Fenebrutinib (GDC-0853) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Fenebrutinib has been evaluated in multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 studies sponsored primarily by Hoffmann-La Roche and Genentech Inc., with recruitment statuses including recruiting, active not recruiting, completed, and terminated. These studies target healthy participants, hematologic malignancies such as chronic lymphocytic leukemia and diffuse large B-cell lymphoma, and autoimmune conditions including multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, and chronic urticaria. Additionally, several clinical trials focus on late-phase evaluations in relapsing multiple sclerosis, primary progressive multiple sclerosis, and urticaria.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07161258	RECRUITING	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2025-10-06	PHASE2
NCT04586010	ACTIVE_NOT_RECRUITING	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2021-03-17	PHASE3
NCT04544449	ACTIVE_NOT_RECRUITING	Multiple Sclerosis, Primary Progressive	Hoffmann-La Roche	2020-10-26	PHASE3
NCT04586023	ACTIVE_NOT_RECRUITING	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2021-03-24	PHASE3
NCT05119569	ACTIVE_NOT_RECRUITING	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2022-03-01	PHASE2
NCT01991184	COMPLETED	Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma	Genentech, Inc.	2013-12-16	PHASE1
NCT05119569	Active not recruiting	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2022-03-01	Phase 2
NCT04586023	Active not recruiting	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2021-03-24	Phase 3
NCT04586010	Active not recruiting	Relapsing Multiple Sclerosis	Hoffmann-La Roche	2021-03-17	Phase 3
NCT03407482	TERMINATED	Lupus Erythematosus, Systemic	Genentech, Inc.	2018-01-09	PHASE2
NCT03693625	TERMINATED	Urticaria	Genentech, Inc.	2018-09-27	PHASE2
NCT03137069	COMPLETED	Urticaria	Genentech, Inc.	2017-05-26	PHASE2
NCT02983227	COMPLETED	Rheumatoid Arthritis	Genentech, Inc.	2016-11-30	PHASE2
NCT02908100	COMPLETED	Systemic Lupus Erythematosus	Genentech, Inc.	2017-01-19	PHASE2
NCT03290703	COMPLETED	Healthy Volunteers	Genentech, Inc.	2017-04-18	PHASE1
NCT03693625	Terminated	Urticaria	Genentech Inc.	2018-09-27	Phase 2
NCT03596632	COMPLETED	Healthy Participants	Hoffmann-La Roche	2018-07-27	PHASE1
NCT02833350	COMPLETED	Rheumatoid Arthritis	Genentech, Inc.	2016-09-09	PHASE2
NCT03596632	Completed	Healthy Participants	Hoffmann-La Roche	2018-07-27	Phase 1
NCT03188783	COMPLETED	Healthy Volunteer	Hoffmann-La Roche	2017-01-24	PHASE1
NCT03174041	COMPLETED	Healthy Participants	Genentech, Inc.	2017-04-18	PHASE1
NCT02699710	COMPLETED	Healthy Volunteer	Genentech, Inc.	2015-09-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-11)

Check the Fenebrutinib (GDC-0853) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fenebrutinib selectively binds to Bruton's tyrosine kinase in a non-covalent manner, blocking downstream B-cell receptor and Fc receptor-mediated signaling pathways. This enzymatic inhibition suppresses B-cell activation, proliferation, and proinflammatory mediator release, providing the biological mechanism for evaluating its clinical efficacy in autoimmune conditions such as multiple sclerosis and systemic lupus erythematosus.

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>).