NDATOPICALCREAM
Approved
Apr 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
ZONALON (doxepin hydrochloride) by Viatris is clinical pharmacology the mechanism of action of doxepin is not definitely known. First approved in 1994.
Drug data last refreshed 12h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZONALON (doxepin hydrochloride) is a topical cream formulation of a tricyclic compound approved in 1994 for dermatologic pruritus and itch-related conditions. The mechanism involves modulation of norepinephrine reuptake at synapses, combined with antihistamine and antiserotonin effects on smooth muscle. It is applied directly to affected skin areas to provide localized anti-itch relief.
$0.019BPart D
LOE ApproachingMinimal commercial activity with only $19K in Part D spending and 25 claims in 2023; team size is likely small and focused on maintenance rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanism of action of doxepin is not definitely known. It is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current hypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Started Dec 2010
155 enrolled
Head and Neck CancerMucositisOral Complications of Radiation Therapy+1 more
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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.