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Clemastine

Phase 1

Multiple Sclerosis (MS) | Small molecule | Immunology |United Therapeutics Corporation|Last Updated: Mar 11, 2026

Target and mechanism

Molecular targetHRH1
Target classAntagonist
ModalitySmall molecule

Also known as Clemastine Fumarate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

Clemastine · 1 trial · 7 indications

Phase 1 1
NCT05359653Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair TherapyMultiple Sclerosis (MS)
RECRUITING74 Analytics
PHASE1RECRUITING
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
Multiple Sclerosis (MS)Unlock trial analytics

Study Endpoints

Primary Endpoints

Corpus Callosum Myelin Water Fraction
This will be assessed at the baseline visit.

The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum.

Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months
This will be assessed at the baseline and 3-month visits.

The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)

Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months
This will be assessed at the baseline and 6-month visits.

The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)

Corpus Callosum T1 Relaxation Time
This will be assessed at the baseline visit.

The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI.

Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months
This will be assessed at the baseline and 3-month visits.

The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (3-month time - Baseline time)

Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 Months
This will be assessed at the baseline and 6-month visits.

The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (6-month time - Baseline time)

Corpus Callosum UTE Fraction
This will be assessed at the baseline visit.

The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum.

Change from Baseline in Corpus Callosum UTE Fraction at 3 Months
This will be assessed at the baseline and 3-month visits.

The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)

Change from Baseline in Corpus Callosum UTE Fraction at 6 Months
This will be assessed at the baseline and 6-month visits.

The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)

Secondary Endpoints

Optic Radiation Myelin Water Fraction
This will be assessed at the baseline visit.
Change from Baseline in Optic Radiation Myelin Water Fraction at 3 Months
This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic Radiation Myelin Water Fraction at 6 Months
This will be assessed at the baseline and 6-month visits.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Clemastine 8 mg, then PlaceboEXPERIMENTALGroup 1 will receive the treatment (clemastine 8mg/day) for the first 90 days and then switch to the placebo (a sugar pill) for the remaining 90 days
Placebo, then Clemastine 8 mgEXPERIMENTALGroup 2 will receive the placebo (a sugar pill) for the first 90 days and then switch to the treatment (clemastine 8mg/day) for the remaining 90 days

Interventions

NameTypeDescription
Clemastine FumarateDRUG8 mg Clemastine tablet. Clemastine fumarate was approved by the Food and Drug Administration (FDA) for the treatment of allergic rhinitis (seasonal allergies) in 1977 and was approved for over-the-counter marketing in 1992. Clemastine is not FDA approved as a remyelinating therapy
PlaceboDRUGMatched sugar tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written informed consent must be obtained prior to any assessment being performed. * Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of \< 15 years * Male or female patients aged 18-55 years (inclusive) * Use of appropriate contraception d...

Countries:United States
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Frequently asked questions about Clemastine

What is Clemastine used for in Multiple Sclerosis?

Clemastine is an investigational small molecule being studied for the treatment of Multiple Sclerosis (MS). It is currently in Phase 1 clinical development, with a focus on assessing its potential as a myelin repair therapy in MS patients.

What does Clemastine target?

Clemastine is a small molecule being investigated for its potential to promote myelin repair in Multiple Sclerosis. The specific molecular target of Clemastine in this context has not been disclosed in the available information.

Who makes Clemastine?

Clemastine is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol UTHR.

What phase is Clemastine in?

Clemastine is currently in Phase 1 clinical development for Multiple Sclerosis. It is an investigational drug and has not yet been approved by regulatory authorities.

What clinical trials is Clemastine in?

Clemastine is being evaluated in a Phase 1 clinical trial with the identifier NCT05359653. This randomized, double-blind, controlled study is assessing changes in multi-parametric MRI in MS patients taking Clemastine Fumarate as a myelin repair therapy.

Is Clemastine the same as Clemastine Fumarate?

Yes, Clemastine is also known as Clemastine Fumarate. The clinical trial NCT05359653 specifically evaluates Clemastine Fumarate as a myelin repair therapy in patients with Multiple Sclerosis.