Last reviewed 2026-05-19 · How we verify

Clofenpyride (NICOFIBRATE)

Phase 2 active Small molecule ✓ Verified May 2026

Clofenpyride (generic name: NICOFIBRATE) is a nicofibrate drug. It is currently in Phase 2 development.

Clofenpyride works by inhibiting the enzyme acyl-CoA:cholesterol acyltransferase (ACAT), which plays a key role in the formation of cholesterol esters in the liver.

Clofenpyride is a small molecule with synonyms NICOFIBRATE and NICOFIBRATO. Its exact mechanism and indications are not specified in the provided information, but it is classified as a small molecule.

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	NICOFIBRATE
Drug class	nicofibrate
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a traffic cop: ACAT is like a traffic cop that helps cholesterol get into the liver and get stored. By blocking ACAT, Clofenpyride helps reduce the amount of cholesterol that gets stored in the liver, which can help lower cholesterol levels in the blood.

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:

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

Frequently asked questions about Clofenpyride

What is Clofenpyride?

Clofenpyride (NICOFIBRATE) is a nicofibrate drug.

How does Clofenpyride work?

Clofenpyride works by inhibiting the enzyme acyl-CoA:cholesterol acyltransferase (ACAT), which plays a key role in the formation of cholesterol esters in the liver.

What is the generic name of Clofenpyride?

NICOFIBRATE is the generic (nonproprietary) name of Clofenpyride.

What drug class is Clofenpyride in?

Clofenpyride belongs to the nicofibrate class. See all nicofibrate drugs at /class/nicofibrate.

What development phase is Clofenpyride in?

Clofenpyride is in Phase 2.

Drug class: All nicofibrate drugs
Therapeutic area: All drugs in Metabolic

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