Clinical Trials

Numerous Phase I to Phase III clinical trials have evaluated dianhydrogalactitol (VAL-083) in central nervous system malignancies—such as glioblastoma multiforme and malignant glioma—and platinum-resistant ovarian cancer. Sponsored by pharmaceutical companies, academic institutions, and research coalitions, these trials focus on safety, dose escalation, and combination regimens with radiation therapy. Recruitment statuses across these studies range from recruiting, active, and completed to withdrawn and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03970447 RECRUITING
Glioblastoma
Global Coalition for Adaptive Research
 2019-07-30 PHASE2; PHASE3
NCT02717962 COMPLETED
Glioma; Glioblastoma; Glioblastoma Multiforme; GBM; Brain Cancer
Kintara Therapeutics, Inc.
 2017-01-20 PHASE2
NCT03281681 WITHDRAWN
Ovarian Cancer
DelMar Pharmaceuticals, Inc.
 2021-03 PHASE1; PHASE2
NCT03050736 COMPLETED
Glioma; Glioblastoma; Glioblastoma Multiforme; GBM; Brain Cancer
Kintara Therapeutics, Inc.
 2017-12-17 PHASE2
NCT03281681 Withdrawn
Ovarian Cancer
DelMar Pharmaceuticals Inc.|Kintara Therapeutics Inc.
 2021-03 Phase 1|Phase 2
NCT03149575 TERMINATED
Glioblastoma Multiforme; Glioblastoma; Glioma; GBM; Brain Cancer
DelMar Pharmaceuticals, Inc.
 2017-10-27 PHASE3
NCT03050736 Active not recruiting
Glioma|Glioblastoma|Glioblastoma Multiforme|GBM|Brain Cancer
Kintara Therapeutics Inc.|Sun Yat-sen University
 2017-12-17 Phase 2
NCT02717962 Active not recruiting
Glioma|Glioblastoma|Glioblastoma Multiforme|GBM|Brain Cancer
Kintara Therapeutics Inc.
 2017-01-20 Phase 2
NCT01478178 COMPLETED
Glioma; Glioblastoma; Glioblastoma Multiforme; GBM; Brain Cancer
Kintara Therapeutics, Inc.
 2011-10 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-30)

Check the Dianhydrogalactitol (VAL-083) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a bi-functional alkylating agent capable of crossing the blood-brain barrier, dianhydrogalactitol alkylates DNA at N7 positions to form cross-links, thereby disrupting genomic replication and triggering apoptotic cell death in malignant cells. This cytotoxic activity suppresses tumor progression, providing a rationale for its clinical evaluation in glioblastoma multiforme and ovarian cancer.

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.