CysLT1 antagonists(Cysteinyl leukotriene receptor 1 antagonists), PDE3 inhibitors(Phosphodiesterase 3 inhibitors), PDE4 inhibitors(Phosphodieterase 4 inhibitors)

+ [1]

Therapeutic Areas

Immune System DiseasesNervous System DiseasesCardiovascular Diseases+ [7]

Active Indication

Cerebrovascular DisordersAsthmaCerebral Hemorrhage+ [13]

Inactive Indication

Brain InjuriesCerebral ArteriosclerosisChemotherapy-induced damage+ [11]

Originator Organization

KYORIN Pharmaceutical Co., Ltd.

Active Organization

VA Office of Research and Development

MediciNova, Inc.

University of Pennsylvania

+ [3]

Inactive Organization

The New York State Psychiatric Institute

Avigen, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (01 Jan 1989),

Cerebral Arteriosclerosis

RegulationOrphan Drug (EU)

Structure

Molecular FormulaC14H18N2O

InChIKeyZJVFLBOZORBYFE-UHFFFAOYSA-N

CAS Registry50847-11-5

Clinical Trials associated with Ibudilast

NCT05513560 / RecruitingPhase 2/3IIT

REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)

The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 ("Long COVID"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Because this is an adaptive trial, arms can be dropped if found to be ineffective and new arms can be added.
Interventions will last for 2 months and participants will be followed for an additional 4 months (6 months total). Approximately 800-1000 patients with Long COVID will be recruited across Canada. Results from this trial will accelerate the availability of high-quality, real-time evidence and solutions to enable Canada to improve the clinical care of patients with Long COVID.

Start Date31 May 2023

Sponsor / Collaborator

University Health Network

NCT05414240 / RecruitingPhase 2IIT

A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder

This is a research study involving 6 weeks of study medication, Ibudilast or a placebo (an inactive substance) and medical management counseling to reduce or stop drinking. Ibudilast is not approved by the U.S. FDA for clinical use in the United States, but it is has been used for many years in Japan for its anti-inflammatory effects. Its use in the treatment of alcohol dependence is experimental. By reducing inflammation, Ibudilast may help some people reduce or stop drinking. We have obtained an Investigational New Drug Application (IND) approval for this study from the FDA. Ibudilast has been used clinically for 20 years in Asia for treating bronchial asthma and, more recently, for post-stroke dizziness and ocular allergies and has been shown to be safe and well tolerated.

Start Date14 Jan 2023

Sponsor / Collaborator

University of Pennsylvania

NCT04631471 / RecruitingPhase 3IIT

Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy

Degenerative (wear and tear arthritis of the spine) Cervical (concerning the neck) Myelopathy (injury to the spinal cord), DCM, is the most common spinal cord disorder of adulthood. In DCM, arthritis of the spine causes compression of the spinal cord.
The symptoms of DCM are often mistaken for natural consequences of ageing, including numb and clumsy hands, loss of coordination, imbalance, bladder and bowel problems. The weakness can progress to severe paralysis. Every year approximately 4 individuals in 100,000 undergo surgery for DCM; however, many more individuals are thought to suffer from DCM.
The main treatment for DCM is surgery. The aim of surgery is to create space and remove the compression of the spinal cord. This is known to prevent further injury. Unfortunately, the post-operative improvements are often incomplete and many patients remain severely disabled. Improving outcome after surgery represents an important unmet clinical need.
Clinical and preclinical findings indicate that the drug Ibudilast can stimulate neuroprotective and regenerative processes in the spinal cord. Ibudilast is well-tolerated and used to treat asthma and post-stroke dizziness in Japan and is currently being investigated for use in treating other neurological diseases.
This study will investigate whether daily oral administration of Ibudilast for a maximum of 34 weeks can improve hand function, strength, balance, urinary problems and reduce pain.
The study will initially be conducted at three sites in the UK, with more sites added as necessary. Individuals between 18-80 years old, diagnosed with DCM and scheduled for an operation for the first time will be invited to participate in the trial. The study will entail patient questionnaires and clinical assessments before surgery, shortly after surgery and 3, 6, and 12 months after surgery. Moreover, patients will undergo MRI scans pre-operatively and at 6-months postoperatively to determine whether the treatment was successful.

