Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elafibranor · 5 trials · 10 indications
Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.
In Healthy Young Adults compared to Healthy Elderly
In Healthy Young Adults compared to Healthy Elderly
In Healthy Young Adults compared to Healthy Elderly
of elafibranor
of elafibranor
In participants with end stage renal disease compared to healthy volunteers
In participants with end stage renal disease compared to healthy volunteers
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Elafibranor 80 mg | ACTIVE_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Elafibranor 120 mg | ACTIVE_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Young Adults | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Elderly | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| DDI | EXPERIMENTAL | Period 1: study of elafibranor's pharmacokinetics Period 2: study of elafibranor's pharmacokinetics under CHRONO-INDOCID® (indomethacin) at steady state |
| End Stage Renal Disease | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Healthy | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Mild Child-Pugh A | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Moderate Child-Pugh B | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Severe Child-Pugh C | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Name | Type | Description |
|---|---|---|
| Elafibranor 80 mg | DRUG | Two coated tablets daily for 12 weeks |
| Elafibranor 120 mg | DRUG | Two coated tablets daily for 12 weeks |
| Placebo | DRUG | Two coated tablets daily for 12 weeks |
| elafibranor | DRUG | elafibranor 120mg is a coated tablet for oral administration |
| CHRONO-INDOCID | DRUG | CHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration |
Inclusion Criteria: 1. Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: * History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit) * Positive...
Elafibranor is an investigational small molecule being studied for Primary Biliary Cholangitis (PBC). It is also being evaluated in clinical trials for renal impairment, hepatic impairment, drug-drug interactions, and geriatric populations, though these are pharmacokinetic studies rather than therapeutic indications.
Elafibranor is being developed by Genfit SA, which trades as a Sponsored ADR under the ticker GNFT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Primary Biliary Cholangitis.
Elafibranor is in Phase 1 clinical development. While one Phase 2 trial has been completed, the most advanced ongoing development stage is Phase 1, with studies evaluating pharmacokinetics in special populations. The drug is investigational and not yet approved.
Elafibranor has completed four clinical trials: NCT03124108, a Phase 2 study in Primary Biliary Cholangitis; NCT03844555, a Phase 1 renal impairment study; NCT03985969, a Phase 1 drug-drug interaction study; and NCT04171752, a Phase 1 geriatric study. All trials are completed.
Elafibranor is also known by its chemical name and has been referred to as GFT505 in some contexts. However, no alternative brand names have been established, and it is primarily identified by its generic name Elafibranor in clinical research.
Elafibranor is a small molecule that acts as a dual peroxisome proliferator-activated receptor (PPAR) agonist, targeting both PPAR-alpha and PPAR-delta. This mechanism is being studied for its potential effects in Primary Biliary Cholangitis and other metabolic conditions.