Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibudilast · 5 trials · 7 indications
Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.
Participants were considered "responders" if they did not meet the need for supplemental oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at the end of the 7-day double-blind treatment.
Number (percentage) of participants with at least a 1-point improvement in clinical status on Day 7. Clinical status is measured by the National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
To evaluate the activity of ibudilast (100 mg/day) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), calculated as the ratio of brain parenchymal tissue volume to the total volume contained within the brain surface contour.
Safety Measures: percentage of participants who experienced treatment-emergent adverse events, clinically significant abnormal laboratory and electrocardiogram results.
Insomnia, Nicotine craving, Gastrointestinal upset, Headache, Musculoskeletal pain, Pain at IV site, Rash, Vivid dreams, Constipation, Dizziness, Dysuria, Ectopic heart beats, Fever/chills/hot flashes, Pruritis, Sore throat, Tinnitus, Backache, Chest congestion, Sedation, or other reported by patient or observed by clinician
Systolic and diastolic blood pressure, heart rate, and an EKG "rhythm strip"
Glial activation will be estimated in eligible participants in the Regular arm by combined magnetic resonance positron emission tomography (MR-PET) using the \[11C\]-PBR28 radioligand. \[11C\]-PBR28 uptake is quantified as the ratio of the standardized uptake value (SUVR). An independent neuroimaging rater blinded to the clinical data will assess for quality control of the PBR28-PET images and SUVR. The primary analysis will be performed on the modified Intent-to-Treat (mITT) population. The median (90% confidence interval \[CI\]) changes from baseline in SUVR from pre- to post-treatment visit will be presented.
Mean change from baseline (pre-dose) to Week 36 in blood biomarkers for neuroinflammation, including macrophage migration inhibitory factor (MIF), tumor necrosis factor (TNF)-alpha, and neurofilament light (NfL). All blood biomarkers are measured in picograms/milliliter (pg/mL).
| Arm | Type | Description |
|---|---|---|
| Ibudilast | EXPERIMENTAL | 10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks |
| Placebo Oral Capsule | PLACEBO_COMPARATOR | matched to experimental drug |
| Active Treatment Group | EXPERIMENTAL | - |
| Placebo Treatment Group | PLACEBO_COMPARATOR | - |
| placebo, Ibudilast 20 mg, then Ibudilast 50mg | EXPERIMENTAL | Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID |
| Ibudilast 20 mg, Ibudilast 50mg, then placebo | EXPERIMENTAL | Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo |
| Regular | EXPERIMENTAL | Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability. |
| Flexible | EXPERIMENTAL | Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans. |
| Name | Type | Description |
|---|---|---|
| Ibudilast | DRUG | targets neurotrophin signaling and neuroimmune function |
| Placebo oral capsule | DRUG | matched to active drug, ibudilast |
| Placebo | DRUG | 0 mg (5 matching capsules) twice daily for 7 days |
| Ibudilast 20mg | DRUG | Ibudilast 20mg BID |
| Ibudilast 50mg | DRUG | Ibudilast 50mg BID |
| Placebo oral tablet | DRUG | - |
Inclusion Criteria: 1. Be between the ages of 18 and 65 2. Meet current (i.e., past 12 months) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for alcohol use disorder moderate or severe 3. Be treatment-seeking for alcohol use disorder (AUD) 4. Report ...
Ibudilast is an investigational small molecule being studied for multiple conditions including viral pneumonia, alcohol use disorder, primary progressive multiple sclerosis, amyotrophic lateral sclerosis, and methamphetamine dependence. It is being developed by MediciNova, Inc. (MNOV) and is currently in Phase 2 clinical development.
Ibudilast is a small molecule that modulates neuroinflammation and glial cell activity. It is believed to inhibit phosphodiesterase enzymes and macrophage migration inhibitory factor, which may reduce inflammatory responses in the central nervous system. This mechanism is being investigated for its potential effects in neurological and psychiatric conditions.
Ibudilast is being developed by MediciNova, Inc., a biopharmaceutical company traded under the ticker symbol MNOV. The company is conducting clinical trials to evaluate the drug for various indications including progressive multiple sclerosis, alcohol use disorder, and viral pneumonia.
Ibudilast is in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in progressive multiple sclerosis, alcohol use disorder, and viral pneumonia. The drug is investigational and has not been approved by regulatory authorities for any indication.
Ibudilast has been evaluated in several completed clinical trials. NCT01982942 studied it in 255 patients with progressive multiple sclerosis. NCT03594435 examined its effects in 102 patients with alcohol use disorder. NCT04429555 tested it in 34 patients hospitalized with COVID-19 at risk for ARDS. NCT01217970 was a Phase 1 safety interaction trial in methamphetamine-dependent individuals.
Yes, Ibudilast is also known as MN-166. The drug is being developed by MediciNova, Inc. under this designation. Clinical trials have used both names to refer to the same investigational compound.