Start Date22 Dec 2021

Sponsor / Collaborator

Cambridge University Hospitals NHS Foundation Trust

100 Clinical Results associated with Ibudilast

100 Translational Medicine associated with Ibudilast

100 Patents (Medical) associated with Ibudilast

238

Literatures (Medical) associated with Ibudilast

01 Sep 2024·Genes & Genomics

Actn2 defects accelerates H9c2 hypertrophy via ERK phosphorylation under chronic stress

Article

Author: Chen, Peng ; Sheng, Mingchen ; Yu, Youjia ; Wang, Ye ; Wu, Jiayi ; Hu, Li ; Huang, Shuainan ; Wang, Jie ; Chen, Feng ; Wang, Kang ; Han, Xing ; Wan, Hua

BACKGROUNDIn humans, ACTN2 mutations are identified as highly relevant to a range of cardiomyopathies such as DCM and HCM, while their association with sudden cardiac death has been observed in forensic cases. Although ACTN2 has been shown to regulate sarcomere Z-disc organization, a causal relationship between ACTN2 dysregulation and cardiomyopathies under chronic stress has not yet been investigated.OBJECTIVEIn this work, we explored the relationship between Actn2 dysregulation and cardiomyopathies under dexamethasone treatment.METHODSPrevious cases of ACTN2 mutations were collected and the conservative analysis was carried out by MEGA 11, the possible impact on the stability and function of ACTN2 affected by these mutations was predicted by Polyphen-2. ACTN2 was suppressed by siRNA in H9c2 cells under dexamethasone treatment to mimic the chronic stress in vitro. Then the cardiac hypertrophic molecular biomarkers were elevated, and the potential pathways were explored by transcriptome analysis.RESULTSActn2 suppression impaired calcium uptake and increased hypertrophy in H9c2 cells under dexamethasone treatment. Concomitantly, hypertrophic molecular biomarkers were also elevated in Actn2-suppressed cells. Further transcriptome analysis and Western blotting data suggested that Actn2 suppression led to the excessive activation of the MAPK pathway and ERK cascade. In vitro pharmaceutical intervention with ERK inhibitors could partially reverse the morphological changes and inhibit the excessive cardiac hypertrophic molecular biomarkers in H9c2 cells.CONCLUSIONOur study revealed a functional role of ACTN2 under chronic stress, loss of ACTN2 function accelerated H9c2 hypertrophy through ERK signaling. A commercial drug, Ibudilast, was identified to reverse cell hypertrophy in vitro.

02 May 2024·Expert Opinion on Pharmacotherapy

Promising immunomodulators for management of substance and alcohol use disorders

Review

Author: Park, Connor ; Acuña, Amanda M ; Olive, M Foster ; Leyrer-Jackson, Jonna M

INTRODUCTIONThe neuroimmune system has emerged as a novel target for the treatment of substance use disorders (SUDs), with immunomodulation producing encouraging therapeutic benefits in both preclinical and clinical settings.AREAS COVEREDIn this review, we describe the mechanism of action and immune response to methamphetamine, opioids, cocaine, and alcohol. We then discuss off-label use of immunomodulators as adjunctive therapeutics in the treatment of neuropsychiatric disorders, demonstrating their potential efficacy in affective and behavioral disorders. We then discuss in detail the mechanism of action and recent findings regarding the use of ibudilast, minocycline, probenecid, dexmedetomidine, pioglitazone, and cannabidiol to treat (SUDs). These immunomodulators are currently being investigated in clinical trials described herein, specifically for their potential to decrease substance use, withdrawal severity, central and peripheral inflammation, comorbid neuropsychiatric disorder symptomology, as well as their ability to improve cognitive outcomes.EXPERT OPINIONWe argue that although mixed, findings from recent preclinical and clinical studies underscore the potential benefit of immunomodulation in the treatment of the behavioral, cognitive, and inflammatory processes that underlie compulsive substance use.

