Wednesday, July 8, 2026

Drug profile · INN

fenofibrate

fenofibrate (APO-FENOFIBRATE) is a peroxisome proliferator-activated receptor alpha agonist. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Cardiovascular system (C10) C10BA04
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — fenofibrate
US status
approved
Class
Cardiovascular system (C10)
Route
ORAL
Patents
0
Programs
5
Data quality
0.89

Quick answer

fenofibrate (APO-FENOFIBRATE) is a peroxisome proliferator-activated receptor alpha agonist. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN fenofibrate
Brand APO-FENOFIBRATE
Mechanism Peroxisome proliferator-activated receptor alpha agonist
Target Peroxisome proliferator-activated receptor alpha
Therapeutic class Cardiovascular system (C10)
Route ORAL
Formulation CAPSULE
ATC code C10BA04

Mechanism of action

Peroxisome proliferator-activated receptor alpha agonist

Primary target: Peroxisome proliferator-activated receptor alpha

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. Fenofibrate Phase 3 · Xijing Hospital of · Primary Biliary Cirrhosis
  2. Pravafenix 40 mg/160 mg hard capsules Phase 3 · HRA Pharma · Dyslipidaemia
  3. Lapaquistat acetate and fenofibrate Phase 2 · Takeda · Hyperlipidemias
  4. Micronized DHACM 40 mg Phase 2 · United Therapeutics Europe · Knee Osteoarthritis
  5. Fenofibrate 145 mg Approved · United Therapeutics Europe · Diabetic Retinopathy

Related & competitor drugs

  1. alirocumab Cardiovascular system (C10)
  2. aliskiren Cardiovascular system (C09)
  3. azilsartan medoxomil Cardiovascular system (C09)
  4. bempedoic acid Cardiovascular system (C10)
  5. bosentan Cardiovascular system (C02)
  6. clofibrate Peroxisome proliferator-activated receptor alpha agonist

Frequently asked questions

What is fenofibrate?

fenofibrate (APO-FENOFIBRATE) is a peroxisome proliferator-activated receptor alpha agonist. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for fenofibrate?

APO-FENOFIBRATE is a marketed brand name for fenofibrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fenofibrate?

fenofibrate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.