Clinical Trials

Multiple clinical trials are currently investigating this compound across Phase 1, Phase 2, and Phase 4 protocols for indications including multiple myeloma, obstructive sleep apnea, blood pressure variability, and primary total knee arthroplasty. Predominantly sponsored by academic and medical institutions, such as University Hospital Heidelberg, National Jewish Health, Cedars-Sinai Medical Center, and Wake Forest University Health Sciences, these investigations feature recruitment statuses ranging from completed studies to protocols that are not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07097493 NOT_YET_RECRUITING
Knee Arthroplasty, Total
Wake Forest University Health Sciences
2027-02 PHASE4
NCT06012487 NOT_YET_RECRUITING
Blood Pressure Variability
Cedars-Sinai Medical Center
2026-05-01 PHASE1
NCT02314858 COMPLETED
Obstructive Sleep Apnea (OSA)
National Jewish Health
2014-10-01
NCT02237261 COMPLETED
Multiple Myeloma
University Hospital Heidelberg
2014-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a potent inhibitor of PTEN with an IC50 of 14 nM, bpV (HOpic) selectively binds the PTEN active site and suppresses its lipid phosphatase activity, thereby blocking the conversion of phosphatidylinositol 3,4,5-trisphosphate to phosphatidylinositol 4,5-bisphosphate and increasing intracellular levels of PIP3. This accumulating PIP3 triggers constitutive downstream AKT phosphorylation and cellular survival signaling, which alters growth regulatory phenotypes and provides mechanistic context for target modulation in conditions such as multiple myeloma.

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>).

Note: Technical data last updated: Sep 1, 2026.