Clinical Trials

Numerous clinical trials evaluate clemastine fumarate across Phase 1 to Phase 3, primarily focusing on demyelinating conditions—including relapsing-remitting, primary progressive, and chronic progressive multiple sclerosis—alongside allergic dermatitis, depression, internuclear ophthalmoplegia, and neurodevelopmental delay in Williams syndrome. Led by academic and healthcare organizations including the University of California San Francisco, the University of Cambridge, the University of Illinois at Chicago, and Azidus Brasil, key Phase 2 evaluations investigate remyelination efficacy. Across the field, protocol recruitment statuses encompass completed, recruiting, active, and terminated trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06065670 NOT_YET_RECRUITING
Demyelinating Diseases; Demyelination; Corpus Callosum; Multiple Sclerosis Brain Lesion; Multiple Sclerosis Acute and Progressive; Clinically Isolated Syndrome, CNS Demyelinating
University of California, San Francisco
 2026-09-15 PHASE1; PHASE2
NCT02521311 RECRUITING
Optic Neuritis
University of California, San Francisco
 2017-02-28 PHASE2
NCT07304024 RECRUITING
Central Auditory Processing Disorder; Hearing Impaired (Partially); Hearing; Hearing Abnormality; Hearing Disability; Hearing Disorder; Hearing Disorders; Hearing Impairment, Sensorineural; Hearing Handicap; Hearing Impaired; Hearing Impairment; Hearing Loss; Central Auditory Disease; Noise Exposure; Noise Induced Hearing Loss; Noise-Induced Hearing Loss; Sound Perception; Myelin Degeneration; Myelinopathy; Myelin Integrity; Remyelination; Hidden Hearing Loss; Cocktail Party Skill; Cocktail Party Syndrome; CAPD; Age Problem
University of Colorado, Denver
 2025-03-31 PHASE1; PHASE2
NCT07688746 RECRUITING
White Matter Injury; Brain Injury, Fetus and Neonate; Neonatal Brain Injury; Periventricular Leukomalacia; Periventricular White Matter Abnormalities
Bridget LaMonica Ostrem, M.D., Ph.D.
 2026-07-26 PHASE1
NCT05359653 RECRUITING
Multiple Sclerosis (MS); Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis Relapse; Multiple Sclerosis Brain Lesion; Multiple Sclerosis Benign
University of California, San Francisco
 2023-08-01 PHASE1; PHASE2
NCT06591091 RECRUITING
Depression
University of Illinois at Chicago
 2025-12-10 PHASE2
NCT06315972 NOT_YET_RECRUITING
Schizophrenia
LMU Klinikum
 2024-04 PHASE2
NCT06087757 ACTIVE_NOT_RECRUITING
Williams Syndrome
Sheba Medical Center
 2024-04-01 PHASE2
NCT05338450 TERMINATED
Multiple Sclerosis; Internuclear Ophthalmoplegia
Amsterdam UMC, location VUmc
 2022-08-30 PHASE3
NCT05131828 COMPLETED
Multiple Sclerosis
Cambridge University Hospitals NHS Foundation Trust
 2022-03-08 PHASE2
NCT06315699 COMPLETED
Williams Syndrome; Child; Neurodevelopmental Delay
Qilu Hospital of Shandong University
 2024-03-20 PHASE2
NCT06065670 Not yet recruiting
Demyelinating Diseases|Demyelination; Corpus Callosum|Multiple Sclerosis Brain Lesion|Multiple Sclerosis Acute and Progressive|Clinically Isolated Syndrome CNS Demyelinating
University of California San Francisco
 2024-03-01 Phase 1|Phase 2
NCT05359653 Recruiting
Multiple Sclerosis (MS)|Multiple Sclerosis Relapsing-Remitting|Multiple Sclerosis Primary Progressive|Multiple Sclerosis Chronic Progressive|Multiple Sclerosis Relapse|Multiple Sclerosis Brain Lesion|Multiple Sclerosis Benign
University of California San Francisco|United States Department of Defense
 2023-08-01 Phase 1|Phase 2
NCT05131828 Recruiting
Multiple Sclerosis
Cambridge University Hospitals NHS Foundation Trust|University of Cambridge
 2022-03-08 Phase 2
NCT03826004 COMPLETED
Efficacy and Safety
Chinese Academy of Medical Sciences, Fuwai Hospital
 2019-02-20
NCT02613091 COMPLETED
Healthy Subjects
University of California, San Francisco
 2016-04 PHASE1
NCT02040298 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
University of California, San Francisco
 2014-01 PHASE2
NCT02040298 Completed
Multiple Sclerosis Relapsing-Remitting
University of California San Francisco
 2014-01 Phase 2
NCT01257061 COMPLETED
Eczema
EMS
 2012-09-06 PHASE3
NCT01239719 UNKNOWN
Allergy; Dermatitis
Azidus Brasil
 2011-03 PHASE3
NCT01239719 Unknown status
Allergy|Dermatitis
Azidus Brasil
 2011-03 Phase 3
NCT01125761 WITHDRAWN
Dermatitis
Azidus Brasil
 2010-11 PHASE3
NCT00481676 COMPLETED
Chronic Urticaria
Novartis
 2007-05 PHASE2
NCT00913549 COMPLETED
Allergy
Sandoz
 1989-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-11)

Check the Clemastine (HS-592) Fumarate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clemastine fumarate selectively binds to and inhibits the histamine H1 receptor with an IC50 of 3 nM, while also modulating mTOR signaling to stimulate autophagic pathways. This targeted suppression of histamine-mediated downstream signaling and enhancement of cellular remyelination provide therapeutic relief from allergic responses and promote neural repair in demyelinating disorders such as 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>).

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