Clinical Trials

Multiple clinical trials sponsored by Fujifilm Pharmaceuticals U.S.A. Inc. have evaluated FF-10101 in adult patients diagnosed with acute myeloid leukemia. These completed Phase I and Phase I/II studies assessed the drug's safety, tolerability, pharmacokinetics, and initial efficacy. Together, these investigations establish the early clinical evaluation framework for this compound in relapsed or refractory hematologic malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03194685 COMPLETED
AML, Adult
Fujifilm Pharmaceuticals U.S.A., Inc.
 2017-05-05 PHASE1
NCT03194685 Completed
AML Adult
Fujifilm Pharmaceuticals U.S.A. Inc.
 2017-05-05 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-12-24)

Check the FF-10101 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FF-10101 acts as a novel, irreversible inhibitor that covalently binds both wild-type and mutant FMS-like tyrosine kinase 3 (FLT3), thereby potently suppressing downstream oncogenic signal transduction and inducing apoptotic cell death in leukemic cells. By shutting down FLT3-mediated survival signaling pathways, this targeted activity inhibits leukemic blast proliferation, offering therapeutic potential for adult acute myeloid leukemia driven by wild-type or resistant FLT3 mutations.

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.