Clinical Trials

Several clinical trials are evaluating zotiraciclib across Phase 1 and Phase 1/2 studies for solid tumors and hematological malignancies, including glioblastoma, astrocytoma, IDH1/2-mutated malignant gliomas, acute myeloid leukemia, and multiple myeloma. Sponsored by both pharmaceutical entities such as Tragara Pharmaceuticals Inc. and public institutions like the National Cancer Institute and the National Institutes of Health Clinical Center, these protocols display varying recruitment statuses ranging from completed and terminated to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05588141 RECRUITING
Brain Tumor; Cancer
National Cancer Institute (NCI)
 2023-05-16 PHASE1; PHASE2
NCT05588141 Recruiting
Brain Tumor|Cancer
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2023-05-16 Phase 1|Phase 2
NCT02942264 TERMINATED
Brain Tumor; Astrocytoma; Astroglioma; Glioblastoma; Gliosarcoma
National Cancer Institute (NCI)
 2016-12-14 PHASE1; PHASE2
NCT02942264 Completed
Brain Tumor|Astrocytoma|Astroglioma|Glioblastoma|Gliosarcoma
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2016-12-14 Phase 1|Phase 2
NCT01204164 Completed
AML|ALL|Blast Crisis|MDS|Multiple Myeloma
Tragara Pharmaceuticals Inc.
 2010-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zotiraciclib functions as a potent small-molecule inhibitor of cyclin-dependent kinases (CDK1, CDK2, and CDK9), JAK2, and FLT3, disrupting key transcriptional elongation pathways and downstream signal transduction to induce apoptotic cell death. By suppressing tumor cell proliferation and survival signals, this multi-target mechanism provides the biological basis for its evaluation in clinical trials for glioblastoma and hematological malignancies.

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.