Clemastine Fumarate

Phase 3Small molecule

Novartis

Clemastine Fumarate is one of 43 small molecule programs targeting Williams syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Williams SyndromeActive, not recruiting

Multiple SclerosisActive, not recruiting

DepressionRecruiting

Multiple Sclerosis (MS)Recruiting

Williams SyndromePhase 2

Active, not recruiting

Multiple SclerosisPhase 3

Active, not recruiting

DepressionPhase 2

Recruiting

Multiple Sclerosis (MS)Preclinical

Recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Clemastine Fumarate

Novartis

Phase 3

2 2

Betaseron

Bayer

Preclinical

16 3

Tysabri

Biogen

Preclinical

14 4

Avonex

EMD Serono

Preclinical

22 5

Flomax

Sanofi

Preclinical

1 6

Myfortic

Novantrone

Pred Forte

Circadin

NNeurim Pharmaceuticals Ltd.

Preclinical

3 10

Pletal

Otsuka

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Depression

NCT06591091

Q2 2027

PreclinicalRecruiting

Multiple Sclerosis (MS)

NCT05359653

Q4 2027

Phase 3Recruiting

Multiple Sclerosis

NCT05338450

Q4 2028

Phase 1/2Not yet recruiting

Acute

NCT06065670

Clinical

Trials by Indication[1]

Multiple Sclerosis2 trials

Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis

Recruiting·AAmsterdam UMC, location VUmc·Phase 3·NCT05338450·80 enrolled

Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT03109288·250 enrolled

Acute1 trial

Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy

Not yet recruiting·UUniversity of California, San Francisco·Phase 1/2·NCT06065670·44 enrolled

CLE1 trial

Effect of Clemastine Fumarate on Color Vision in Healthy Controls

Completed·UUniversity of California, San Francisco·Phase 1·NCT02613091·23 enrolled

Williams syndrome1 trial

Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome

Completed·QQilu Hospital of Shandong University·Phase 2·NCT06315699·28 enrolled

Age1 trial

To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Completed· Novartis logo

Novartis·Phase 1·NCT00913549·36 enrolled

3 more indications

Injury1 trial

An Open-label, Dose-escalation, Phase I/Ib Clinical Trial to Assess the Safety and Pharmacokinetics of Clemastine in Preterm Neonates With White Matter Injury (WRAP)

Not yet recruiting·BBridget LaMonica Ostrem, M.D., Ph.D.·Phase 1·NCT07688746·24 enrolled

Multiple Sclerosis (MS)1 trial

A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Recruiting·UUniversity of California, San Francisco·Preclinical·NCT05359653·74 enrolled

Depression1 trial

Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression

Recruiting·UUniversity of Illinois at Chicago·Phase 2·NCT06591091·80 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Clemastine Fumarate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Clemastine Fumarate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Clemastine Fumarate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

Clemastine Fumarate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Multiple Sclerosis2 trials

Acute1 trial

CLE1 trial

Williams syndrome1 trial

Age1 trial

Injury1 trial

Multiple Sclerosis (MS)1 trial

Depression1 trial

References

Drug Info

Quick Facts

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