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In development

Ibudilast

Also known as MN-166

Bottom line

Two small earlier studies found no clear benefit, only after-the-fact hints, and many people could not tolerate high doses. COMBAT-ALS, a 234-person placebo-controlled trial, is the first real test; results are due by the end of 2026.

Ibudilast is a twice-daily pill that is thought to calm inflammation in the brain and spinal cord. Two earlier small studies in ALS did not show a clear benefit. MediciNova is now testing it in COMBAT-ALS, a 12-month placebo-controlled trial of 234 people that finished its blinded phase in September 2026. The main results are expected by the end of 2026.

Information checked 5 Nov 2026

Evidence: Hints only

Studies: 1 against · 1 mixed · 1 running

Controlled trials missed their main goal. Some measures or subgroups looked better, which needs confirming.

How we decide the overall verdict: How to read this site.

At a glance

CompanyMediciNovaExplanation and sources

MediciNova is a small company based in La Jolla, California, listed in both the US and Tokyo. Ibudilast (MN-166) is its lead drug and is also being studied in multiple sclerosis and other conditions. It reported $25.4 million in cash in mid-2026.

Sources

  1. MediciNova Announces Completion of Last Patient, Last Visit in the Double-Blind Portion of the Phase 2b/3 COMBAT-ALS TrialMediciNova · 24 Sept 2026 · Company press release
  2. MediciNova (MNOV) news summariesStockTitan · News
How it worksCalms inflammation-driving immune cells in the nervous systemPDE4 and macrophage migration inhibitory factor (MIF) inhibitorExplanation and sources

Ibudilast blocks an enzyme called PDE4 and an inflammatory signal called MIF. In ALS, immune cells in the nervous system (glia) become overactive and may damage motor neurons; ibudilast is meant to damp this down and reduce oxidative stress. Lab studies also suggest it helps clear clumps of the TDP-43 and SOD1 proteins. A small 2021 open-label study at high dose did not show changes in a brain inflammation scan or in neurofilament levels.

Sources

  1. MediciNova Announces Completion of Last Patient, Last Visit in the Double-Blind Portion of the Phase 2b/3 COMBAT-ALS TrialMediciNova · 24 Sept 2026 · Company press release
  2. COMBAT-ALS: a Phase IIb/III trial of MN-166 (ibudilast) in ALS - trial update (2021 poster)MediciNova · Conference presentation
  3. Ibudilast (MN-166) in amyotrophic lateral sclerosis - an open label, safety and pharmacodynamic trialPubMed Central · Peer-reviewed paper
StagePhase 2/3Phase 2b/3 COMBAT-ALS blinded phase done; results due by end of 2026Explanation and sources

COMBAT-ALS randomised 234 people in the US and Canada to ibudilast or placebo for 12 months. The last blinded visit happened in September 2026, and the company is now locking and analysing the data. People still in the study are taking ibudilast in an open-label extension that ends around March 2027.

Sources

  1. MediciNova Announces Completion of Last Patient, Last Visit in the Double-Blind Portion of the Phase 2b/3 COMBAT-ALS TrialMediciNova · 24 Sept 2026 · Company press release
  2. COMBAT-ALS Phase 2b/3 trial of MN-166 (NCT04057898)ClinicalTrials.gov · Trial registry
Best reported effectNot reported yet (COMBAT-ALS results due end-2026)CAFS (function and survival combined), 12 monthsExplanation and sources

COMBAT-ALS has not reported results. Its main measure, CAFS, combines change in daily function with survival. An earlier 6-month trial in 51 people found no overall difference from placebo; the company has highlighted a later look-back analysis in which more people on ibudilast stayed stable, but such responder analyses are weak evidence. A separate open-label study at a higher dose found no change in a brain inflammation scan or in blood neurofilament, and about a third of people stopped early because of side effects.

This is the most favourable result reported. See all key studies for the full picture.

Sources

  1. COMBAT-ALS Phase 2b/3 trial of MN-166 (NCT04057898)ClinicalTrials.gov · Trial registry
  2. MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis in a Phase IIb/III Study: COMBAT-ALS Study DesignNeurodegenerative Disease Management · Peer-reviewed paper
  3. Ibudilast (MN-166) in amyotrophic lateral sclerosis - an open label, safety and pharmacodynamic trialPubMed Central · Peer-reviewed paper
Who it's forAdults 18-80 within 18 months of first weakness, breathing ≥70%Early stage · Pill, up to 50 mg twice dailyExplanation and sources

COMBAT-ALS enrolled people with sporadic or familial ALS whose first weakness began within the last 18 months and whose breathing capacity was at least 70% of normal. Riluzole and edaravone were allowed.

Sources

  1. COMBAT-ALS Phase 2b/3 trial of MN-166 (NCT04057898)ClinicalTrials.gov · Trial registry
What's nextCOMBAT-ALS topline resultsExpected Q4 2026Explanation and sources

MediciNova has said several times, most recently in its 12 October 2026 shareholder update, that it expects to report topline results from the blinded part of COMBAT-ALS by the end of 2026.

Sources

  1. MediciNova CEO Provides Shareholder UpdateMediciNova · 12 Oct 2026 · Company press release
  2. MediciNova Announces Completion of Last Patient, Last Visit in the Double-Blind Portion of the Phase 2b/3 COMBAT-ALS TrialMediciNova · 24 Sept 2026 · Company press release
Can I join?Trials no longer enrolling; expanded access programme is fullExplanation and sources

COMBAT-ALS closed recruitment in September 2025. SEANOBI-ALS, an NIH-funded expanded access programme led by Mayo Clinic for people who cannot join trials, reached its 200-person target in mid-2026 and is no longer enrolling. MediciNova says it supports individual expanded access for people finishing COMBAT-ALS who want to continue.

