Asset profile

Lanifibranor

Small molecule

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Evidence outlook · lead readout

LEGEND (NCT05232071) · NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2

The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.

LEGEND (NCT05232071): This trial was randomized, blinded, and placebo-controlled, and its posted results showed lanifibranor and lanifibranor-plus-empagliflozin both significantly lowered HbA1c versus placebo at 24 weeks. However, the trial enrolled only 39 patients across three arms, explicitly designed as an early proof-of-concept study, which is too small to serve as strong, confirmatory evidence on its own.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

Also in development:Metabolic Dysfunction-Associated Steatohepatitis

How the evidence outlook works ↗

Competitive landscape

70 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 69 same-indication; 34 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Lanifibranor: this drugPhase 3Small moleculePPAR (pan-agonist), Peroxisome proliferator-activated receptors (PPARs)
Chiglitazar (Bilessglu)Phase 3Small moleculePPAR (pan-agonist)
AfrezzaApprovedPeptideInsulin receptor (basal), Insulin
Alogliptin (Nesina)ApprovedSmall moleculeDPP-4
Bexagliflozin (Brenzavvy)ApprovedSmall moleculeSGLT2
Canagliflozin (Invokana)ApprovedSmall moleculeSGLT2
Dapagliflozin (Farxiga / Forxiga)ApprovedSmall moleculeSGLT2
Dulaglutide (Trulicity)ApprovedPeptideGLP-1 receptor
Empagliflozin (Jardiance)ApprovedSmall moleculeSGLT2
Ertugliflozin (Steglatro)ApprovedSmall moleculeSGLT2
Glipizide (Glucotrol)ApprovedSmall moleculeSulfonylurea receptor (SUR1)
Glyburide (Diabeta / Micronase)ApprovedSmall moleculeSulfonylurea receptor (SUR1)
Insulin Aspart (NovoLog / Fiasp)ApprovedPeptideInsulin receptor
Insulin Degludec (Tresiba)ApprovedPeptideInsulin receptor (basal)
Insulin Detemir (Levemir)ApprovedPeptideInsulin receptor (basal)
Insulin Glargine (Lantus / Toujeo)ApprovedPeptideInsulin receptor (basal)

…and 55 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
September 2027 (1)
Phase 3NASH - Nonalcoholic SteatohepatitisActive not recruiting
Est. primary completion 2027-09-30 · NCT04849728 · CT.gov ↗
What to watch
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 2 (4)
Phase 1 (2)