAINIDE) is a lorcainide drug. It is currently in Phase 2 development.

Lorcainide works by blocking sodium channels in the heart to regulate abnormal heart rhythms.

Lorcainide is a small molecule drug in the class of lorcainide, targeting the sodium channel protein type 5 subunit alpha. It is used to treat certain heart rhythm disorders. However, its commercial status and approved indications are unknown. Lorcainide has a half-life of 6.5 hours, but its bioavailability and off-patent status are not specified. As a result, its availability and usage may be limited.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	LORCAINIDE
Drug class	lorcainide
Target	Sodium channel subunit beta-1, Sodium channel subunit beta-2, Sodium channel subunit beta-3
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your heart is like a firework, with electrical signals that make it beat. Sometimes, these signals can get out of control and cause abnormal heart rhythms. Lorcainide helps to calm down these electrical signals by blocking the sodium channels that carry them, which helps to regulate the heartbeat.

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:

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

Frequently asked questions about Lorcamide

What is Lorcamide?

Lorcamide (LORCAINIDE) is a lorcainide drug.

How does Lorcamide work?

Lorcainide works by blocking sodium channels in the heart to regulate abnormal heart rhythms.

What is the generic name of Lorcamide?

LORCAINIDE is the generic (nonproprietary) name of Lorcamide.

What drug class is Lorcamide in?

Lorcamide belongs to the lorcainide class. See all lorcainide drugs at /class/lorcainide.

What development phase is Lorcamide in?

Lorcamide is in Phase 2.

What does Lorcamide target?

Lorcamide targets Sodium channel subunit beta-1, Sodium channel subunit beta-2, Sodium channel subunit beta-3 and is a lorcainide.

Drug class: All lorcainide drugs
Target: All drugs targeting Sodium channel subunit beta-1, Sodium channel subunit beta-2, Sodium channel subunit beta-3
Therapeutic area: All drugs in Cardiovascular

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