Lanifibranor Drug Asset Due Diligence Report 2026

This Lanifibranor Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 3

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Lanifibranor can convert its Small molecule drug profile and PPARα x PPARγ x PPARδ biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Lanifibranor (query alias: lanifibranor)
Modality / target	Small molecule drug; PPARα x PPARγ x PPARδ; PPARα agonists, PPARγ agonists, PPARδ agonists
Highest global status	Phase 3
Originator	AbbVie, Inc.
Active developers	Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Inventiva SA, AbbVie, Inc.

The MCP disease footprint includes Fibrosis, Liver, Inflammation, Liver Cirrhosis. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
CTR20232876	Phase 3	进行中（招募中）	81	Not disclosed
NCT05232071	Phase 2	Completed	42	Assessment of the effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24
JPRN-jRCT2031240629	Phase 1	Not Recruiting	32	Adverse event reports, vital signs measurements, electrocardiograms, physical examinations, and laboratory tests.

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Pan-PPAR agonist lanifibranor improves insulin resistance and hepatic steatosis in patients with T2D and MASLD

Phase 2; n=38; evaluation: Positive. Reported fields: IHTG(FAS) = -12 % ; IHTG(FAS) = -44 %

Efficacy, Safety and Mechanism of Action of Lanifibranor (IVA337) in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

Phase 2; n=128; evaluation: not stated. Reported fields: Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS)(Least Squares Mean) = -3.0 percentage decrease from baseline (95% Confidence Interval, -5.9 to -0.2); -; Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS)(Least Squares Mean) = -8.7 percentage decrease from baseline (95% Confidence Interval, -11.3 to -6.0)

The pan-PPAR agonist lanifibranor improves cardiometabolic health in patients with metabolic dysfunction-associated steatohepatitis.

Phase 2; n=not disclosed; evaluation: Positive. Reported fields: Weight Gain = 2.5 kg

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Lanifibranor addresses Fibrosis, Liver, Inflammation, Liver Cirrhosis. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 3 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2023-09-20	Inventiva and Hepalys Pharma, Inc. announce exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea	Phase 3	US$10.0M upfront; US$231.0M milestones
2022-09-21	Inventiva and Sino Biopharm announce licensing and collaboration agreement to develop and commercialize lanifibranor in Greater China	Phase 3	US$12.0M upfront; US$295.0M milestones
2021-02-25	Angers University to develop non-invasive biomarkers for identifying Inventiva's lanifibranor response in patients with NASH and fibrosis.	Phase 2	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Synthesis of lanifibranor”. The milestone feed surfaced a patent-application signal described as “Synthesis of lanifibranor”. The milestone feed surfaced a patent-application signal described as “Method of making lanifibranor”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO