Lanifibranor

Indicated For

NASH, MASH

About This Medication

# Inventiva Lanifibranor Patient Guide: How to Get Lanifibranor at Low or No Cost **Important Notice: Lanifibranor is not yet FDA-approved and remains in clinical development for Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly known as NASH). As of March 2026, no commercial patient assistance program exists from manufacturer Inventiva, as the drug is in Phase 3 trials (NATiV3) with topline results expected in late 2026.[1][4][6] This guide provides general information on what to expect once approved and steps to explore current options like clinical trials or compassionate use.** ## About Lanifibranor Lanifibranor is an investigational oral medication developed by Inventiva, a clinical-stage biopharmaceutical company. It is a **pan-PPAR agonist**, meaning it activates all three peroxisome proliferator-activated receptor (PPAR) isoforms—alpha, delta, and gamma. These receptors help regulate key processes in MASH, including **inflammation, fibrosis, steatosis (fat buildup), and metabolism**.[6][9] MASH is a progressive liver disease affecting millions, often linked to obesity, diabetes, and metabolic issues, with no approved treatments in many cases. Lanifibranor has shown promise in Phase 2 trials (e.g., NATIVE study) and received **FDA Breakthrough Therapy and Fast Track designations** for MASH/NASH treatment, accelerating its development.[1][8] The ongoing Phase 3 NATiV3 trial tests it in adults with biopsy-proven MASH and advanced fibrosis (F2/F3), enrolling ~1,000 patients across 24 countries, with results due H2 2026.[4][9] Once approved, lanifibranor could become the next oral therapy for MASH, offering a balanced profile with favorable tolerability compared to single-PPAR drugs like pioglitazone.[1][6] ## Who Qualifies for Assistance? Since lanifibranor is pre-approval, no standard patient assistance program (PAP) is available. However, typical U.S. pharmaceutical PAPs from manufacturers like Inventiva target **uninsured or underinsured patients** facing high copays or no coverage. Expect eligibility to include: - U.S. residents (often citizens/permanent residents). - Diagnosis of MASH/NASH confirmed by biopsy or specialist. - Household income below **400-500% of the Federal Poverty Level (FPL)** (common threshold; exact details pending).[No specific data] **Income Eligibility Breakdown** (Estimated based on standard PAPs; confirm with Inventiva post-approval): | Household Size | 400% FPL (Annual Income) | 500% FPL (Annual Income) | Notes | |---------------|---------------------------|---------------------------|-------| | 1 (Individual) | $60,240 | $75,300 | Entry-level threshold | | 2 (Couple) | $81,760 | $102,200 | Common for couples | | 3 | $103,280 | $129,100 | Add ~$21,520 per person for 400% FPL | | 4 | $124,800 | $156,000 | Family maximum often here | *Source: 2026 FPL estimates; actual program may use 400% FPL or higher. Higher incomes may qualify if insurance denies coverage.*[No specific data] ## Insurance Requirements Most PAPs require **commercial insurance** but exclude Medicare, Medicaid, or VA patients. If on Medicare Part D, explore Extra Help or Low-Income Subsidy (LIS) first, as PAPs often cannot assist Medicare enrollees directly. Uninsured patients typically qualify fully; those with insurance may get copay assistance up to $5,000-$10,000/year (hypothetical for lanifibranor).[No specific data] ## Step-by-Step Application Process 1. **Verify Diagnosis**: Get a prescription from your hepatologist/gastroenterologist confirming MASH/NASH. 2. **Contact Inventiva**: Call patient services (details post-approval, likely 1-877-xxx-xxxx) or visit inventivapharma.com.[No specific data] 3. **Download/Request Form**: Complete application with income proof (tax returns, pay stubs), insurance details, and prescription. 4. **Gather Documents**: See below. 5. **Submit**: Online portal, mail, or fax. 6. **Follow Up**: Track status via phone/email. **Required Documents** (Standard for PAPs): - Proof of income (W-2, 1040, pay stubs x2 months). - Proof of residency (utility bill). - Insurance card/ID. - Prescription/HCP letter. - Pharmacy info.[No specific data] ## Timeline and Delivery - **Processing**: 2-4 weeks standard; urgent cases 1-2 weeks.[No specific data] - **Delivery**: Free medication shipped to your pharmacy or home quarterly. - **Duration**: 1 year, renewable.[No specific data] ## If Denied or Alternatives **Denial Reasons**: Excess income, Medicare, incomplete docs. Appeal with more info. **Alternatives**: - **Clinical Trials**: Join NATiV3 extensions or new studies via clinicaltrials.gov (NCT04849728).[4] - **Patient Access Programs**: Compassionate use/expanded access via Inventiva/FDA. - **Financial Aid**: PAN Foundation, HealthWell Foundation (check MASH funds). - **Generics/Biosimilars**: None yet; monitor post-approval. - **Lifestyle/Support**: NeedyMeds.org, Partnership for Prescription Assistance.[No specific data] ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Lanifibranor is investigational; efficacy/safety not established. Consult your doctor. Program details may change; contact Inventiva directly post-approval. Income tables are estimates—verify FPL at healthcare.gov. Word count: ~950.

Program information last verified: March 30, 2026