Drugs / Ibudilast
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04644003 | Dec 2020 → Jan 2022 | autism spectrum disorder | Stalicla SA | Completed | No outcome recorded |
| Phase 1 | NCT03533387 | Apr → Jul 2018 | — | MediciNova | Completed | No outcome recorded |
| Phase 1 | NCT02025998 | Dec 2013 → Jun 2015 | alcohol-related disorders | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 1 | NCT01389193 | Jun 2013 → Dec 2015 | migraine disorder | Parisa Gazerani | Completed | No outcome recorded |
| Phase 1 | NCT01217970 | Jan 2011 → Mar 2013 | methamphetamine dependence, substance abuse | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03782415 | Dec 2018 → Aug 2023 | glioblastoma | MediciNova | Completed | No outcome recorded |
| Phase 1/2 | NCT02714036 | May 2016 → Dec 2019 | amyotrophic lateral sclerosis | MediciNova | Completed | No outcome recorded |
| Phase 1/2 | NCT01317992 | Apr 2011 → Jun 2013 | — | University of Adelaide | Unknown | No outcome recorded |
| Phase 1/2 | NCT00576277 | Sep 2006 → Nov 2007 | diabetic neuropathy | Avigen | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT04429555 | Jan 2021 → Jun 2022 | viral pneumonia | MediciNova | Completed | No outcome recorded |
| Phase 2 | NCT03594435 | Oct 2018 → Apr 2023 | alcohol-related disorders | University of California, Los Angeles | Completed | Missed primary |
| Phase 2 | NCT02238626 | Sep 2014 → Aug 2017 | amyotrophic lateral sclerosis | MediciNova | Completed | No outcome recorded |
| Phase 2 | NCT01982942 | Nov 2013 → May 2017 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | MediciNova | Completed | Met primary |
| Phase 2 | NCT01860807 | Jul 2013 → Dec 2017 | HIV infectious disease, methamphetamine dependence | University of California, Los Angeles | Completed | Missed primary |
| Phase 2 | NCT00723177 | Oct 2008 → Apr 2010 | substance-related disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05513560 | May 2023 → Mar 2025 | long COVID-19 | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2/3 | NCT04057898 | May 2020 → Apr 2027 expected | amyotrophic lateral sclerosis | MediciNova | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06743776 | — | amyotrophic lateral sclerosis | Mayo Clinic | Available | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT04054206 Comparator | Jun → Jul 2019 | — | MediciNova | Completed | No outcome recorded |
| Phase 2 | NCT05414240 Comparator | Jan 2023 → Dec 2026 expected | alcohol dependence | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03341078 Comparator | May 2019 → Oct 2025 | methamphetamine dependence | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT03489850 Comparator | Jul 2018 → Mar 2020 | alcohol-related disorders | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT01740414 Comparator | Nov 2012 → Dec 2015 | opiate dependence, opioid abuse | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 3 | NCT04631471 Comparator | Dec 2021 → Sep 2026 overdue | spinal cord disorder | Cambridge University Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 62
| Date | Issuer | Release |
|---|---|---|
| 2025-12-08 | MediciNova | Results MediciNova Announces Update and Basic Characteristic Randomized Patients’ of Phase 2/3 Clinical Trial of MN-166 (Ibudilast) in ALS (COMBAT-ALS Clinical Trial) Presented at the 36th International Symposium on ALS/MND medicinova.com ↗
A total of 234 participants were randomized, and enrollment was completed in September 2025. |
| 2024-12-05 | MediciNova | Results MediciNova Presents Study Update and Interim Analysis of Phase 2/3 Clinical Trial of MN-166 (ibudilast) in ALS (COMBAT-ALS Clinical Trial) at the 35th International Symposium on ALS/MND medicinova.com ↗
Positive correlations were observed between the 6-month and 12-month data for CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). |
| 2024-06-03 | MediciNova | Results 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 medicinova.com ↗
The combination of Temozolomide (TMZ) and MN-166 was safe and well tolerated. |
| 2024-03-12 | MediciNova | Results MediciNova Announces New Data and Results of MN-166 (ibudilast) in Chlorine Gas-induced Acute Lung Injury Presented at the 63rd Annual Meeting of the Society of Toxicology medicinova.com ↗
The highlights of the presentation, entitled “Evaluation of safety and pharmacological activity of MN-166 (ibudilast) in a clinically relevant ovine model of chlorine-induced acute lung injury” (Abstract # 4296), are as follows: |
