Ibudilast

Overview

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 U.S. (codes: AV-411 or MN-166), but is approved for use as an antiinflammatory in Japan.

Indication

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

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS	2024/12/20	NCT06743776	N/A	AVAILABLE	Mayo Clinic
RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine	2022/08/24	NCT05513560	Phase 2	Active, not recruiting	University Health Network, Toronto
Ibudilast for Treating Alcohol Use Disorder	2022/06/10	NCT05414240	Phase 2	Active, not recruiting	University of Pennsylvania
Regeneration in Cervical Degenerative Myelopathy	2020/11/17	NCT04631471	Phase 3	Recruiting	Cambridge University Hospitals NHS Foundation Trust
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS	2020/06/12	NCT04429555	Phase 2	Completed	MediciNova
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS	2019/08/15	NCT04057898	Phase 2	Recruiting	MediciNova
Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers	2019/08/13	NCT04054206	Phase 1	Completed	MediciNova
Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma	2018/12/20	NCT03782415	Phase 1	Completed	MediciNova
Ibudilast for the Treatment of Alcohol Use Disorder	2018/07/20	NCT03594435	Phase 2	Completed	University of California, Los Angeles
Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers	2018/05/23	NCT03533387	Phase 1	Completed	MediciNova

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Ibudilast Sustained Release Tablets	四川杨天生物药业股份有限公司	国药准字H20000423	化学药品	片剂（缓释片）	6/14/2024
Ibudilast Sustained Release Capsules	深圳海王药业有限公司	国药准字H20000412	化学药品	胶囊剂(缓释)	8/5/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Ibudilast Fails to Show Efficacy for Alcohol Use Disorder in Phase 2 Trial, But Shows Promise for Women

a month ago

A UCLA clinical trial found that ibudilast, an asthma drug approved in Japan, was no more effective than placebo for treating alcohol use disorder in most patients.

First Patient Enrolled in NIH-Funded Expanded Access Program for MN-166 in Advanced ALS

3 months ago

MediciNova has enrolled the first patient in an NIH-funded Expanded Access Program trial evaluating MN-166 (ibudilast) in approximately 200 ALS patients who are ineligible for the ongoing Phase 2/3 COMBAT-ALS trial.

MediciNova's Ibudilast Shows Promise in ALS Trial: Interim Analysis Reveals Strong Correlations

7 months ago

MediciNova's COMBAT-ALS Phase 2/3 trial of MN-166 (ibudilast) in ALS shows positive correlations between 6-month and 12-month data for key metrics.

Ibudilast Expanded Access Program for ALS Patients Managed by Widetrial

8 months ago

Widetrial will manage the physician network for an expanded access program (EAP) providing ibudilast (MN-166) to ALS patients ineligible for clinical trials.

MediciNova's Ibudilast (MN-166) Shows Promise in ALS Treatment: Phase 2/3 Trial Update

9 months ago

MediciNova presented an update on its Phase 2/3 COMBAT-ALS trial of MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS) at the 2024 Annual NEALS Meeting.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access