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Lanifibranor · 2 trials · 3 indications
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
| Arm | Type | Description |
|---|---|---|
| lanifibranor arm | ACTIVE_COMPARATOR | Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day. |
| Placebo | PLACEBO_COMPARATOR | Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo. |
| Experimental | EXPERIMENTAL | IMP Under investigation |
| Placebo to Match | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Lanifibranor | DRUG | The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day |
| Placebo | OTHER | Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo. |
| Moxifloxacin | DRUG | Single oral dose at D-8 |
Inclusion Criteria: * Be able to communicate meaningfully with the investigator and legally competent to provide written informed consent * Have an age between 21 to 75 years inclusive * Subjects should be on stable standard of care and background therapy for ongoing chronic conditions, including s...
Lanifibranor is an investigational small molecule being studied for Nonalcoholic Fatty Liver Disease (NAFLD) and Type 2 Diabetes (T2DM). It has also been evaluated in healthy subjects. The drug is in clinical development and has not been approved by the FDA.
Lanifibranor is being developed by Inventiva S.A., a biopharmaceutical company listed on the stock exchange under the ticker IVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Lanifibranor is in Phase 1 clinical development. It has completed a Phase 1 multiple ascending dose study in healthy subjects and a Phase 2 study in patients with NAFLD and Type 2 Diabetes. The drug is investigational and not yet approved.
Lanifibranor has completed two clinical trials: NCT03459079, a Phase 2 study in patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease, and NCT03866369, a Phase 1 multiple ascending dose study in healthy subjects. Both trials are completed.
Yes, Lanifibranor has received Breakthrough Therapy and Fast Track designations from the FDA. These designations are intended to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs.
Yes, Lanifibranor is also known as IVA337. The Phase 1 study NCT03866369 refers to Lanifibranor (IVA337) in its title, confirming that both names refer to the same drug.