| 2023-11-19 | MediciNova | Results MediciNova Announces New Data and Results of a Phase 2 Clinical Trial of MN-166 (ibudilast) in Glioblastoma Presented at the 28th Annual Meeting of the Society for Neuro-Oncology medicinova.com ↗
MN-166 (ibudilast) and TMZ combination treatment was safe and well-tolerated, and no unexpected adverse effects were reported. |
| 2023-09-27 | MediciNova | Results MediciNova Announces Results of Studies under BARDA Contract to Develop MN 166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury medicinova.com ↗
MediciNova Announces Results of Studies under BARDA Contract to Develop MN 166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury |
| 2023-06-29 | MediciNova | Results MediciNova Announces Presentation of Results from the Phase 2b Trial of MN-166 (ibudilast) in Alcohol Use Disorder at the 46th Annual Research Society on Alcohol (RSA) Scientific Meeting medicinova.com ↗
MN-166 (ibudilast) treatment was not superior to placebo for reducing percent heavy drinking days. |
| 2023-02-20 | MediciNova | Results MediciNova Announces New Data Regarding MN-166 (ibudilast) in Glioblastoma Tumor Tissue Analysis Presented at the 20th Annual World Congress of Society for Brain Mapping and Therapeutics medicinova.com ↗
MediciNova Announces New Data Regarding MN-166 (ibudilast) in Glioblastoma Tumor Tissue Analysis Presented at the 20th Annual World Congress of Society for Brain Mapping and Therapeutics |
| 2023-02-08 | MediciNova | Regulatory MediciNova Announces Health Canada Grants Authorization to Commence Multi-arm Phase 2/3 Clinical Trial to Evaluate MN-166 (ibudilast) in Long COVID medicinova.com ↗
MediciNova Announces Health Canada Grants Authorization to Commence Multi-arm Phase 2/3 Clinical Trial to Evaluate MN-166 (ibudilast) in Long COVID |
| 2023-01-05 | MediciNova | Results MediciNova to Meet with U.S. FDA to Discuss Clinical Development of a Parenteral Formulation of MN-166 (ibudilast) medicinova.com ↗
The trial results yielded encouraging findings as MN-166 (ibudilast) was delivered intravenously to HV with a favorable safety profile and was well tolerated. |
| 2022-12-05 | MediciNova | Results MediciNova Announces Positive Results from Secondary Analysis of Phase 2 Trial of MN-166 (ibudilast) Published in The American Journal of Drug and Alcohol Abuse medicinova.com ↗ |
| 2022-06-08 | MediciNova | Results MediciNova Announces Positive Top-Line Results from Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for Acute Respiratory Distress Syndrome medicinova.com ↗
The trial achieved statistical significance for one of the co-primary endpoints, the proportion of subjects free of respiratory failure. |
| 2022-04-20 | MediciNova | Results MediciNova Announces Publication of MN-166 (ibudilast) Data regarding Prevention of Metastasis in Uveal Melanoma in Molecular Cancer Research medicinova.com ↗
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced data demonstrating that MN-166 (ibudilast) prevents metastasis in a uveal melanoma (UM) animal model was published in the journal Molecular Cancer Research. |
| 2022-01-27 | MediciNova | Regulatory MediciNova Receives a Notice of Intention to Grant for a New Patent Covering MN-166 (ibudilast) for the Treatment of Alcohol Use Disorder in Europe medicinova.com ↗
today announced that it has received a Notice of Intention to Grant from the European Patent Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of alcohol use disorder. |
| 2021-11-10 | MediciNova | Results MediciNova Announces New Data regarding MN-166 (ibudilast) in Uveal Melanoma Presented at the CURE OM Global Science Meeting medicinova.com ↗
UM exosomes induce activation of cell signaling pathways and the release of cytokines and growth factors from hepatocytes. |
| 2021-08-12 | MediciNova | Results MediciNova Reports Second Quarter 2021 Financial Results and Business Update medicinova.com ↗
MediciNova, Inc., (Nasdaq: MNOV, JASDAQ:4875), a biopharmaceutical company developing small-molecule therapeutics, today reported financial results for the second quarter ended June 30, 2021 and provided a business update including results of a safety review from the ongoing Phase 2 trial of MN-166 (ibudilast) in glioblastoma and results from the completed Phase 2 trial of MN-001 (tipelukast) in idiopathic pulmonary fibrosis (IPF). |
| 2021-06-21 | MediciNova | Results MediciNova Announces Positive Results from Phase 2 Trial of MN-166 (ibudilast) in Alcohol Use Disorder Published in Nature’s Translational Psychiatry Journal medicinova.com ↗
