Multiple clinical trials evaluate HSP990 across oncology and neurodegenerative disease indications. Early-stage Phase 1 dose-escalation studies sponsored by Novartis Pharmaceuticals previously investigated oral administration in patients with advanced solid malignancies, resulting in completed and terminated statuses. Furthermore, academic institutions, including Universitaire Ziekenhuizen KU Leuven, are currently recruiting participants for an observational study utilizing [11C]HSP990 as a novel PET radioligand to quantify brain Hsp90 in Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07380204 | RECRUITING | Parkinson's Disease (PD); Alzheimer's Disease (AD); Amyotrophic Lateral Sclerosis (ALS) |
Universitaire Ziekenhuizen KU Leuven |
2024-09-04 | |
| NCT00879905 | COMPLETED | Advanced Solid Malignancies |
Novartis Pharmaceuticals |
2009-05 | PHASE1 |
| NCT01064089 | TERMINATED | Advanced Solid Tumors |
Novartis Pharmaceuticals |
2010-02 | PHASE1 |
| NCT00879905 | Completed | Advanced Solid Malignancies |
Novartis Pharmaceuticals|Novartis |
2009-05 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-02-02)
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>).
- HSP990 (NVP-HSP990) Solubility in DMSO
- HSP990 (NVP-HSP990) Stock Solution
- HSP990 (NVP-HSP990) Storage
- HSP990 (NVP-HSP990) Stability
- HSP990 (NVP-HSP990) Molecular Weight
- HSP990 (NVP-HSP990) SMILES
- HSP990 (NVP-HSP990) CAS Number
- HSP990 (NVP-HSP990) Chemical Structure (2D and 3D)
- HSP990 (NVP-HSP990) SDS|MSDS