Clinical Trials

Multiple clinical trials evaluate ibudilast across Phase 1, Phase 2, and Phase 1/2 protocols for indications including glioblastoma, amyotrophic lateral sclerosis, methamphetamine dependence, opioid-related disorders, diabetic neuropathy, and healthy volunteers. Sponsored by biopharmaceutical entities such as MediciNova and Avigen alongside government bodies like the National Institute on Drug Abuse and the VA Office of Research and Development, these studies encompass completed, recruiting, and active, non-recruiting protocols, including a clinical trial evaluating combination therapy for glioblastoma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04054206 Completed
Healthy Volunteers
MediciNova
 2019-06-24 Phase 1
NCT03341078 Recruiting
Methamphetamine-dependence
VA Office of Research and Development|Portland VA Medical Center|Oregon Health and Science University
 2019-05-01 Phase 2
NCT03782415 Active not recruiting
Glioblastoma|Recurrent Glioblastoma|GBM|Newly Diagnosed Glioblastoma
MediciNova
 2018-12-29 Phase 1|Phase 2
NCT02714036 Completed
Amyotrophic Lateral Sclerosis
MediciNova|Massachusetts General Hospital|South Shore Neurologic Associates
 2016-05-06 Phase 1|Phase 2
NCT00723177 Completed
Opioid-Related Disorders
New York State Psychiatric Institute|National Institute on Drug Abuse (NIDA)
 2008-10 Phase 2
NCT00576277 Completed
Diabetic Neuropathy
Avigen
 2006-09 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Ibudilast product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ibudilast functions as a non-selective phosphodiesterase inhibitor that suppresses cyclic nucleotide breakdown, leading to elevated intracellular cAMP levels, inhibition of pro-inflammatory cytokine release, and reduced neuroglial activation. This attenuation of neuroinflammatory cascades and glial-mediated neurotoxicity provides a clear rationale for its clinical evaluation in conditions such as glioblastoma, amyotrophic lateral sclerosis, and neuropathic pain.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.