Lanifibranor by Inventiva: status and timeline

Milestones

Next · NATiV3 topline results

Phase 2b NATIVE: gains on fibrosis and MASH resolutionDoneComplete.
FDA Breakthrough Therapy designationDoneComplete.
NATiV3 randomisation complete (1,009 + 410 patients)1 Apr 2025Complete.
Last patient's 72-week visitSep 2026Complete.
NATiV3 topline resultsTarget Q4 2026Current milestone.
US filing for accelerated approval (if positive)Target 2027Not yet reached.
Possible US launchTarget 2028Not yet reached.

Most important updates

Inventiva: last NATiV3 patient completes 72 weeks; lanifibranor topline on track for Q4 202613d ago
Inventiva completes enrollment of its 1,009-patient phase 3 NATiV3 trial of lanifibranor in MASH1 Apr 2025

Upcoming

Q4 2026NATiV3 topline results (next)
2027US filing for accelerated approval (if positive)
2027US NDA submission (if positive)
2028Possible US launch

Current obstacles

Weight gain and fluid retentionPPAR-gamma drugs add weight and oedema; phase 2b saw mostly mild-to-moderate cases. Phase 3 must show it is tolerable.
Crowded MASH marketRezdiffra is already approved and GLP-1 drugs are moving in; lanifibranor must add value alongside them.
Cash runwayFunding lasts into Q2 2027 (early 2028 if debt conditions met), so the readout decides the company's future.

Physics limits

Biopsies are a noisy yardstickMASH trials score tiny liver samples by eye; scarring is patchy, so pathologists disagree and placebo response is high, which blurs real drug effects.
Scar reversal is slowCollagen scars take years to remodel, so 72-week trials catch only early regression, and proof that patients avoid cirrhosis needs multi-year outcome trials.

How it works

4 parts

PPAR-alpha

Burns fat in the liver

Turns on the genes that break down fatty acids, lowering the fat load that injures liver cells.

PPAR-delta

Calms inflammation

Shifts liver immune cells away from inflammation and helps muscle burn fat.

PPAR-gamma (partial)

Better insulin sensitivity

Partial activation improves insulin response and quiets scar-making stellate cells, without full-dose side effects.

Endpoint

Biopsy-proven double win

Phase 3 asks whether one patient shows both MASH resolution and one stage less scarring on biopsy at 72 weeks.

Spec sheet

Spec	Lanifibranor
NATiV3 main cohort	1,009 patients (F2–F3 fibrosis)^R (reported)
Exploratory cohort	410 patients (mostly F1/F4)^R (reported)
Doses tested	800 mg and 1,200 mg daily^R (reported)
Treatment length	72 weeks^R (reported)
Phase 2b composite, placebo-adjusted	+24 points at 6 months^R (reported)
NATiV3 statistical power	90%^R (reported)

^R reported by the company

Update log

2 updates

Mon 28 Sep

Minor: Inventiva: last NATiV3 patient completes 72 weeks; lanifibranor topline on track for Q4 2026InterviewTest

Tue 1 Apr 2025

Minor: Inventiva completes enrollment of its 1,009-patient phase 3 NATiV3 trial of lanifibranor in MASHPressTest

About Inventiva

The team behind Lanifibranor

Inventiva

Lanifibranor, pan-PPAR pill, MASH

French biotech developing lanifibranor, a daily pill that switches on all three PPAR fat-metabolism receptors, for MASH with liver scarring. Its phase 3 NATiV3 reads out in Q4 2026.

NATiV3: 1,009-patient phase 3, last 72-week visit done Sep 2026; topline Q4 2026.
If positive: US filing H1 2027 for accelerated approval, possible 2028 launch.
€233.9M cash at 30 Jun 2026; runway into Q2 2027 (early 2028 with conditional debt).

inventivapharma.com (opens inventivapharma.com)Company profile →

Headquarters: France
Status: Public
Valuation: public
Works in: BiotechFatty liver (MASH)
Coverage: 1 program · 2 updateslatest 13d agochecked 11 Oct
People: Andrew ObenshainChief Executive Officer