01 May 2024·Alcohol, Clinical and Experimental Research

Sex differences in neural response to an acute stressor in individuals with an alcohol use disorder

Article

Author: Belnap, Malia ; Kirsch, Dylan ; Grodin, Erica N ; Ray, Lara A

AbstractBackgroundAlcohol use disorder (AUD) and stress influence overlapping neural circuits in the brain. The literature is mixed regarding the presence of sex differences in the neural response to acute stressors, and this issue has not been examined in individuals with AUD. We validated a stress functional magnetic resonance imaging (fMRI) paradigm in individuals with AUD and tested for sex differences.MethodsTwenty‐five treatment‐seeking individuals with AUD (15M/10F) were recruited to participate in the neuroimaging study linked to a clinical trial of ibudilast (NCT03594435). To assess social‐evaluative stress, participants completed the Montreal Imaging Stress Task (MIST). Whole brain and amygdala region‐of‐interest analyses were conducted. Subjective ratings of anxiety and distress were collected. Repeated measures ANCOVAs were performed to evaluate the effect of stress on anxiety and distress and to evaluate sex differences.ResultsThere were trend‐level effects of stress on anxiety ratings and amygdala activation (p's = 0.06). There was a significant effect of stress in the bilateral thalamus, ventral tegmental area, and paracingulate (Z's > 4.09, p's < 0.03). There was a trend‐level effect of sex on subjective ratings of stress (p's = 0.07). Females had higher amygdala activation in response to stress (p = 0.02). Females also had greater activation than males in the precuneus, posterior cingulate cortex, and right inferior frontal gyrus during acute stress (Z's > 3.56, p's < 0.03).ConclusionsThis study provides an initial validation of the MIST in a sample of individuals with AUD. It also provides preliminary evidence of sex differences in the response to social‐evaluative stress, which is important, given the relevance of stress and negative emotionality as motivators for alcohol use in females.

News (Medical) associated with Ibudilast

03 Sep 2024

·www.biospace.com

MediciNova Announces Acceptance of Abstract Regarding MN-166 (ibudilast) in COMBAT-ALS Clinical Trial for Presentation at the 2024 Annual NEALS (Northeast Amyotrophic Lateral Sclerosis Consortium) Meeting

LA JOLLA, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that an abstract was accepted for presentation regarding a clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS), COMBAT-ALS Phase 2b/ 3 study at the 2024 Annual NEALS Meeting to be held October 21-24, 2024 (a hybrid meeting in Clearwater, Florida and Online). The presentation will be in poster format and be presented by lead Principal Investigator of the clinical trial, Björn Oskarsson, MD, FAAN, Associate Professor of Neurology at Jacksonville, FL and Director, ALS Center of Excellence. The presentation details are as follows: Submission ID : 164 Title : COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Study Design and Trial Update Session : Poster Presentation Date : October 23 rd , 2024 About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety pro MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in metabolic-associated fatty liver disease (MAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT : David H. Crean, Ph.D. Chief Business Officer MediciNova, Inc info@medicinova.com

Phase 2

29 Aug 2024

·www.globenewswire.com

MediciNova Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Covering MN-166 (ibudilast) for the Post-COVID Condition

LA JOLLA, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application, which covers MN-166 (ibudilast) for post-COVID conditions. The Method of Use patent covers administering a therapeutically effective doses of ibudilast (or a pharmaceutically acceptable salt thereof) to alleviate a range of post-COVID conditions including anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, sleep difficulties, hair loss, and rash. The claim method allows for MN-166 (ibudilast) to be administered alone or in combination with other active agents, including corticosteroids, NSAIDs, SSRIs, and more. The allowed claims cover oral administration, intravenous administration, subcutaneous injection, intramuscular injection, and inhalation administration. The allowed claims cover a wide range of doses, a range of different dosing frequencies, and a range of different treatment periods. Once issued, this patent is expected to expire no earlier than November 2042. Kazuko Matsuda, M.D., Ph.D., M.P.H., MediciNova’s Chief Medical Officer commented, “This additional patent for ibudilast provides additional opportunities for us to maintain exclusivity in areas where research is underway. We remain dedicated to addressing the complex and persistent health challenges posed by COVID-19 through key partnerships, such as our current collaboration with University Health Network in Canada, where a Phase 2/3 clinical trial in Long COVID is ongoing. We believe that ibudilast may offer hope to millions of patients suffering from post-COVID conditions, providing a versatile and effective therapeutic option. Since we have committed to move forward to apply New Drug Application when the study shows positive outcome, we plan to initiate the discussion with Health Canada when the RECLAIM study shows the positive data.” About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Phase 3