today announced that positive results from a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder (AUD) were published in Nature’s Translational Psychiatry. |
| 2020-11-25 | MediciNova | Results MediciNova Announces Positive Optical Coherence Tomography Results from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS Published in Multiple Sclerosis Journal medicinova.com ↗
All OCT measures showed less loss of retinal tissue for MN-166 (ibudilast) compared to placebo. |
| 2020-09-24 | MediciNova | Results MediciNova Announces Positive Clinical Results Regarding MN-166 (ibudilast) for Prevention of Chemotherapy-induced Peripheral Neuropathy Published in Cancer Chemotherapy and Pharmacology medicinova.com ↗
The authors report that co-administration of MN-166 (ibudilast) with oxaliplatin resulted in improvement or stabilization of oxaliplatin-induced neurotoxicity in the majority of participants treated with oxaliplatin. |
| 2020-08-06 | MediciNova | Results MediciNova Announces the Presentation of Positive Results from Phase 2 Trial of MN‑166 (ibudilast) in Alcohol Use Disorder at the American Psychological Association 2020 Annual Convention medicinova.com ↗
Ibudilast significantly reduced the number of heavy drinking days compared to placebo (p=0.03) |
| 2020-07-01 | MediciNova | Regulatory MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19 medicinova.com ↗ |
| 2020-06-25 | MediciNova | Results MediciNova Announces Positive Preclinical Results Regarding MN-166 (ibudilast) in Glioblastoma (GBM) Published in Frontiers in Immunology medicinova.com ↗
In this research publication, in collaboration with Dr. Richard Bucala (Yale University), they report the monocytic subset of MDSCs (M-MDSCs) expressed high levels of the MIF cognate receptor CD74 in the tumor microenvironment. |
| 2019-12-04 | MediciNova | Results MediciNova Announces Additional Analyses from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 30th International Symposium on ALS/MND in Perth, Australia medicinova.com ↗
The results of these analyses indicate that the efficacy of MN-166 is expected to be more robust in patients with a short ALS history. |
| 2019-04-22 | MediciNova | Results MediciNova Announces Results of Subgroup Analysis from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS medicinova.com ↗
MediciNova Announces Results of Subgroup Analysis from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS |
| 2019-04-22 | MediciNova | Results MediciNova Announces the Publication of Results of the Animal Model Study of MN‑166 (ibudilast) in Glioblastoma in Scientific Reports medicinova.com ↗
today announced that Scientific Reports has published results from the animal model study evaluating MN-166 (ibudilast) in glioblastoma (GBM). |
| 2019-04-22 | MediciNova | Regulatory MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS medicinova.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS). |
| 2019-04-02 | MediciNova | Results MediciNova Announces the Presentation of Additional Positive Top-Line Results from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS: Achieved a Statistically Significant 48% Reduction in Whole Brain Atrophy with a Favorable Safety and Tolerability Profile medicinova.com ↗
MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo (p=0.04) as measured by MRI analysis using brain parenchymal fraction (BPF). |
| 2018-10-11 | MediciNova | Regulatory MediciNova Announces FDA Grants Orphan Drug Designation to MN-166 (ibudilast) for Glioblastoma medicinova.com ↗
We are very pleased that the FDA has granted orphan-drug designation for MN-166 as adjunctive therapy to temozolomide for the treatment of GBM, a rare cancer with a high recurrence rate and poor prognosis. |
| 2018-09-14 | MediciNova | Results MediciNova Announces the Publication of Results of the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS in the New England Journal of Medicine medicinova.com ↗
LA JOLLA, Calif., Aug. 29, 2018 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the New England Journal of Medicine has published results of the SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS). |
| 2018-09-14 | MediciNova | Results MediciNova Announces Clinical Data from Subgroup Analyses of Completed Clinical Trial of MN-166 (ibudilast) in ALS medicinova.com ↗
There was a higher percentage of subjects who improved in the MN-166 (ibudilast) group compared to the placebo group. |
| 2018-05-09 | MediciNova | Regulatory MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) in Glioblastoma medicinova.com ↗ |
