Drug

Fenofibric acid

As of the edition of 20 October 2026, Fenofibric acid is a small molecule: marketed, first approved in 2008 (US); acts on PPARA; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2008
Kind
Small molecule
Brand name
Trilipix
First approved
15 December 2008 (US)
Approvals on record
4 in 1 region
Holder of the most recent approval
ROSEMOUNT PHARMACEUTICALS LLC; 2 holders in all
Registered trials
25, 0 stopped early
Disease areas
Nutrition and metabolism; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Cancer; Hormones

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Fenofibric acid.

Target

GeneProteinUniProt
PPARAPeroxisome proliferator-activated receptor alphaQ07869

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 1151500
Phase 24310
Phase 34400
Phase 41010
All trials25

Who has held its approvals

CompanyRoleYears
AbbottOriginator and Lead sponsor of trials2007 to now
AbbVieAcquired holder and Lead sponsor of trials2008 to now