LEVOCETIRIZINE HYDROCHLORIDE (levocetirizine dihydrochloride)
LEVOCETIRIZINE HYDROCHLORIDE is indicated for the treatment of Hay Fever.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-04-01
- Routes
- ORAL
- Dosage Forms
- SOLUTION
LEVOCETIRIZINE HYDROCHLORIDE Approval History
What LEVOCETIRIZINE HYDROCHLORIDE Treats
1 indicationsLEVOCETIRIZINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hay Fever
LEVOCETIRIZINE HYDROCHLORIDE 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.
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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04699604 HAS3 | STUDY00001262 5R01HD100545-05 | Ph 3 | recruiting | A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3) |
| NCT06632405 | CAnTiH | Ph 2 | not yet recruiting | A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC |
| NCT00621959 results posted | A00430 | Ph 4 | completed | A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis |
| NCT01567501 | Ipca/ARL/059 | Ph 1 | completed | Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition |
| NCT00653224 results posted | A00431 | Ph 4 | completed | A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis |
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.
LEVOCETIRIZINE HYDROCHLORIDE FDA Label Details
Indications & Usage
LEVOCETIRIZINE HYDROCHLORIDE is indicated for the treatment of Hay Fever.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment