ZONALON (doxepin hydrochloride)
ZONALON is indicated for the treatment of Pruritus; Atopic Dermatitis; Lichen Simplex Chronicus.
Details
- Status
- Prescription
- First Approved
- 1994-04-01
- Routes
- TOPICAL
- Dosage Forms
- CREAM
ZONALON Approval History
What ZONALON Treats
3 indicationsZONALON is approved for 3 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pruritus
- Atopic Dermatitis
- Lichen Simplex Chronicus
ZONALON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZONALON's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZONALON treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZONALON
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02062632 results posted | MC13C1 NCI-2014-00253, MC13C1 | Ph 2 | terminated | Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy |
| NCT01156142 results posted | NCCTG-N09C6 NCI-2011-02049, CDR0000675520 | Ph 3 | completed | Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZONALON FDA Label Details
Indications & Usage
FDA Label (PDF)ZONALON is indicated for the treatment of Pruritus; Atopic Dermatitis; Lichen Simplex Chronicus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.