IQIRVO (elafibranor)
IQIRVO treats adults with primary biliary cholangitis (PBC) who have not had a sufficient response to standard therapy with ursodeoxycholic acid (UDCA). It is also used as a standalone option for patients who are unable to tolerate UDCA. This medication helps manage the condition by lowering alkaline phosphatase levels, though it is not recommended for those with advanced liver issues like decompensated cirrhosis.
How IQIRVO Works
This medication works by activating peroxisome proliferator-activated receptors (PPAR), specifically the alpha, delta, and gamma subtypes. By targeting these receptors, the drug helps inhibit the synthesis of bile acids from cholesterol, a process that involves reducing the activity of the enzyme CYP7A1.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-06-10
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- TABLET
IQIRVO Approval History
What IQIRVO Treats
1 indicationsIQIRVO is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Primary Biliary Cholangitis
IQIRVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to IQIRVO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07387549 ELASCOPE | CLIN-60190-475 2026-525242-29-00 | Ph 3 | recruiting | A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis |
| NCT06016842 ELFIDENCE | CLIN-60190-454 2023-505251-43-00 | Ph 3 | recruiting | A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis |
| NCT06730061 ELONSEN | CLIN-60190-462 | Ph 3 | active not recruiting | A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) |
| NCT06383403 ELSPIRE | CLIN-60190-463 2024-510695-20-00 | Ph 3 | active not recruiting | A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. |
| NCT05564208 | CLIN-60190-452 2022-001883-91 | Ph 1 | completed | A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet |
| NCT05543369 | CLIN-60190-450 | Ph 1 | completed | Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants |
| NCT02704403 RESOLVE-IT results posted | GFT505-315-1 2015-005385-38 | Ph 3 | terminated | Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) |
| NCT03985969 | GFT505-119-15 2019-001451-38 | Ph 1 | completed | Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin |
| NCT04171752 | GFT505-119-16 2019-001819-23 | Ph 1 | completed | Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers |
| NCT03844555 | GFT505-118-13 2018-002481-39 | Ph 1 | completed | Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients |
| NCT03765671 | GFT505-118-14 | Ph 1 | completed | Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IQIRVO FDA Label Details
Indications & Usage
FDA Label (PDF)IQIRVO is indicated for the treatment of Primary Biliary Cholangitis.
IQIRVO Patents & Exclusivity
Patents (9 active)
Exclusivity
Pro Intelligence Preview
Deep insights for IQIRVO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 9 active patents
Trial Analysis
- • 12 total trials
- • Stage: Expansion
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment