MN-166

Indicated For

Amyotrophic Lateral Sclerosis (ALS)

About This Medication

# MediciNova MN-166 (Ibudilast) Access Guide: How to Get Treatment at Low or No Cost **Important Note: MN-166 (ibudilast) is an investigational drug not yet approved by the FDA for ALS or any condition.** There is no traditional patient assistance program (PAP) offering free or discounted medication outside of clinical trials or expanded access programs (EAPs). MediciNova, the manufacturer, currently does **not** accept individual requests for expanded access due to focus on Phase 3 trials.[4] This guide explains current access options like the NIH-funded SEANOBI EAP, trial participation, and next steps for patients with ALS seeking MN-166.[1][2][3] ## About MN-166 (Ibudilast) MN-166 (ibudilast) is an oral small-molecule drug developed by MediciNova that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines like macrophage migration inhibitory factor (MIF). It shows promise in slowing ALS progression by reducing neuroinflammation.[2][3] Currently in late-stage development for ALS, it has FDA and EMA **Orphan Drug Designation** and FDA **Fast Track Designation**.[2][3] Two key studies are ongoing: - **COMBAT-ALS Phase 2b/3 Trial**: Randomized, placebo-controlled study with 234 patients in the US and Canada. Includes 12 months double-blind + 6 months open-label. Topline results expected end of 2026.[2][3] - **SEANOBI Expanded Access Program (EAP)**: NIH-funded ($22M NINDS grant under ACT for ALS). Provides MN-166 to ~200 ALS patients ineligible for randomized trials. Already enrolled 100+ patients at 12 US sites. Collects real-world data on outcomes and biomarkers like neurofilament levels.[1][2][3] **Who might benefit?** ALS patients not eligible for COMBAT-ALS. Speak to your neurologist about site availability.[1][2] ## Who Qualifies for Access? No income-based PAP exists, as MN-166 is experimental. Access is via: 1. **Clinical Trials** (e.g., COMBAT-ALS): Eligibility based on medical criteria (ALS diagnosis, disease stage), not income. 2. **Expanded Access (SEANOBI EAP)**: For ALS patients excluded from trials. No financial eligibility mentioned; funded by NIH so **likely free** to participants.[2][3] **MediciNova Policy**: Not accepting compassionate use requests to prioritize Phase 3 trials leading to potential approval.[4] ## Income Eligibility Breakdown **No income thresholds apply**, as this is not a commercial PAP. SEANOBI is government-funded for eligible ALS patients regardless of finances.[2] If approved post-2026, future PAPs may use Federal Poverty Level (FPL) guidelines like most drugs (e.g., <400-500% FPL). | Household Size | Typical PAP Threshold (Example) | MN-166 Status | |---------------|-------------------------------|---------------| | Individual | $50,000-$60,000 (<400% FPL) | **N/A - Trial/EAP Only** | | Couple | $65,000-$80,000 | **N/A - Trial/EAP Only** | | Family of 3 | $80,000-$95,000 | **N/A - Trial/EAP Only** | | Family of 4 | $95,000-$115,000 | **N/A - Trial/EAP Only** | *Table shows standard PAP examples; MN-166 has no such program currently.* ## Insurance Requirements **None for trials/EAPs**. These provide study drug at no cost. Medicare/Medicaid patients can participate. Private insurance irrelevant, as drug is experimental (not covered).[2][3] Post-approval, Medicare Part D may cover if FDA-approved. ## Step-by-Step: How to Apply for Access 1. **Consult Your ALS Specialist**: Discuss MN-166 suitability. Ask about COMBAT-ALS or SEANOBI eligibility.[1][2] 2. **Check Trial Availability**: - Visit ClinicalTrials.gov (search "MN-166 ALS" or "ibudilast ALS" or "SEANOBI" or "COMBAT-ALS"). - COMBAT-ALS: 234 patients enrolled; check open slots.[2] - SEANOBI: 12 US sites, ~200 total; 100+ enrolled as of Jan 2026.[2][3] 3. **Contact Study Coordinators**: Your doctor submits inquiry. No direct patient applications.[1] 4. **Screening**: Medical evaluation (ALS diagnosis, exclusion from other trials for EAP).[2] 5. **Enrollment**: If eligible, receive MN-166 free via study. Regular monitoring required. **No MediciNova PAP application** - their site confirms no expanded access requests.[4] ## Timeline and Delivery - **Approval/Enrollment**: Varies by site; days to weeks post-screening. SEANOBI rapidly enrolling (1st patient 2025, 100 by Jan 2026).[1][2] - **Drug Delivery**: Provided at study sites or shipped; oral capsules taken daily. - **Study Duration**: COMBAT-ALS: 18 months. SEANOBI: Collects data over time.[2][3] ## If Denied or Ineligible: Alternatives - **Other ALS Trials**: Search ClinicalTrials.gov for ALS studies (e.g., Relyvrio, Qalsody if eligible). - **ALS PAPs**: For approved drugs like Riluzole/Edaravone via NeedyMeds.org or RxAssist.org. - **NIH ACT for ALS**: More EAPs possible. - **Manufacturer Contact**: MediciNova (info@medicinova.com) for trial updates.[4] - **ALS Associations**: ALS.org or ALSTDI.org for support/financial aid. ## Refills and Reauthorization Handled by study team. No patient-managed refills. ## Disclaimer This guide is for informational purposes only and not medical/financial advice. MN-166 is **investigational** - efficacy/safety unproven. Consult your healthcare provider. Program details may change; verify via ClinicalTrials.gov or MediciNova. No guarantees of access. (Word count: 912)

Program information last verified: March 25, 2026