Clinical Trials

Several Phase I and Phase II clinical trials evaluating Rosiglitazone HCl have investigated pharmacokinetic drug interactions in healthy volunteers alongside conditions such as non-small cell lung cancer, erectile dysfunction, renal cell carcinoma, and papillary, follicular, and Huerthle cell thyroid cancers. Sponsored by academic and corporate entities including Sun Yat-sen University, Vanda Pharmaceuticals, VIVUS LLC, Exelixis, and FibroGen, the recruitment status across these studies is designated as completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02737709 Terminated
Non-small Cell Lung Cancer
Sun Yat-sen University
 2016-03 Phase 2
NCT01402076 Completed
Healthy Volunteers
Vanda Pharmaceuticals
 2011-08 Phase 1
NCT01415128 Completed
Erectile Dysfunction
VIVUS LLC
 2010-04 Phase 1
NCT01100619 Completed
Papillary Thyroid Cancer|Follicular Thyroid Cancer|Huerthle Cell Thyroid Cancer|Renal Cell Carcinoma
Exelixis
 2010-04 Phase 1
NCT01376063 Completed
Healthy Adult Subjects
FibroGen
 2010-03 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rosiglitazone HCl selectively binds to peroxisome proliferator-activated receptors (PPAR) in adipose cells, thereby modulating downstream transcriptional pathways to increase cellular glucose uptake and insulin sensitivity. This metabolic modulation alters cellular homeostasis, providing a rationale for investigating its pharmacological effects and drug-drug interactions in clinical trial settings involving non-small cell lung cancer, solid tumors, and renal cell carcinoma.

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.