Remibrutinib Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

Numerous clinical trials across Phase 1 through Phase 3 are currently evaluating remibrutinib for autoimmune, allergic, and chronic inflammatory conditions, including chronic spontaneous urticaria, relapsing multiple sclerosis, hidradenitis suppurativa, Sjögren syndrome, and peanut allergy. Led by pharmaceutical sponsors like Novartis Pharmaceuticals alongside academic institutions such as Washington University School of Medicine, these studies display recruitment statuses ranging from actively recruiting to completed and terminated. Collectively, these initiatives highlight the broad clinical advancement of this targeted therapeutic agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07456891	RECRUITING	Indication of the Parent Protocol	Novartis Pharmaceuticals	2026-04-16	PHASE3
NCT07665437	RECRUITING	Hidradenitis Suppurativa	Novartis Pharmaceuticals	2026-07-10	PHASE3
NCT07225504	RECRUITING	Secondary Progressive Multiple Sclerosis (SPMS)	Novartis Pharmaceuticals	2025-11-11	PHASE3
NCT07222956	NOT_YET_RECRUITING	Multiple Sclerosis (MS) - Relapsing-remitting; Multiple Sclerosis (MS) Secondary Progressive; Multiple Sclerosis (MS) Primary Progressive	Moein Amin	2027-03-01	PHASE2
NCT07700056	NOT_YET_RECRUITING	Chronic Pruritus of Unknown Origin	Novartis Pharmaceuticals	2026-08-14	PHASE3
NCT06846281	RECRUITING	Relapsing Multiple Sclerosis	Novartis Pharmaceuticals	2025-06-23	PHASE3
NCT07768371	RECRUITING	IgE-Mediated Food Allergy; Peanut Allergy; Cow Milk Allergy; Egg Allergy	Novartis Pharmaceuticals	2026-08-27	PHASE3
NCT06744920	RECRUITING	Generalized Myasthenia Gravis	Novartis Pharmaceuticals	2025-02-07	PHASE3
NCT07681271	RECRUITING	Papulopustular Rosacea	Novartis Pharmaceuticals	2026-07-30	PHASE2
NCT06865651	RECRUITING	Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)	Novartis Pharmaceuticals	2025-05-22	PHASE2
NCT06840392	ACTIVE_NOT_RECRUITING	Hidradenitis Suppurativa	Novartis Pharmaceuticals	2025-03-20	PHASE3
NCT06799000	ACTIVE_NOT_RECRUITING	Hidradenitis Suppurativa	Novartis Pharmaceuticals	2025-01-31	PHASE3
NCT06868212	RECRUITING	Chronic Spontaneous Urticaria (CSU)	Novartis Pharmaceuticals	2025-07-11	PHASE3
NCT05677451	ACTIVE_NOT_RECRUITING	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2023-07-11	PHASE3
NCT05156281	ACTIVE_NOT_RECRUITING	Relapsing Multiple Sclerosis	Novartis Pharmaceuticals	2021-12-13	PHASE3
NCT05147220	ACTIVE_NOT_RECRUITING	Relapsing Multiple Sclerosis	Novartis Pharmaceuticals	2021-12-16	PHASE3
NCT05976243	ACTIVE_NOT_RECRUITING	Chronic Inducible Urticaria	Novartis Pharmaceuticals	2023-12-07	PHASE3
NCT07032272	COMPLETED	Autoimmune and Chronic Inflammatory Diseases	Novartis Pharmaceuticals	2025-07-23	PHASE1
NCT06042478	ACTIVE_NOT_RECRUITING	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2023-11-15	PHASE3
NCT05432388	COMPLETED	Allergy, Peanut	Novartis Pharmaceuticals	2022-10-12	PHASE2
NCT05513001	ACTIVE_NOT_RECRUITING	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2022-12-09	PHASE3
NCT05795153	COMPLETED	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2023-04-05	PHASE3
NCT05030311	COMPLETED	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2021-11-30	PHASE3
NCT05032157	COMPLETED	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2021-12-01	PHASE3
NCT05753592	COMPLETED	Hepatic Impairment	Novartis Pharmaceuticals	2022-10-31	PHASE1
NCT05048342	COMPLETED	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals	2022-01-15	PHASE3
NCT05677451	Recruiting	Chronic Spontaneous Urticaria	Novartis Pharmaceuticals\|Novartis	2023-07-11	Phase 3
NCT05432388	Recruiting	Allergy Peanut	Novartis Pharmaceuticals\|Novartis	2022-10-12	Phase 2
NCT05156281	Recruiting	Relapsing Multiple Sclerosis	Novartis Pharmaceuticals\|Novartis	2021-12-13	Phase 3
NCT05147220	Recruiting	Relapsing Multiple Sclerosis	Novartis Pharmaceuticals\|Novartis	2021-12-16	Phase 3
NCT04035668	TERMINATED	Sjögren Syndrome	Novartis Pharmaceuticals	2019-07-12	PHASE2
NCT04035668	Terminated	Sjögren Syndrome	Novartis Pharmaceuticals\|Novartis	2019-07-12	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Remibrutinib acts as a highly selective covalent inhibitor that binds to an inactive conformation of Bruton's tyrosine kinase (BTK), thereby potently suppressing BTK-dependent downstream signaling pathways, including FcγR-mediated IL-8 release and B-cell receptor-stimulated CD69 expression. By preventing immune cell activation and the release of pro-inflammatory mediators, this targeted inhibition provides potential therapeutic benefit in managing autoimmune and inflammatory conditions such as chronic spontaneous urticaria and multiple sclerosis.

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>).