The clinical evaluation of this compound features a clinical trial focused on assessing therapeutic safety and activity in patients with relapsed or refractory neuroblastoma. Sponsored by collaborative organizations, including the New Approaches to Neuroblastoma Therapy Consortium, SignalRX Pharmaceuticals Inc., and the University of Southern California, this Phase 1 study has been terminated, concluding its early-stage evaluation in this pediatric cancer setting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02337309 | Terminated | Neuroblastoma |
New Approaches to Neuroblastoma Therapy Consortium|SignalRX Pharmaceuticals Inc.|University of Southern California |
2015-07-09 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Check the
LY294002
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- LY294002 Mechanism of Action: PI3K Inhibition in Tumor Cell Research
- LY294002: Selectivity & Specificity
- LY294002 Working Concentration | Cell Culture | Treatment
- LY294002 Solubility in DMSO
- LY294002 Stock Solution
- LY294002 Storage
- LY294002 Stability
- LY294002 Combination Database
- LY294002 Molecular Weight
- LY294002 SMILES
- LY294002 CAS Number
- LY294002 Chemical Structure (2D and 3D)
- LY294002 IC50 for Cell-based and Cell-free Assays
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- LY294002 SDS|MSDS
Note: Technical data last updated: Sep 1, 2026.