Last reviewed 2026-05-27 · How we verify

LINOPIRDINE

Phase 2 active Small molecule ✓ Verified May 2026

LINOPIRDINE is a linopirdine drug. It is currently in Phase 2 development.

LinoPIRDINE works by blocking potassium channels in the brain, which helps to regulate the flow of electrical signals.

Linopiridine is a small molecule with the synonyms DUP 996, DUP-996, Lino piridina, Lino piridine, and Lino piridine.

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	LINOPIRDINE
Drug class	linopirdine
Target	Potassium voltage-gated channel subfamily KQT member 2, Potassium voltage-gated channel subfamily KQT member 4, Potassium voltage-gated channel subfamily KQT member 5
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of your brain as a city with many roads. Potassium channels are like traffic lights that control the flow of traffic. LinoPIRDINE acts like a traffic cop, blocking the traffic lights to slow down the flow of electrical signals in the brain.

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:

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

Frequently asked questions about LINOPIRDINE

What is LINOPIRDINE?

LINOPIRDINE is a linopirdine drug.

How does LINOPIRDINE work?

LinoPIRDINE works by blocking potassium channels in the brain, which helps to regulate the flow of electrical signals.

What drug class is LINOPIRDINE in?

LINOPIRDINE belongs to the linopirdine class. See all linopirdine drugs at /class/linopirdine.

What development phase is LINOPIRDINE in?

LINOPIRDINE is in Phase 2.

What does LINOPIRDINE target?

LINOPIRDINE targets Potassium voltage-gated channel subfamily KQT member 2, Potassium voltage-gated channel subfamily KQT member 4, Potassium voltage-gated channel subfamily KQT member 5 and is a linopirdine.

Drug class: All linopirdine drugs
Target: All drugs targeting Potassium voltage-gated channel subfamily KQT member 2, Potassium voltage-gated channel subfamily KQT member 4, Potassium voltage-gated channel subfamily KQT member 5
Therapeutic area: All drugs in Neuroscience

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