28 Jun 2024

·www.globenewswire.com

STALICLA publishes pioneering phase 1b data on precision treatment for autism spectrum disorder in Biomedicines

STALICLA’s precision psychiatry study highlights strong EEG-based target engagement of STP1 treatment in defined subgroup of patients with autism and numerical improvement in core symptoms June 27, 2024 – STALICLA SA, a Swiss neuro precision biotech company dedicated to developing precision medicine-based treatments for neuropsychiatric and neurodevelopmental disorders, today announced the publication of a landmark phase 1b study with STP1, a novel combination therapy tailored for the treatment of a clinically and biologically defined subgroup of patients with autism spectrum disorder (ASD), named ASD Phenotype 1 (ASD-Phen1). The results of the study were published in the peer-reviewed journal Biomedicines, in an article titled “Safety, Tolerability, and EEG-Based Target Engagement of STP1 (PDE3,4 Inhibitor and NKCC1 Antagonist) in a Randomized Clinical Trial in a Subgroup of Patients with ASD”. Lynn Durham, CEO of STALICLA, highlighted: “This study marks a significant milestone in the advancement of precision medicine for ASD. It is a first-of-its-kind stratification-based approach for clinical development in neurodevelopmental disorders, demonstrating the potential of precision medicine in ASD.” The randomized, double-blind, placebo-controlled phase 1b clinical trial evaluated the safety and tolerability of STP1, a combination of ibudilast and bumetanide, in ASD-Phen1 patients. The clinical trial (registered at clinicaltrials.gov NCT04644003), involved two 14-day treatment phases of ASD-Phen1 patients receiving STP1 or placebo. The results showed that STP1 was well-tolerated with no significant adverse effects reported. Significant and dose-related reductions in gamma power were observed in the whole brains of patients taking STP1, particularly in regions associated with executive function and memory. Additionally, STP1 increased alpha 2 power in frontal and occipital regions, while improving habituation and neural synchronization to auditory chirps. Dr. Craig A. Erickson, Associate Professor, UC Department of Psychiatry and Behavioral Neuroscience, Cincinnati Children’s Hospital Medical Center, and the principal investigator of the study, remarked: “The electrophysiological signals from this study are remarkable and represent the strongest early trial target engagement signals our lab has seen in the autism field.” Dr. Laura Pérez-Cano, Head of Discovery at STALICLA and co-author of the study, added: “These findings not only highlight the potential of STP1 as a therapeutic option for ASD-Phen1 patients but also underscore the importance of combining biologically-based patient stratification with quantifiable outcome measures such as EEG that can then be correlated with behavioral measures.” By focusing on a biologically defined subgroup of ASD patients, STALICLA is moving closer to making personalized treatment options a reality for patients with ASD. This approach has the potential to revolutionize the treatment of ASD and other neuropsychiatric conditions. STALICLA is a global, clinical-stage biotechnology company focused on advancing precision medicine for brain disorders. The company has developed a unique neuro precision development platform, DEPI, supported by clinical validation in a first indication: Autism Spectrum Disorder. Its lead neurodevelopmental disorder asset, STP1, is entering Phase 2 trials. Its lead neuropsychiatry asset, STP7 (Mavoglurant), fully funded by the US government, will soon be Phase 3 ready for Cocaine Use Disorder. ‎ The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

100 Deals associated with Ibudilast

External Link

KEGG	Wiki	ATC	Drug Bank
D01385	Ibudilast	R03DC04	DB05266

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cerebrovascular Disorders	KR	-	19 Sep 2002
Asthma	JP	KYORIN Pharmaceutical Co., Ltd.	17 Jan 1989
Cerebral Hemorrhage	JP	KYORIN Pharmaceutical Co., Ltd.	17 Jan 1989

