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Iqirvo (ELAFIBRANOR)
Iqirvo works by activating peroxisome proliferator-activated receptors to improve liver function.
Iqirvo (elafibranor) is a small molecule peroxisome proliferator-activated receptor agonist developed by Ipsen. It is approved for the treatment of primary biliary cholangitis (PBC) and decompensated cirrhosis. Iqirvo works by activating specific receptors in the body to improve liver function. It has a long half-life of 70.2 hours and is patented, with no generic manufacturers available. Iqirvo was FDA-approved in 2024.
At a glance
| Generic name | ELAFIBRANOR |
|---|---|
| Sponsor | Ipsen |
| Drug class | Peroxisome Proliferator-activated Receptor Agonist [EPC] |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPAR-alpha, PPAR-gamma, and PPAR-delta in vitro. However, the mechanism by which elafibranor exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPAR-alpha and PPAR-delta. The signaling pathway for PPAR-delta was reported to include Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol. An in vitro PPAR functional assay showed that both elafibranor and GFT1007 produced activation of PPAR-alpha (EC 50 = 46 nM and 14 nM, respectively, and E max = 56% and 61%, respectively, relative to reference agonists). The potency of elafibranor and GFT1007 for PPAR-alpha activation exceeded the re
Approved indications
- Primary biliary cholangitis (PBC)
- Decompensated cirrhosis
Common side effects
- Weight gain
- Diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Arthralgia
- Constipation
- Muscle pain
- Fracture
- Gastroesophageal reflux disease
- Dry mouth
- Weight loss
Drug interactions
- Hormonal Contraceptives
- HMG-CoA Reductase Inhibitors
- Rifampin
- Bile Acid Sequestrants
- Hormonal Contraceptives
- HMG-CoA Reductase Inhibitors
- Rifampin
- Bile Acid Sequestrants
- Hormonal Contraceptives
- HMG-CoA Reductase Inhibitors
- Rifampin
- Bile Acid Sequestrants
Key clinical trials
- A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
- A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. (PHASE3)
- Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (PHASE3)
- A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis (PHASE3)
- A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. (PHASE2)
- A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) (PHASE3)
- A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis (PHASE3)
- A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Iqirvo CI brief — competitive landscape report
- Iqirvo updates RSS · CI watch RSS
- Ipsen portfolio CI