Clinical Trials

Multiple clinical trials investigate conditions including adult bronchiectasis, smoldering multiple myeloma, and multiple myeloma bone disease across Phase 1, Phase 2, and observational study designs. Sponsored by academic entities such as the University of Dundee and industry partners including Novartis Pharmaceuticals, these studies evaluate disease endotyping, treatment response, and dose determination. Reflecting broader research in respiratory and hematologic disorders, the trials exhibit recruitment statuses ranging from actively recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03791086 Recruiting
Bronchiectasis Adult
University of Dundee
 2019-11-01 --
NCT01302886 Completed
Smoldering Multiple Myeloma
Novartis Pharmaceuticals|Novartis
 2011-05 Phase 2
NCT00741377 Completed
Multiple Myeloma Bone Disease
Novartis Pharmaceuticals|Novartis
 2009-01 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

BHQ selectively binds to and inhibits sarco-endoplasmic reticulum Ca2+-ATPase (SERCA), blocking ATP-dependent calcium reuptake into the endoplasmic reticulum and causing persistent cytosolic calcium elevation that triggers cellular stress and apoptosis. This perturbation of intracellular calcium homeostasis provides therapeutic potential for controlling pathological cell survival and inflammation in clinical conditions such as multiple myeloma and adult bronchiectasis.

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.