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L-PZQ ODT/kg · 1 trial · 1 indication
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1a: 4 to 6 years L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1. |
| Cohort 1b: 4 to 6 years Biltricide® 40 mg/kg | ACTIVE_COMPARATOR | Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 2: 2 to 3 years L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 3: 3 to 24 months L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 4a: 3 months to 6 years L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 4b: 3 months to 6 years L-PZQ ODT 60 mg/kg | EXPERIMENTAL | Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1. |
| Name | Type | Description |
|---|---|---|
| L-PZQ ODT 50 mg/kg | DRUG | Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1. |
| Biltricide® | DRUG | Participants received single oral dose of Biltricide® 40 mg/kg on Day 1. |
| L-PZQ ODT 60 mg/kg | DRUG | Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1. |
Inclusion Criteria: * Age of the participant is 4 to 6 years of age (Cohorts 1 and 4), 2 to 3 years of age (Cohorts 2 and 4) 3 to less than 24 months of age (Cohorts 3 and 4) * Participants are; Schistosoma (S.) mansoni positive (Cohorts 1, 2, and 3); diagnosis defined as positive egg counts in sto...
L-PZQ ODT is an orally disintegrating tablet formulation of praziquantel being developed for the treatment of schistosomiasis, a parasitic disease. It has been studied in healthy children and in children infected with Schistosoma parasites. The drug is currently in clinical development and is not yet approved.
L-PZQ ODT is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the palatability and efficacy of this new formulation of praziquantel in pediatric populations.
L-PZQ ODT has completed a Phase 1 clinical trial and a Phase 3 clinical trial. The Phase 1 study evaluated palatability in healthy children, while the Phase 3 study assessed the drug in children infected with Schistosoma. Both trials are completed, and the drug remains investigational.
L-PZQ ODT has been studied in two completed clinical trials. NCT02315352 was a Phase 1 cross-over study evaluating palatability of the orally disintegrating tablet versus current praziquantel tablets in healthy African children aged 6-11 years. NCT03845140 was a Phase 3 study in children with schistosomiasis.
L-PZQ ODT is a new orally disintegrating tablet formulation of praziquantel, an established antiparasitic drug. The 'L-PZQ' designation refers to the levo-enantiomer of praziquantel, which is the active form. This formulation is designed to improve palatability and ease of administration for children.