| 2018-04-26 | MediciNova | Results MediciNova Announces Additional Data from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the American Academy of Neurology (AAN) 70th Annual Meeting medicinova.com ↗
There was a higher rate of responders in the MN-166 (ibudilast) |
| 2018-04-24 | MediciNova | Results MediciNova Announces the Presentation of the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS at the American Academy of Neurology (AAN) 70th Annual Meeting Plenary Session with Additional Imaging Data medicinova.com ↗
A modified per-protocol sensitivity analysis was consistent with findings from the primary analysis (p=0.02) |
| 2018-04-23 | MediciNova | Regulatory MediciNova to Initiate Clinical Trial of MN-166 (ibudilast) in ALS medicinova.com ↗
today announced the FDA approval to initiate a clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS). |
| 2018-04-23 | MediciNova | Results MediciNova Announces Results of Phase 2 Clinical Trial of MN-166 (ibudilast) in Methamphetamine Dependence medicinova.com ↗
There was not an increased rate of serious or severe adverse events in the MN-166 (ibudilast) group compared to the placebo group. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Results from Clinical Trial of MN-166 (ibudilast) in Alcohol Dependence Presented at the 39th Annual Scientific Meeting of the Research Society on Alcoholism in New Orleans, Louisiana medicinova.com ↗
While ibudilast weakened the alcohol-induced rewarding effects described above during the alcohol challenge, it also enhanced a negative reaction (i.e., feeling of tension/anxiety) (p < 0.05) in subjects reporting higher levels of depressive symptomatology on the BDI. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Publication of Positive Findings on MN-166 (ibudilast) in Alcohol Dependence medicinova.com ↗
The article reports that MN-166 (ibudilast) was associated with mood improvements on the stress- and alcohol-cue exposures, as well as reductions in overall craving, depression and anxiety for alcohol in subjects diagnosed with alcohol use disorder (AUD). |
| 2018-04-23 | MediciNova | Results MediciNova Announces Publication of Positive Findings from Completed Phase 1b Clinical Trial of MN-166 (ibudilast) in Methamphetamine Dependence medicinova.com ↗
We are very pleased that the detailed results of the first clinical trial evaluating MN-166 in methamphetamine-dependent subjects have been published. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Presentation of Interim Data from Clinical Trial of MN-166 (ibudilast) in Alcohol Dependence at the 38th Annual RSA (Research Society on Alcoholism) Scientific Meeting medicinova.com ↗
The preliminary results indicate that ibudilast has beneficial effects on mood (p<0.05), decreased the daily measure of alcohol craving (p=0.05), and potentiated alcohol-induced sedation (p<0.05). |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Top-Line Results from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS: Achieved Both Primary Endpoints including a Significant Reduction in Whole Brain Atrophy and Safety and Tolerability medicinova.com ↗
today announced that the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) achieved both primary endpoints. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Top-Line Results from the Clinical Trial of MN-166 (ibudilast) in ALS medicinova.com ↗
LA JOLLA, Calif., Dec. 07, 2017 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive top-line results from MediciNova’s clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS). |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Results from a Glioblastoma Animal Model Study Presented at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois medicinova.com ↗
Proteomics analysis in frozen GBM tissues identified Macrophage Migration Inhibitory Factor (MIF) overexpression in the cells from “poor survivors;” |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Interim Safety Data From Clinical Trial of MN-166 (ibudilast) in ALS medicinova.com ↗
There were no safety or tolerability concerns in the MN-166 (ibudilast) treatment group compared with the placebo treatment group after three months of treatment. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Interim Safety and Clinical Outcomes Data From Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 26th International Symposium on ALS/MND in Orlando, FL medicinova.com ↗
