Catadegbrutinib (BGB-16673) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Catadegbrutinib (BGB-16673) is being evaluated across several clinical trials spanning Phase 1 through Phase 3 to investigate its safety, efficacy, combination regimens, and drug-interaction profiles. Research primarily focuses on B-cell malignancies—including chronic lymphocytic leukemia, various lymphomas, and Waldenström macroglobulinemia—alongside autoimmune conditions such as chronic spontaneous urticaria and pharmacokinetic studies in healthy volunteers. Sponsored by pharmaceutical entities like BeiGene and BeOne Medicines alongside academic institutions including Massachusetts General Hospital and M.D. Anderson Cancer Center, recruitment statuses across these protocols range from recruiting and active to completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07508995	NOT_YET_RECRUITING	Chronic Lymphocytic Leukemia (CLL)	M.D. Anderson Cancer Center	2026-09-01	PHASE2
NCT06970743	ACTIVE_NOT_RECRUITING	Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma	BeOne Medicines	2025-05-29	PHASE3
NCT05294731	RECRUITING	B-cell Malignancy; Non-Hodgkin Lymphoma; Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Waldenström Macroglobulinemia; Marginal Zone Lymphoma; Follicular Lymphoma; DLBCL Unclassifiable; Richter's Transformation	BeiGene	2022-05-06	PHASE1; PHASE2
NCT06634589	RECRUITING	B-cell Malignancy; Relapsed Cancer; Refractory Cancer; B-cell Lymphoma	BeOne Medicines	2024-11-27	PHASE1; PHASE2
NCT06846671	RECRUITING	CLL; Chronic Lymphocytic Leukemia	BeOne Medicines	2025-04-10	PHASE3
NCT06973187	RECRUITING	Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma	BeOne Medicines	2025-09-04	PHASE3
NCT06849713	RECRUITING	Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma (SLL)	Massachusetts General Hospital	2025-05-16	PHASE2
NCT05006716	RECRUITING	B-cell Malignancy; Marginal Zone Lymphoma; Follicular Lymphoma; Non-Hodgkin Lymphoma; Waldenström Macroglobulinemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma	BeOne Medicines	2021-09-13	PHASE1; PHASE2
NCT07005713	COMPLETED	Chronic Spontaneous Urticaria	BeiGene	2025-07-19	PHASE1
NCT06906809	COMPLETED	Healthy Volunteers	BeiGene	2025-04-03	PHASE1
NCT06776679	COMPLETED	Healthy Volunteers	BeiGene	2025-01-24	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the Catadegbrutinib (BGB-16673) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Catadegbrutinib (BGB-16673) selectively targets Bruton's tyrosine kinase (BTK) to drive proteasomal degradation, thereby ablating downstream B-cell receptor signaling and associated oncogenic survival cascades. This targeted protein elimination suppresses aberrant B-cell proliferation and promotes apoptosis, underlying its clinical evaluation for therapeutic efficacy in patients with B-cell malignancies such as chronic lymphocytic leukemia and non-Hodgkin lymphomas.

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>).