Ibudilast

Generic Name: Ibudilast

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₁₈N_₂O

CAS Number: 50847-11-5

Unique Ingredient Identifier: M0TTH61XC5

Background: Ibudilast is an anti-inflammatory and neuroprotective oral agent which shows an excellent safety profile at 60 mg/day and provides significantly prolonged time-to-first relapse and attenuated brain volume shrinkage in patients with relapsing-remitting (RR) and/or secondary progressive (SP) multiple sclerosis (MS). Ibudilast is currently in development in the...

Indication: For the treatment of multiple sclerosis, asthma, and cerebrovascular disease.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS

Conditions: ALS

First Posted Date: 2024-12-20

Last Posted Date: 2024-12-20

Lead Sponsor: Mayo Clinic

Registration Number: NCT06743776

RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine

Phase 2

Recruiting

Conditions: Post Acute Sequelae of COVID-19
Post COVID Condition
Long COVID

Interventions: Other: Placebo
Drug: Ibudilast
Drug: Pentoxifylline

First Posted Date: 2022-08-24

Last Posted Date: 2024-12-06

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 1000

Registration Number: NCT05513560

Locations: 🇨🇦
Mount Sinai Hospital, Toronto, Ontario, Canada
🇨🇦
The Ottawa Hospital, Ottawa, Ontario, Canada
🇨🇦
University Health Network, Osteoporosis Department, Toronto, Ontario, Canada

Ibudilast for Treating Alcohol Use Disorder

Phase 2

Recruiting

Conditions: Alcohol Use Disorder (AUD)
Alcoholism

Interventions: Drug: Ibudilast
Behavioral: Medical management
Drug: Placebo

First Posted Date: 2022-06-10

Last Posted Date: 2024-10-29

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 50

Registration Number: NCT05414240

Locations: 🇺🇸
University of Pennsylvania Center for Studies of Addiction, Philadelphia, Pennsylvania, United States

Regeneration in Cervical Degenerative Myelopathy

Phase 3

Recruiting

Conditions: Myelopathy
Spinal Cord Diseases

Interventions: Drug: Ibudilast
Procedure: Cervical decompressive surgery
Drug: Matching placebo

First Posted Date: 2020-11-17

Last Posted Date: 2022-01-13

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 400

Registration Number: NCT04631471

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, United Kingdom

Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS

Phase 2

Completed

Conditions: Pneumonia, Viral

Interventions: Drug: Ibudilast
Drug: Placebo

First Posted Date: 2020-06-12

Last Posted Date: 2024-10-30

Lead Sponsor: MediciNova

Target Recruit Count: 34

Registration Number: NCT04429555

Locations: 🇺🇸
Denver Health and Hospital Authority, Denver, Colorado, United States
🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States

Ibudilast for the Treatment of Alcohol Use Disorder

Phase 2

Completed

Conditions: Alcohol Use Disorder

Interventions: Drug: Ibudilast
Drug: Placebo oral capsule

First Posted Date: 2018-07-20

Last Posted Date: 2024-11-27

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 102

Registration Number: NCT03594435

Locations: 🇺🇸
UCLA Addictions Laboratory, Los Angeles, California, United States

Ibudilast and Withdrawal-Related Dysphoria

Phase 2

Completed

Conditions: Alcohol Use Disorder

Interventions: Other: Placebo
Drug: Ibudilast

First Posted Date: 2018-04-06

Last Posted Date: 2021-10-07

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 52

Registration Number: NCT03489850

Locations: 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States

Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users

Phase 2

Recruiting

Conditions: Methamphetamine-dependence

Interventions: Drug: Placebo Oral Tablet
Drug: Ibudilast

First Posted Date: 2017-11-14

Last Posted Date: 2024-08-01

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 120

Registration Number: NCT03341078

Locations: 🇺🇸
VA Portland Health Care System, Portland, OR, Portland, Oregon, United States

A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)

Phase 1

Completed

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: Ibudilast

First Posted Date: 2016-03-21

Last Posted Date: 2020-07-21

Lead Sponsor: MediciNova

Target Recruit Count: 35

Registration Number: NCT02714036

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
South Shore Neurologic Associates, P.C., Patchogue, New York, United States

Development of Ibudilast for Alcohol Use Disorder

Phase 1

Completed

Conditions: Alcohol Use Disorders

Interventions: Drug: Ibudilast
Other: Matched placebo

First Posted Date: 2014-01-01

Last Posted Date: 2016-02-23

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 24

Registration Number: NCT02025998

Locations: 🇺🇸
UCLA Addictions Laboratory, Los Angeles, California, United States

Drug Development Updates

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