BIIB021 Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 547

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Biogen have evaluated the pharmacological profile and therapeutic efficacy of BIIB021 in conditions including advanced solid tumors, breast cancer, gastrointestinal stromal tumors (GIST), and B-cell chronic lymphocytic leukemia. These studies assessed safety, dose escalation, pharmacokinetics, pharmacodynamic activity, and combination therapies with agents such as exemestane. Recruitment statuses across these clinical trials primarily encompass completed and terminated evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01004081	COMPLETED	Breast Cancer	Biogen	2009-11	PHASE2
NCT01017198	COMPLETED	Advanced Solid Tumors	Biogen	2009-11	PHASE1
NCT00618735	COMPLETED	Advanced Solid Tumors	Biogen	2008-02	PHASE1
NCT00618319	COMPLETED	GIST	Biogen	2008-02	PHASE2
NCT01017198	Completed	Advanced Solid Tumors	Biogen	2009-11	Phase 1
NCT01004081	Completed	Breast Cancer	Biogen	2009-11	Phase 2
NCT00344786	TERMINATED	B-Cell Chronic Lymphocytic Leukemia	Biogen	2006-02	PHASE1
NCT00618735	Completed	Advanced Solid Tumors	Biogen	2008-02	Phase 1
NCT00618319	Completed	GIST	Biogen	2008-02	Phase 2

(data from https://clinicaltrials.gov, updated on 2015-10-02)

Check the BIIB021 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BIIB021 competitively binds to the ATP-binding pocket of heat shock protein 90 (HSP90), preventing chaperone activity and triggering the degradation of critical oncogenic client proteins including HER2, AKT, and Raf-1 while upregulating HSP70 and HSP27. This targeted disruption of oncogenic survival signaling inhibits cellular proliferation and induces apoptosis, ultimately impairing tumor growth in patients with advanced solid tumors, breast cancer, and gastrointestinal stromal tumors.

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>).