Sources

  1. COMBAT-ALS Phase 2b/3 trial of MN-166 (NCT04057898)ClinicalTrials.gov · Trial registry
  2. SEANOBI-ALS expanded access for ibudilast (NCT06743776)ClinicalTrials.gov · Trial registry
  3. MediciNova Announces Patient Enrollment Milestone Achieved in SEANOBI Study Expanded-Access-Program Evaluating MN-166 in ALSMediciNova · 15 Jul 2026 · Company press release
  4. MediciNova Announces Update and Baseline Characteristics of COMBAT-ALS Presented at the 36th International Symposium on ALS/MNDMediciNova · 8 Dec 2025 · Company press release

Signal: Active

Signal measures how often, and how reliably, MediciNova tells the public about this drug. It says nothing about whether the drug works. A quiet company isn't necessarily a bad sign, but regular, on-time updates help patients plan.

Last company update12 Oct 2026 (24 days ago)40 / 40
Company updates in the last 12 months529 / 35
Promises keptNot enough history yet (neutral score)12.5 / 25
Signal score82 / 100 · Active

Announced milestones

70 or more is Active, 45 or more is Steady, 20 or more is Quiet, below 20 is Silent. Full method.

Timeline

9 events, newest first. Company updates are marked; independent news and regulator decisions are shown too.

2026

  1. Investor updateFrom the companyMediciNova

    CEO shareholder update keeps end-2026 results timing

    MediciNova's CEO said the company remains on track to report COMBAT-ALS topline results by year end.

  2. Press releaseFrom the companyMediciNova

    Last blinded visit completed in COMBAT-ALS

    All participants finished the 12-month placebo-controlled phase. The company moves to database lock and analysis, with topline results expected by the end of 2026.

  3. Investor updateFrom the companyMediciNova (via StockTitan)

    Investor conferences; COMBAT-ALS data still expected by year end

    Ahead of two September investor conferences, MediciNova repeated its end-of-2026 timing for COMBAT-ALS results.

  4. Press releaseFrom the companyMediciNova

    MediciNova confirms 200 people enrolled in SEANOBI-ALS

    Final follow-ups are expected in early 2027, after which the academic lead investigator will analyse and publish the data.

  5. NewsWideTrial (PR Newswire)

    SEANOBI-ALS expanded access programme stops enrolling

    WideTrial said the programme reached its 200-person target and is no longer taking new patients.

2025

  1. Press releaseFrom the companyMediciNova

    Baseline characteristics presented at the International ALS/MND Symposium

    Participants averaged 60.6 years old, 12.5 months from first symptoms and an ALSFRS-R score of 40.6, similar to other ALS trials.

  2. Press releaseFrom the companyMediciNova

    COMBAT-ALS enrolment closed at 234 people

    Recruitment officially closed with 234 people randomised in the US and Canada. The company said topline results were expected by the end of 2026.

  3. Press releaseFrom the companyMediciNova

    COMBAT-ALS reaches its enrolment target

    MediciNova said the Phase 2b/3 trial had enrolled the target number of participants, after a slow recruitment period that began in 2020.

  4. Press releaseFrom the companyMediciNova

    First patient enrolled in NIH-funded expanded access programme

    SEANOBI-ALS, led by Mayo Clinic with WideTrial, started giving ibudilast to people with ALS who cannot join clinical trials, while also collecting biomarker data.

All sources for this page

  1. COMBAT-ALS Phase 2b/3 trial of MN-166 (NCT04057898)ClinicalTrials.gov · Trial registry
  2. SEANOBI-ALS expanded access for ibudilast (NCT06743776)ClinicalTrials.gov · Trial registry
  3. MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis in a Phase IIb/III Study: COMBAT-ALS Study DesignNeurodegenerative Disease Management · Peer-reviewed paper
  4. Ibudilast (MN-166) in amyotrophic lateral sclerosis - an open label, safety and pharmacodynamic trialPubMed Central · Peer-reviewed paper
  5. COMBAT-ALS: a Phase IIb/III trial of MN-166 (ibudilast) in ALS - trial update (2021 poster)MediciNova · Conference presentation
  6. MediciNova Announces Completion of Patient Enrollment in COMBAT-ALS Phase 2b/3 Clinical Trial of MN-166 (ibudilast)MediciNova · 22 Sept 2025 · Company press release
  7. MediciNova Announces Update and Baseline Characteristics of COMBAT-ALS Presented at the 36th International Symposium on ALS/MNDMediciNova · 8 Dec 2025 · Company press release
  8. MediciNova Announces Patient Enrollment Milestone Achieved in SEANOBI Study Expanded-Access-Program Evaluating MN-166 in ALSMediciNova · 15 Jul 2026 · Company press release
  9. MediciNova Announces Completion of Last Patient, Last Visit in the Double-Blind Portion of the Phase 2b/3 COMBAT-ALS TrialMediciNova · 24 Sept 2026 · Company press release
  10. MediciNova CEO Provides Shareholder UpdateMediciNova · 12 Oct 2026 · Company press release
  11. MediciNova (MNOV) news summariesStockTitan · News
  12. MediciNova reports additional Phase Ib/IIa data for ibudilast in ALSBioCentury · News
  13. MediciNova Announces Additional Analyses from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 30th International Symposium on ALS/MNDMediciNova · Company press release