Last reviewed 2026-04-19 · How we verify

LIDOFENIN

Phase 2 active Small molecule

LIDOFENIN is a lidofenin drug. It is currently in Phase 2 development.

Lidofenin is thought to work by interacting with a specific molecular target, but its exact mechanism of action is currently unknown.

Lidofenin is a small molecule drug of the lidofenin class, but its target and exact mechanism of action are unknown. It is not clear if it is FDA-approved or commercially available. As a result, there is limited information available on its approved indications, half-life, bioavailability, generic manufacturers, or patent status. Further research is needed to understand its clinical use and safety profile. Due to the lack of information, it is difficult to provide a comprehensive summary of lidofenin.

Likelihood of approval

15.3% 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).

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	LIDOFENIN
Drug class	lidofenin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and lidofenin is a key that fits into one of those locks. When it binds to the lock, it can either open the lock or block it from being opened by other keys. This can affect how the cell works, but the exact way it does this is still a mystery.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Pilot Study for Patients With Poor Response to Deferasirox (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about LIDOFENIN

What is LIDOFENIN?

LIDOFENIN is a lidofenin drug.

How does LIDOFENIN work?

Lidofenin is thought to work by interacting with a specific molecular target, but its exact mechanism of action is currently unknown.

What drug class is LIDOFENIN in?

LIDOFENIN belongs to the lidofenin class. See all lidofenin drugs at /class/lidofenin.

What development phase is LIDOFENIN in?

LIDOFENIN is in Phase 2.

Drug class: All lidofenin drugs
Therapeutic area: All drugs in Other

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