NDAORALTABLET
Approved
Aug 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
TAVIST-1 (clemastine fumarate) by GSK is clinical pharmacology clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. First approved in 1992.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAVIST-1 (clemastine fumarate) is an oral first-generation antihistamine indicated for allergic conditions. It works by competitively blocking H1-receptor sites to antagonize histamine effects including vasodilation, edema formation, and itching. The drug exhibits anticholinergic and sedative properties due to CNS penetration.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on margin defense and transition planning rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines competitively antagonize various physiological effects of histamine including increased capillary permeability and dilatation, the formation of edema, the "flare"…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Started Mar 2025
344 enrolled
Central Auditory Processing DisorderHearing Impaired (Partially)Hearing+23 more
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
Started Aug 2023
74 enrolled
Multiple Sclerosis (MS)Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Primary Progressive+4 more
Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Started Sep 2012
310 enrolled
Eczema
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.