Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication XYZAL is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. FDA label
Levocetirizine · 3 trials · 3 indications
A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of \>=5%, please see the SAE/non-serious AE module of this record.
AUC(0-48): Area under plasma concentration time curve from pre-dose to 48h.
Cmax: Maximum observed concentration.
Area Under the time-concentlation curve
| Arm | Type | Description |
|---|---|---|
| Levocetirizine | EXPERIMENTAL | Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution |
| Levocetirizine oral solution 5 mg | EXPERIMENTAL | Levocetirizine oral solution 5 mg |
| Cetirizine dry syrup 10 mg | ACTIVE_COMPARATOR | Cetirizine dry syrup 10 mg |
| cetirizine | OTHER | Study Drug |
| placebo | OTHER | Study Drug |
| Name | Type | Description |
|---|---|---|
| Levocetirizine | DRUG | Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered once daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning to infants aged between 6 months and 1 year old |
| Cetirizine | DRUG | Cetirizine |
| placebo | DRUG | placebo |
Inclusion Criteria: * Outpatients * Either boys or girls are acceptable. * Pediatric patients ranging from 6 months to 2 years in age at the time of initiation of the treatment in clinical trial * Pediatric patients who have at least one of the symptoms associated with allergic rhinitis including r...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Levocetirizine is a small molecule drug developed by GSK plc (ticker: GSK). It is being studied in clinical trials for dermatitis and for perennial and seasonal allergic rhinitis. It is an investigational therapy in clinical development and is not described as approved in the available trial information.
Levocetirizine is being studied for dermatitis and for rhinitis, including perennial and seasonal allergic rhinitis. Clinical trials have enrolled patients with these conditions, and one Phase 3 safety study was conducted in Japanese pediatric patients with rhinitis. These uses remain investigational and are being evaluated in clinical development.
Levocetirizine targets HRH1, the histamine H1 receptor, and acts as an antagonist at this receptor. By blocking HRH1, it interferes with histamine signaling, which is relevant to allergic and inflammatory conditions such as allergic rhinitis and dermatitis that the drug is being studied in.
Levocetirizine is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with the clinical development program for this small molecule across dermatitis and allergic rhinitis indications.
Levocetirizine is in Phase 1 development according to its overall program status, though individual completed trials have included a Phase 3 safety study. It is an investigational drug still in clinical development and is not described as FDA approved in the available information.
Levocetirizine has been studied in completed trials including NCT02447393, a Phase 1 study in dermatitis in Japan, NCT01622283, a Phase 1 pharmacokinetic study of the oral solution in perennial and seasonal allergic rhinitis, and NCT01563081, a Phase 3 safety study of the oral solution in Japanese pediatrics with rhinitis.