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cervical myelopathy	Phase 3	-	MediciNova, Inc.	01 Mar 2022
Amyotrophic Lateral Sclerosis	Phase 3	US	MediciNova, Inc.	28 May 2020
Amyotrophic Lateral Sclerosis	Phase 3	CA	MediciNova, Inc.	28 May 2020
Spinal Cord Diseases	Phase 3	GB	MediciNova, Inc.	16 Aug 2019
Opioid-Related Disorders	Phase 3	US	-	20 Oct 2008
Diabetic Neuropathies	Phase 3	AU	Avigen, Inc.	01 Sep 2006
Diabetic Neuropathies	Phase 3	AU	Avigen, Inc.	01 Sep 2006
Headache	Phase 3	AU	MediciNova, Inc.	-
Neuralgia	Phase 2	AU	MediciNova, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03782415 (ASCO2024) Manual	Phase 1/2	Glioblastoma CD74 expression	62	Ibudilast+temozolomide (newly diagnosed GBM (nGBM))	(omntdtyzfo) = Ibudilast 50 mg BID tqlwitfkod (hbqvyoazap )	Positive	24 May 2024
				Ibudilast+temozolomide (recurrent GBM (rGBM))
GlobeNewswire Manual	Phase 2	Glioblastoma First line	62	MN-166+temozolomide	-	Positive	19 Nov 2023
				MN-166+temozolomide (newly diagnosed GBM)	(ywglneppcy) = jcvyajtdlr wfbepcibhr (ckizsfvtaf )
ACTRIMS2023	Not Applicable	-	-	Ibudilast	(oyznwbukqv) = lrgtcwpqga hvoanuddxj (mtipmqrqup ) View more	-	30 May 2023
				Placebo	(oyznwbukqv) = zkdlhipmri hvoanuddxj (mtipmqrqup ) View more
NCT04429555 (Corporate Publications) Manual	Phase 2	COVID-19 \| Respiratory Distress Syndrome, Adult	34	MN-166	(owlopwmtto) = iuhcdfnesg jjwgxlhknj (gpmeuzigxf ) View more	Positive	08 Jun 2022
				Placebo	(owlopwmtto) = alcbtnosva jjwgxlhknj (gpmeuzigxf ) View more
NCT02238626 (IBU-ALS-1201, CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	70	MN-166+riluzole (MN-166)	qreppopsyn(ilrucwbbfc) = abrbaqihfu ofdqektwpy (pewvwhiuhh, ujmkijjjzd - yyvwhigfjc) View more	-	05 Nov 2021
				Placebo (for MN-166)+riluzole (Placebo (for MN-166))	ynmsgihnum(crkkmnckof) = srsertfbjf suktkzztzh (edxizlhqya, vckeibrxvq - crkuoqixxf)
SPRINT-MS (ECTRIMS2021)	Phase 2	Multiple Sclerosis, Chronic Progressive	-	Ibudilast	byatsfbkjp(wkyyhxyhmp) = knwzqwozgk aitnqopemc (uimyupevnk, 0.20)	-	12 Oct 2021
				Placebo	byatsfbkjp(wkyyhxyhmp) = mfzakkrgnc aitnqopemc (uimyupevnk, 0.20)
NCT03489850 (CTgov)	Phase 2	Alcohol Use Disorder	52	Ibudilast (Ibudilast)	fmxndzodwz(ennmzmcqwv) = hjrizuhibi spxllrnqog (sbqdbupemd, gufmjgabed - rslorndssg) View more	-	07 Oct 2021
				Placebo (Placebo)	fmxndzodwz(ennmzmcqwv) = efkejnuotc spxllrnqog (sbqdbupemd, zmsewukznd - phvkbmmuuz) View more
NCT03489850 (Pubmed \| Transl Psychiatry) Manual	Phase 2	Alcohol Use Disorder	52	ibudilast	pdxxiseskj(ajrwigtngf): P-Value = 0.62 View more	Positive	12 Jun 2021
				Placebo
NCT02714036 (Pubmed \| Neuroimage Clin) Manual	Phase 1/2	Amyotrophic Lateral Sclerosis	30	Ibudilast	(lcnxubrkwm) = lkbdjdayhv bmieicsvvj (pgrajsfckf ) View more	Positive	01 Jan 2021
NCT01982942 (SPRINT-MS, Pubmed \| Mult Scler)	Phase 2	Multiple Sclerosis, Chronic Progressive	255	Ibudilast	pmuhddslwp(orihsnmsvm) = qupvcbxtle cjhpqsrave (udleuaxegp, -0.02693 to 0.01688) View more	-	15 Oct 2020
				Placebo	pmuhddslwp(orihsnmsvm) = tfjorqklzu cjhpqsrave (udleuaxegp, -0.05824 to -0.01494) View more

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