Clinical Trials

Several completed Phase 1 and Phase 2 clinical trials, sponsored by Novartis Pharmaceuticals, evaluated the safety, tolerability, pharmacodynamics, and clinical efficacy of BFH772 formulations. These proof-of-concept studies investigated early-stage therapeutic applications for inflammatory dermatological and arthritic disorders, specifically psoriasis, arthritis, and erythemato-telangiectatic rosacea. Together, they established the initial clinical profile of BFH772 across targeted inflammatory and vascular skin indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01449591 COMPLETED
Erythemato-telangiectatic Rosacea
Novartis Pharmaceuticals
2011-09 PHASE2
NCT00987870 COMPLETED
Psoriasis; Arthritis
Novartis Pharmaceuticals
2009-09 PHASE1; PHASE2
NCT00987870 Completed
Psoriasis|Arthritis
Novartis Pharmaceuticals|Novartis
2009-09 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2021-02-21)

Check the BFH772 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BFH772 functions as a potent small-molecule inhibitor that selectively binds to vascular endothelial growth factor receptor 2 (VEGFR2) with an IC50 of 3 nM, thereby blocking receptor autophosphorylation and downstream pro-angiogenic signaling cascades. By suppressing endothelial cell proliferation, migration, and capillary tube formation, this inhibition reduces pathological neovascularization and vascular hyperpermeability associated with chronic inflammatory conditions such as psoriasis, arthritis, and erythemato-telangiectatic rosacea.

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.