MN-166

Property	Information
Drug Name	MN-166 (Ibudilast)
Overview	MN-166 (Ibudilast) is a PDE4 inhibitor with anti-inflammatory properties approved in Japan for post-stroke complications and asthma. It is in late-stage trials for ALS, MS, and DCM, and early trials for glioblastoma suggest it may improve progression-free survival when combined with temozolomide. Its neuroprotective properties are also under investigation for Long COVID and substance use disorder, making it a versatile candidate for repurposed drug therapies.
FDA Approval	Approved in Japan for post-stroke complications and bronchial asthma; in late-stage clinical development for ALS, Progressive MS, DCM in other regions
Used for	Experimental for ALS, Progressive MS, DCM, glioblastoma, CIPN, Long COVID, and substance use disorder
Clinical Trial Phase	Phase 3 for ALS and DCM, Phase 3-ready for Progressive MS, Phase 2 for glioblastoma, Long COVID, and substance use disorder
Clinical Trial Explanation	In glioblastoma, a Phase 1b/2a trial evaluated MN-166 in combination with temozolomide (TMZ), showing it was safe and well-tolerated. Progression-Free Survival at 6 months (PFS6) was 44% in newly diagnosed patients and 31% in recurrent cases, with the latter improving over historical controls. MN-166 is also in a Phase 2b/3 trial for ALS (COMBAT-ALS), where interim analysis suggests it may slow disease progression. The trial is ongoing, with top-line data expected in 2026.Property "Has clinical trial explanation" (as page type) with input value "In glioblastoma, a Phase 1b/2a trial evaluated MN-166 in combination with temozolomide (TMZ), showing it was safe and well-tolerated. Progression-Free Survival at 6 months (PFS6) was 44% in newly diagnosed patients and 31% in recurrent cases, with the latter improving over historical controls. MN-166 is also in a Phase 2b/3 trial for ALS (COMBAT-ALS), where interim analysis suggests it may slow disease progression. The trial is ongoing, with top-line data expected in 2026." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.
Common Side Effects	Generally well-tolerated; possible mild gastrointestinal issues and fatigue. No unexpected adverse effects in clinical trials.
OS without	Not specified
OS with	Under investigation; preliminary results suggest potential for improved survival in glioblastoma patients.
PFS without	Not specified
PFS with	Phase 1b/2a data shows PFS6 of 44% in newly diagnosed glioblastoma and 31% in recurrent cases.
Usefulness Rating	4
Usefulness Explanation	MN-166 shows promise in glioblastoma when combined with temozolomide, with clinical trials indicating improved progression-free survival. It has demonstrated potential in slowing neurodegenerative disease progression (ALS, MS, DCM) and is undergoing further clinical validation.Property "Has Usefulness Explanation" (as page type) with input value "MN-166 shows promise in glioblastoma when combined with temozolomide, with clinical trials indicating improved progression-free survival. It has demonstrated potential in slowing neurodegenerative disease progression (ALS, MS, DCM) and is undergoing further clinical validation." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.
Toxicity Level	1
Toxicity Explanation	MN-166 has a well-documented safety profile with low toxicity. It is generally well-tolerated, though mild gastrointestinal symptoms and fatigue may occur. No unexpected adverse effects have been reported in glioblastoma or ALS clinical trials.

Notes: MN-166 (Ibudilast) is an anti-inflammatory small molecule that inhibits PDE4 and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It has been used in Japan for over 20 years with a well-documented safety profile. In glioblastoma, its ability to enhance TMZ effectiveness makes it a promising candidate for further research. Additionally, an NIH-funded Expanded Access Protocol is providing MN-166 to ALS patients to evaluate its impact on neurofilament light levels, a key biomarker for neuronal damage.

Links: * [MediciNova's Clinical Development](https://medicinova.com/clinical-development/core/mn-166/)

• [Phase 1b/2a Clinical Trial in Glioblastoma](https://www.biospace.com/medicinova-announces-data-from-phase-1b-2a-clinical-trial-of-mn-166-ibudilast-in-glioblastoma-patients-at-the-american-society-of-clinical-oncology-asco-annual-meeting-2024)
• [COMBAT-ALS Trial](https://alsnewstoday.com/news/mn-166-ibudilast-slowing-als-progression-trial-data-suggest/)
• [NIH-funded Expanded Access Clinical Trial](https://medicinova.gcs-web.com/news-releases/news-release-details/medicinova-support-nih-funded-expanded-access-clinical-trial)

From Ben Williams Book: Not specified

Loading comments...