Clinical Trials

Multiple clinical trials sponsored predominantly by industry entities, including Merck KGaA and EMD Serono, evaluate evobrutinib across Phase 1, Phase 2, and Phase 3 development. These studies assess the compound's pharmacokinetics, safety, and efficacy in neuroinflammatory and autoimmune disorders—such as relapsing multiple sclerosis and rheumatoid arthritis—along with cohorts of healthy volunteers and individuals with renal or hepatic impairment. Although numerous early-phase trials have been completed, certain advanced Phase 3 investigations have been terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04338022 TERMINATED
Relapsing Multiple Sclerosis
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2020-06-12 PHASE3
NCT04338061 TERMINATED
Relapsing Multiple Sclerosis
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2020-07-02 PHASE3
NCT07214935 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2022-11-08 PHASE1
NCT07214922 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2023-01-18 PHASE1
NCT05245396 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2022-02-02 PHASE1
NCT07215806 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2022-08-24 PHASE1
NCT05248945 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2022-01-13 PHASE1
NCT05248945 Completed
Healthy
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
 2022-01-13 Phase 1
NCT05064488 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2021-10-04 PHASE1
NCT04546789 COMPLETED
Hepatic Impairment
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2020-09-30 PHASE1
NCT04697511 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2021-01-11 PHASE1
NCT04546789 Completed
Hepatic Impairment
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
 2020-09-30 Phase 1
NCT04314024 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2020-05-25 PHASE1
NCT04032171 TERMINATED
Relapsing-remitting Multiple Sclerosis
EMD Serono Research & Development Institute, Inc.
 2019-09-10 PHASE3
NCT04314024 Completed
Healthy
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
 2020-05-25 Phase 1
NCT04032158 TERMINATED
Relapsing-remitting Multiple Sclerosis
EMD Serono Research & Development Institute, Inc.
 2019-08-26 PHASE3
NCT03233230 COMPLETED
Rheumatoid Arthritis
EMD Serono Research & Development Institute, Inc.
 2017-09-18 PHASE2
NCT03934502 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2019-04-15 PHASE1
NCT03934502 Completed
Healthy
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
 2019-04-15 Phase 1
NCT03436394 COMPLETED
Renal Impairment
Merck KGaA, Darmstadt, Germany
 2018-03-21 PHASE1
NCT03725072 COMPLETED
Healthy
Merck KGaA, Darmstadt, Germany
 2018-10-30 PHASE1
NCT02975349 TERMINATED
Relapsing-remitting Multiple Sclerosis
EMD Serono Research & Development Institute, Inc.
 2017-03-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-06-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Evobrutinib functions as a highly selective Bruton's tyrosine kinase inhibitor with an IC50 of 37.9 nM that binds to BTK to block B-cell receptor signaling cascades, thereby inhibiting B-cell activation and proinflammatory cytokine production. This targeted cellular suppression diminishes immune-mediated inflammatory responses, demonstrating therapeutic potential in autoantibody-driven and neuroinflammatory diseases such as relapsing multiple sclerosis and rheumatoid arthritis.

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>).

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Note: Technical data last updated: Sep 1, 2026.