# Lanifibranor by Inventiva

Canonical page: https://technooptimist.io/biotech/lanifibranor
Frontier: [Biotech](https://technooptimist.io/biotech.md) · Field: Fatty liver (MASH) · Company: [Inventiva](https://technooptimist.io/companies/inventiva.md)
Stage: Pilot (3 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2026-09-28, facts checked 2026-10-11
Goal: Give MASH patients with advanced scarring a pill that tackles fat, inflammation and fibrosis at once, by switching on the three receptors that run liver fat metabolism instead of hitting one pathway.
Status: Phase 3 NATiV3 fully dosed; topline due Q4 2026, US filing planned H1 2027 if positive.
Next milestone: NATiV3 topline results, target Q4 2026

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | Phase 2b NATIVE: gains on fibrosis and MASH resolution |   |   |
| Done | FDA Breakthrough Therapy designation |   |   |
| Done | NATiV3 randomisation complete (1,009 + 410 patients) | 1 Apr 2025 |   |
| Done | Last patient's 72-week visit | Sep 2026 |   |
| Current | NATiV3 topline results | Q4 2026 |   |
| Planned | US filing for accelerated approval (if positive) | 2027 |   |
| Planned | Possible US launch | 2028 |   |

## Upcoming events

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

## Most important updates

- **28 Sep 2026**: Inventiva: last NATiV3 patient completes 72 weeks; lanifibranor topline on track for Q4 2026. On its Q2 2026 call, Inventiva said the final NATiV3 patient finished the 72-week visit in September and topline results remain due in Q4 2026. ([our story](https://technooptimist.io/stories/inventiva-last-nativ3-patient-completes-72-weeks-lanifibranor-topline-657779d3.md) · [original source](https://www.marketbeat.com/instant-alerts/transcript-inventiva-q2-earnings-call-highlights-2026-09-28/))
- **1 Apr 2025**: Inventiva completes enrollment of its 1,009-patient phase 3 NATiV3 trial of lanifibranor in MASH. Inventiva finished randomising patients into NATiV3, the phase 3 trial of its daily pan-PPAR pill in MASH with moderate to advanced liver scarring. ([our story](https://technooptimist.io/stories/inventiva-completes-enrollment-of-its-1-009-patient-phase-3-nativ3-1ad9d765.md) · [original source](https://www.biospace.com/press-releases/inventiva-announces-completion-of-enrollment-in-the-phase-3-nativ3-clinical-trial-of-lanifibranor-in-patients-with-mash-and-advanced-fibrosis))

## Current obstacles

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

## Physics limits

- **Biopsies are a noisy yardstick**: MASH 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 slow**: Collagen 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

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

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About Inventiva

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).

- Headquarters: FR
- Status: public
- Website: https://inventivapharma.com
- People: Andrew Obenshain (Chief Executive Officer)

Company page: https://technooptimist.io/companies/inventiva.md

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Everything in Biotech: https://technooptimist.io/biotech.md

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