Clinical Trials

Numerous clinical trials spanning early to late phases have evaluated marizomib across central nervous system malignancies, solid tumors, and hematologic cancers. Sponsored by industry leaders like Celgene and Secura Bio alongside academic institutions such as Dana-Farber, the National Cancer Institute, and EORTC, these studies yielded variable outcomes. While several clinical trials in solid tumors and glioma reached completion, multiple clinical trials investigating pediatric and adult brain tumors were ultimately terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05050305 WITHDRAWN
Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory
Dana-Farber Cancer Institute
 2024-03 PHASE2
NCT04341311 TERMINATED
Diffuse Intrinsic Pontine Glioma; Pediatric Brainstem Glioma; Pediatric Brainstem Gliosarcoma, Recurrent; Pediatric Cancer; Pediatric Brain Tumor; Diffuse Glioma
Dana-Farber Cancer Institute
 2020-08-10 PHASE1
NCT03463265 COMPLETED
High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma
Aadi Bioscience, Inc.
 2018-08-01 PHASE2
NCT03345095 COMPLETED
Newly Diagnosed Glioblastoma
European Organisation for Research and Treatment of Cancer - EORTC
 2018-07-26 PHASE3
NCT02330562 COMPLETED
Malignant Glioma; Glioblastoma
Celgene
 2015-04-15 PHASE1; PHASE2
NCT03727841 TERMINATED
Anaplastic Ependymoma; Ependymoma; Ependymomas
National Cancer Institute (NCI)
 2020-01-22 PHASE2
NCT02903069 COMPLETED
Glioblastoma; Malignant Glioma
Celgene
 2016-08-17 PHASE1
NCT04341311 Terminated
Diffuse Intrinsic Pontine Glioma|Pediatric Brainstem Glioma|Pediatric Brainstem Gliosarcoma Recurrent|Pediatric Cancer|Pediatric Brain Tumor|Diffuse Glioma
Dana-Farber Cancer Institute|Celgene|Secura Bio Inc.
 2020-08-10 Phase 1
NCT03727841 Terminated
Anaplastic Ependymoma|Ependymoma|Ependymomas
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2020-01-22 Phase 2
NCT02103335 COMPLETED
Multiple Myeloma in Relapse; Refractory Multiple Myeloma; Multiple Myeloma
Celgene
 2014-06-05 PHASE1
NCT02903069 Completed
Glioblastoma|Malignant Glioma
Celgene|Triphase
 2016-08-17 Phase 1
NCT01501396 Withdrawn
Anorexia
Washington University School of Medicine
 2013-09 Phase 2
NCT00667082 COMPLETED
Non-Small Cell Lung Cancer; Pancreatic Cancer; Melanoma; Lymphoma; Multiple Myeloma
Celgene
 2008-03 PHASE1
NCT00667082 Completed
Non-Small Cell Lung Cancer|Pancreatic Cancer|Melanoma|Lymphoma|Multiple Myeloma
Celgene
 2008-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-07-16)

Check the Marizomib (Salinosporamide A) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Marizomib is a marine-derived proteasome inhibitor that potently binds and inhibits the chymotrypsin-like, trypsin-like, and caspase-like catalytic subunits of the 20S proteasome. By suppressing proteasomal degradation of polyubiquitinated proteins, marizomib causes intracellular accumulation of toxic misfolded proteins, thereby triggering apoptosis and inhibiting tumor expansion in brain tumors and solid malignancies evaluated in clinical trials.

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.