The rate of decline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score, a measure of functional impairment, from Baseline to Month 6 for the MN-166 and placebo subjects combined is below rates observed historically in other ALS studies. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Interim Results of Phase 2a Study of MN-166 (ibudilast) in Opioid Dependence medicinova.com ↗
MN-166 (ibudilast) demonstrated a number of beneficial effects on the subjective, analgesic, and reinforcing effects of oxycodone. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Findings from Completed Trial of MN-166 (ibudilast) in Methamphetamine Dependence Presented at the 50th Winter Conference on Brain Research medicinova.com ↗
Ibudilast decreased levels of the biomarker tumor necrosis factor (TNFα), a pro-inflammatory cytokine, when compared to placebo (p=0.027); |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Findings From a Completed Phase 2 Trial of MN-166 (ibudilast) in Opioid Dependence at the Behavior, Biology and Chemistry: Translational Research in Addiction Meeting in San Antonio, Texas medicinova.com ↗
Sandra Comer, Ph.D., Professor, Department of Psychiatry, Columbia University and New York State Psychiatric Institute (NYSPI), presented results of the completed Phase 2 trial which evaluated MN-166 (ibudilast) in patients with opioid dependence. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Positive Findings From a Clinical Trial of MN-166 (ibudilast) in Alcohol Use Disorder (AUD) Reported at the American College of Neuropsychopharmacology (ACNP)'s 54th Annual Meeting medicinova.com ↗
We are very pleased with the encouraging results reported by Dr. Ray’s research group, particularly ibudilast’s ability to reduce alcohol craving during the study. |
| 2018-04-23 | MediciNova | Results MediciNova Announces New Article Published on MN-166 (ibudilast) in Addiction Biology medicinova.com ↗
The results of this study demonstrate the potential efficacy of MN-166 in the treatment of opioid withdrawal symptoms. |
| 2018-04-23 | MediciNova | Results MediciNova Announces MN-166 (ibudilast) Demonstrated a 26% Reduction in Confirmed Disability Progression in the SPRINT-MS Phase 2b Trial in Progressive MS: Potential Best-in-Disease Drug medicinova.com ↗
MN-166 (ibudilast) demonstrated a 26% reduction in the risk of confirmed disability progression compared to placebo (hazard ratio = 0.74), as measured by EDSS. |
| 2018-04-23 | MediciNova | Results MediciNova Announces Interim Data from Clinical Trial of MN-166 (ibudilast) in ALS Presented at the American Academy of Neurology (AAN) 68th Annual Meeting in Vancouver, Canada medicinova.com ↗
The lower decline in the ALSFRS-R total score in the MN-166 group was driven by lower declines in two ALSFRS-R subscores: the ALSFRS-R Bulbar score and the ALSFRS-R Arm score. |
| 2018-04-23 | MediciNova | Regulatory MediciNova Announces FDA Granted Orphan Drug Designation to MN-166 (ibudilast) for Krabbe Disease medicinova.com ↗
LA JOLLA, Calif., June 3, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) for treatment of Krabbe disease. |
| 2018-04-23 | MediciNova | Regulatory MediciNova Announces FDA Granted Orphan Drug Designation to MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis medicinova.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) for treatment of Amyotrophic Lateral Sclerosis (ALS). |
| 2018-04-23 | MediciNova | Results MediciNova Announces Exploratory Interim Clinical Outcomes Data from Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 27th International Symposium on ALS/MND in Dublin, Ireland medicinova.com ↗
MediciNova Announces Exploratory Interim Clinical Outcomes Data from Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 27th International Symposium on ALS/MND in Dublin, Ireland |
| 2018-04-23 | MediciNova | Results MediciNova Announces Exploratory Interim Clinical Outcomes Data from Clinical Trial of MN-166 (ibudilast) in ALS Presented at the American Academy of Neurology (AAN) 69th Annual Meeting in Boston medicinova.com ↗
Survival rate after open-label period was significantly higher in the group of subjects who completed the entire treatment (i.e., the PP group) than in the group of subjects who withdrew prior to the open-label period (i.e., the ET group p=0.007). |
| 2018-04-23 | MediciNova | Regulatory MediciNova Announces European Medicines Agency Recommends Orphan Medicinal Product Designation for MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis medicinova.com ↗
today announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan-drug) designation for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2018-04-23 | MediciNova | Regulatory MediciNova Announces European Commission Grants Orphan Medicinal Product Designation for MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis medicinova.com ↗
LA JOLLA, Calif., Dec. 20, 2016 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the European Commission has granted Orphan Medicinal Product Designation (OMPD) for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2018-04-23 | MediciNova | Results MediciNova Announces Additional Results from the Completed Trial of MN-166 (ibudilast) in Alcohol Dependence to be Presented at the 39th Annual Scientific Meeting of the Research Society on Alcoholism in New Orleans, Louisiana medicinova.com ↗
Ibudilast increases positive mood and decreases alcohol craving in individuals with AUD |
| 2018-04-23 | MediciNova | Regulatory FDA Grants Rare Pediatric Disease Designation to MediciNova’s MN-166 (ibudilast) for the Treatment of Krabbe Disease medicinova.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to MN-166 (ibudilast) for treatment of Type 1 - Early Infantile Krabbe disease. |
| 2018-04-23 | MediciNova | Regulatory FDA Grants Fast Track Designation for MediciNova's MN-166 (ibudilast) for Progressive Multiple Sclerosis medicinova.com ↗
We are very pleased that MN-166 has received Fast Track Designation for progressive MS and believe this validates its potential to address unmet medical needs for this serious disease. |
| 2018-04-23 | MediciNova | Regulatory FDA Grants Fast Track Designation for MediciNova's MN-166 (ibudilast) for the Treatment of Amyotrophic Lateral Sclerosis medicinova.com ↗
We are very pleased that MN-166 has received Fast Track Designation for ALS and believe this validates its potential to address unmet medical needs in this life-threatening disease. |
| 2018-04-23 | MediciNova | Regulatory FDA Approves a New Clinical Protocol to Evaluate the Effects of MN-166 (ibudilast) on a Biomarker of ALS; MediciNova Plans to Initiate a Clinical Trial with MGH (Massachusetts General Hospital) medicinova.com ↗
FDA Approves a New Clinical Protocol to Evaluate the Effects of MN-166 (ibudilast) on a Biomarker of ALS; MediciNova Plans to Initiate a Clinical Trial with MGH (Massachusetts General Hospital) |
All press releases naming this drug 161 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 161 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ibudilast | “This study aimed to evaluate the safety and tolerability of STP1, a combination of ibudilast and bumetanide, tailored for the treatment of a clinically and biologically defined...” PMID 39062003 ↗ Jun 202416“Ibudilast (MN-166, formerly AV411) is a compound that inhibits the activation of glia.” NCT01740414 ↗ “MN-166 (ibudilast)” NCT06743776 ↗ |
| Known as | AV411 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00576277 ↗ |
| Known as | IBUD | “This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD).” NCT03594435 ↗3“Ibudilast (IBUD) is a macrophage migration inhibitory factor (MIF) and phosphodiesterase (PDE)-4 and -10 inhibitor at peak clinical exposures” NCT01860807 ↗ “Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor.” NCT03489850 ↗ “Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor.” PMID 29794557 ↗ Sep 2018 |
| Known as | ibudilast/AV411 | “ibudilast/AV411” NCT01740414 ↗ |
| Known as | Ketas | ChEMBL registry synonym — accepted as the source's own label CHEMBL19449 ↗ |
| Known as | MN-166 | “Ibudilast (MN-166, formerly AV411) is a compound that inhibits the activation of glia.” NCT01740414 ↗ |
| Action | Inhibit | “The Safety, Tolerability and Preliminary Efficacy of AV411, a Glial Activation Inhibitor, in Heroin Abusers Under Conditions of Morphine Maintenance and Withdrawal” NCT00723177 ↗3“Phosphodiesterase 10A inhibitor” CHEMBL19449 ↗ “Phosphodiesterase 3A inhibitor” CHEMBL19449 ↗ “Phosphodiesterase 5A inhibitor” CHEMBL19449 ↗ |
| Modality | Small molecule | “Ibudilast is a small molecule that crosses the blood-brain barrier after oral administration.” NCT02714036 ↗ |
| Route | Oral | “Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks” NCT00723177 ↗ |
| Target | MIF | “Ibudilast (MN-166) is an inhibitor of macrophage migration inhibitory factor (MIF) and phosphodiesterases 3,4,10 and 11” PMID 34016561 ↗ Apr 2021 |
| Target | PDE10A | “Phosphodiesterase 10A inhibitor” CHEMBL19449 ↗ |
| Target | PDE3A | “Phosphodiesterase 3A inhibitor” CHEMBL19449 ↗ |
| Target | PDE5A | “Phosphodiesterase 5A inhibitor” CHEMBL19449 ↗ |