Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
Levocetirizine is an investigational small molecule being developed for respiratory conditions including rhinitis, allergic rhinitis (perennial and seasonal), and dermatitis. It is currently in Phase 3 clinical development. Levocetirizine is being studied for use in these indications, though it is not yet approved.
Levocetirizine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of Levocetirizine for respiratory and dermatological indications.
Levocetirizine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is a safety study of Levocetirizine oral solution in Japanese pediatric patients with rhinitis.
Levocetirizine has been studied in three completed clinical trials. The Phase 3 trial (NCT01563081) evaluated the safety of Levocetirizine oral solution in 60 Japanese pediatric patients with rhinitis. Two Phase 1 trials (NCT01622283 and NCT02447393) assessed pharmacokinetics in healthy volunteers with allergic rhinitis and dermatitis.
Levocetirizine is a specific drug entity and is not identified as being the same as other antihistamines in the available information. It is being developed as a distinct small molecule for respiratory and dermatological conditions, with its own clinical trial program.