Clinical Trials

Several clinical trials have evaluated ENMD-2076 across various therapeutic indications in oncology. Sponsored by CASI Pharmaceuticals Inc., these completed Phase 1 studies assessed safety, pharmacokinetics, and preliminary activity in patients with advanced cancer, multiple myeloma, and relapsed or refractory hematological malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00904787 Completed
Relapsed or Refractory Hematological Malignancies
CASI Pharmaceuticals Inc.
 2009-04 Phase 1
NCT00806065 Completed
Multiple Myeloma
CASI Pharmaceuticals Inc.
 2008-12 Phase 1
NCT00658671 Completed
Advanced Cancer
CASI Pharmaceuticals Inc.
 2008-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the ENMD-2076 L-(+)-Tartaric acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ENMD-2076 L-(+)-Tartaric acid selectively binds to and inhibits Aurora A kinase and FLT3 with IC50 values of 14 nM and 1.86 nM, respectively, exhibiting significantly higher selectivity over Aurora B and related receptor tyrosine kinases. By blocking downstream signaling pathways essential for mitotic spindle assembly and cell survival, the compound triggers cell cycle arrest and apoptosis, which suppresses tumor progression in patients with advanced cancer, multiple myeloma, and relapsed or refractory 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.