Clinical Trials

Multiple clinical trials evaluate the small-molecule CDK inhibitor fadraciclib (CYC065) across early phase 1, phase 1, and phase 1/2 studies sponsored primarily by Cyclacel Pharmaceuticals, Inc. alongside institutions like Gustave Roussy. These investigations assess monotherapy and combination regimens in healthy subjects for pharmacokinetic evaluation, advanced solid tumors, pediatric cancers, and hematologic malignancies, including leukemia, myelodysplastic syndrome, acute myeloid leukemia, and refractory chronic lymphocytic leukemia. Trial recruitment statuses encompass completed, active not recruiting, recruiting, and suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02813135 RECRUITING
Pediatric Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2016-08-03 PHASE1; PHASE2
NCT04983810 UNKNOWN
Solid Tumor, Adult; Lymphoma
Cyclacel Pharmaceuticals, Inc.
 2021-07-12 PHASE1; PHASE2
NCT05168904 SUSPENDED
Leukemia; Myelodysplastic Syndrome(MDS)
Cyclacel Pharmaceuticals, Inc.
 2021-10-22 PHASE1; PHASE2
NCT05817890 COMPLETED
Healthy
Cyclacel Pharmaceuticals, Inc.
 2023-03-03 EARLY_PHASE1
NCT05817890 Active not recruiting
Healthy
Cyclacel Pharmaceuticals Inc.
 2023-03-03 Early Phase 1
NCT04017546 COMPLETED
AML; MDS
Cyclacel Pharmaceuticals, Inc.
 2019-08-02 PHASE1
NCT03739554 COMPLETED
Relapsed or Refractory Chronic Lymphocytic Leukemia
Cyclacel Pharmaceuticals, Inc.
 2019-01-25 PHASE1
NCT02552953 COMPLETED
Cancer
Cyclacel Pharmaceuticals, Inc.
 2015-09-28 PHASE1
NCT02552953 Completed
Cancer
Cyclacel Pharmaceuticals Inc.
 2015-09-28 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-10)

Check the Fadraciclib (CYC065) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fadraciclib (CYC065) acts as an ATP-competitive inhibitor targeting cyclin-dependent kinases 2 and 9 (CDK2/CDK9), thereby disrupting kinase-mediated phosphorylation events and downstream transcriptional cell-survival signaling pathways. The resulting induction of cell cycle arrest and apoptotic cell death provides the mechanistically driven rationale for its clinical investigation in hematologic malignancies such as leukemia and myelodysplastic syndrome as well as advanced solid tumors.

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.