Clinical Trials

Sponsored by Novartis Pharmaceuticals, a Phase I clinical trial is evaluating the oral small-molecule agent IAG933 in adult patients with advanced mesothelioma and other solid tumors. This open-label, multicenter study assesses the safety, pharmacokinetics, and clinical activity of targeting oncogenic Hippo pathway transcription factor interactions. The trial status is currently active, not recruiting, as patient monitoring and evaluation continue.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04857372 ACTIVE_NOT_RECRUITING
Mesothelioma
Novartis Pharmaceuticals
2021-10-21 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-22)

Check the IAG933 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IAG933 acts as a potent small-molecule inhibitor by directly disrupting the interaction between TEAD transcription factors and YAP/TAZ co-activators, thereby preventing downstream transcriptional activation of target oncogenes. This transcriptional blockade suppresses cell proliferation, tumor invasion, and metastatic spread, providing a rationale for inhibiting tumor growth in advanced mesothelioma and other solid tumors with dysregulated Hippo signaling.

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.