Wednesday, July 8, 2026

Drug profile · INN

elafibranor

elafibranor (IQIRVO) is a peroxisome proliferator-activated receptor delta agonist. Associated with Ipsen. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Alimentary tract and metabolism (A05) A05AX06
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — elafibranor
US status
approved
Class
Alimentary tract and metabolism (A05)
Route
ORAL
Patents
0
Programs
4
Data quality
0.84

Quick answer

elafibranor (IQIRVO) is a peroxisome proliferator-activated receptor delta agonist. Associated with Ipsen. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN elafibranor
Brand IQIRVO
Mechanism Peroxisome proliferator-activated receptor delta agonist
Target Peroxisome proliferator-activated receptor alpha
Therapeutic class Alimentary tract and metabolism (A05)
Route ORAL
Formulation TABLET
ATC code A05AX06
Originator Ipsen

Mechanism of action

Peroxisome proliferator-activated receptor delta agonist

Primary target: Peroxisome proliferator-activated receptor alpha

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. elafibranor, Elafibranor Placebo Phase 3 · Ipsen · Primary Biliary Cholangitis (PBC)
  2. elafibranor, Placebo Phase 3 · Ipsen · Primary Biliary Cholangitis
  3. elafibranor, Placebo tablet Phase 3 · Ipsen · Primary Biliary Cholangitis
  4. CLIN-60190-453 Phase 2 · Ipsen · Primary Sclerosing Cholangitis

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is elafibranor?

elafibranor (IQIRVO) is a peroxisome proliferator-activated receptor delta agonist. Associated with Ipsen. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for elafibranor?

IQIRVO is a marketed brand name for elafibranor. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of elafibranor?

elafibranor 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.