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Lipenan (CLOFIBRIDE)

Phase 2 active Small molecule

Lipenan (generic name: CLOFIBRIDE) is a clofibride drug. It is currently in Phase 2 development.

Lipenan works by inhibiting the synthesis of triglycerides in the liver.

Lipenan, also known as CLOFIBRIDE, is a small molecule drug in the clofibride class. It is a lipid-lowering agent, but its exact target and approved indications are unknown. The commercial status of Lipenan is unclear, and it may be patented or generic. Key safety considerations are not well-documented. Further research is needed to fully understand its pharmacology and clinical use.

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 nameCLOFIBRIDE
Drug classclofibride
ModalitySmall molecule
Therapeutic areaGastroenterology
PhasePhase 2

Mechanism of action

Think of it like a brake on a car - Lipenan slows down the liver's production of triglycerides, which are a type of fat that can build up in the blood and increase the risk of heart disease. By reducing triglyceride levels, Lipenan can help lower the risk of heart problems. This is especially important for people with high levels of triglycerides in their blood.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Lipenan

What is Lipenan?

Lipenan (CLOFIBRIDE) is a clofibride drug.

How does Lipenan work?

Lipenan works by inhibiting the synthesis of triglycerides in the liver.

What is the generic name of Lipenan?

CLOFIBRIDE is the generic (nonproprietary) name of Lipenan.

What drug class is Lipenan in?

Lipenan belongs to the clofibride class. See all clofibride drugs at /class/clofibride.

What development phase is Lipenan in?

Lipenan is in Phase 2.

Related

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