Last reviewed 2026-04-22 · How we verify

Comparator: fenofibrate monotherapy

Organon and Co · Phase 3 active Small molecule

Comparator: fenofibrate monotherapy is a Fibrate (PPARα agonist) Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia (as adjunct to diet).

Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol.

Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol. Used for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia (as adjunct to diet).

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Comparator: fenofibrate monotherapy
Sponsor	Organon and Co
Drug class	Fibrate (PPARα agonist)
Target	PPARα (Peroxisome proliferator-activated receptor alpha)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Fenofibrate works by binding to and activating PPARα, a nuclear receptor that regulates genes involved in lipid metabolism. This activation increases the catabolism of triglyceride-rich lipoproteins and reduces hepatic triglyceride production, while simultaneously increasing HDL cholesterol levels. It is commonly used as monotherapy or in combination with statins to manage dyslipidemia and reduce cardiovascular risk.

Approved indications

Hypertriglyceridemia
Mixed dyslipidemia
Primary hypercholesterolemia (as adjunct to diet)

Common side effects

Elevated liver enzymes (ALT/AST)
Myalgia or muscle pain
Gallstones (cholelithiasis)
Gastrointestinal upset
Headache

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.

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:

Comparator: fenofibrate monotherapy CI brief — competitive landscape report
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Frequently asked questions about Comparator: fenofibrate monotherapy

What is Comparator: fenofibrate monotherapy?

Comparator: fenofibrate monotherapy is a Fibrate (PPARα agonist) drug developed by Organon and Co, indicated for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia (as adjunct to diet).

How does Comparator: fenofibrate monotherapy work?

Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol.

What is Comparator: fenofibrate monotherapy used for?

Comparator: fenofibrate monotherapy is indicated for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia (as adjunct to diet).

Who makes Comparator: fenofibrate monotherapy?

Comparator: fenofibrate monotherapy is developed by Organon and Co (see full Organon and Co pipeline at /company/organon-and-co).

What drug class is Comparator: fenofibrate monotherapy in?

Comparator: fenofibrate monotherapy belongs to the Fibrate (PPARα agonist) class. See all Fibrate (PPARα agonist) drugs at /class/fibrate-ppar-agonist.

What development phase is Comparator: fenofibrate monotherapy in?

Comparator: fenofibrate monotherapy is in Phase 3.

What are the side effects of Comparator: fenofibrate monotherapy?

Common side effects of Comparator: fenofibrate monotherapy include Elevated liver enzymes (ALT/AST), Myalgia or muscle pain, Gallstones (cholelithiasis), Gastrointestinal upset, Headache.

What does Comparator: fenofibrate monotherapy target?

Comparator: fenofibrate monotherapy targets PPARα (Peroxisome proliferator-activated receptor alpha) and is a Fibrate (PPARα agonist).

Drug class: All Fibrate (PPARα agonist) drugs
Target: All drugs targeting PPARα (Peroxisome proliferator-activated receptor alpha)
Manufacturer: Organon and Co — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypertriglyceridemia
Indication: Drugs for Mixed dyslipidemia
Indication: Drugs for Primary hypercholesterolemia (as adjunct to diet)

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