Where we stand

2019

  • -
    Access & Registration

    Submission of Registration dossier

    Provided positive outcome of the Phase III, tThe submission of the registration dossier is planned for the second half of 2018. As part of an ongoing process, details of the regulatory pathway are being discussed with the appropriate regulatory authorities

2018

  • -
    Development program

    Phase III clinical trial

    In 2017 the Consortium has planned a Phase III pediatric clinical trial in Africa. Details of the trial, such as design and countries, are currently being discussed.

2016

  • June
    Development program

    First patient dosed in Phase II clinical trial

    On 16 June 2016, the Consortium announced that he first patient in a Phase II pediatric clinical trial being conducted in the Ivory Coast has been dosed.

2015

  • December
    Development program

    Phase I bioavailability studies completed

    The phase I bioavailability studies in healthy adult volunteers were performed in South Africa with the aim to determine the pharmacokinetic properties of the Racemate (Rac)-PZQ and L-PZQ formulation candidates in comparison to the current 600 mg PZQ commercial racemate tablet formulation (Cesol). Both formulation candidates showed a good safety profile and acceptable palatability.

  • December
    Development program

    Swill-and-spit taste study completed

    A swill-and-spit taste study was performed in 2015 in Tanzanian school-age children. The study demonstrated that the tastes of the new L-PZQ ODT and the Rac-PZQ ODT tablets were improved compared to the taste of the Cesol 600 mg PZQ commercial racemate tablet formulation.  

  • May
    Consortium

    Consortium awarded US$4.9 million GHIT grant

    The Pediatric Praziquantel Consortium, a Consortium dedicated to the development of a new pediatric formulation against schistosomiasis received almost USD4.9 million from the Japanese Global Health Innovative Technology (GHIT) Fund. 

2014

  • November
    Development program

    Meta-analysis of praziquantel in children published in PLOS NTD

    A meta-analysis of the use of praziquantel in children has been conducted to guide the clinical development strategy, and has been published in PLOS Neglected Tropical Diseases in 2014.

  • August
    Access & Registration

    Expert Meeting 3: Regulatory Activities

    Regulators from many different African countries took part in a recent Pediatric Praziquantel Consortium meeting, held in Geneva in October. An intensive two-day agenda encompassed discussions of the entire regulatory approach for the Consortium’s new praziquantel pediatric formulation.

  • September
    Formulation

    Tech Transfer Rac-PZQ from Astellas to Farmanguinhos Completed

    Tech Transfer of the pediatric formulation processes from Astellas to Farmanguinhos for the racemate PZQ tablets to produce GMP batches for the clinical supplies have been completed.

  • March
    Consortium

    Consortium awarded US$1.86 million GHIT grant

    The Pediatric Praziquantel Consortium, launched in 2012 as an international non-profit public-private partnership, has announced that it has been awarded a prestigious research grant from the Japanese Global Health Innovative Technology (GHIT) Fund.

  • February
    Consortium

    Farmanguinhos and Simcyp join as full partners

2013

  • December
    Formulation

    Tech Transfer L-PZQ from Astellas to Merck Completed

    Tech Transfers of the pediatric formulation processes from Astellas to Merck for the L-PZQ tablets to produce GMP batches for the clinical supplies have been completed.

  • November
    Development program

    Pre-clinical development: no toxicity issues Rac-PZQ and L-PZQ

    A pre-clinical package comparing the racemate PZQ and the L-PZQ was initiated in October 2012 and was completed in November 2013. No toxicity issues have been reported.

  • August
    Consortium

    Bill & Melinda Gates Foundation grants $1.15 million

     The Bill & Melinda Gates Foundation grants $1.15 million to support some research & development activities before Phase I clinical trials. The current partners in this consortium, coordinated by TI Pharma, are Merck KGaA, Astellas Pharma Inc. and the Swiss Tropical and Public Health Institute ("Swiss TPH").

  • August
    Development program

    Expert Meeting 2: Clinical Design

    In August 2013, a second Expert Meeting was organized, evaluating design of the clinical studies needed to register the new PZQ  formulation with the help of international experts, including clinicians from endemic countries.

2012

  • August
    Formulation

    Expert Meeting 1: Target Product Profile

    Soon after its formation, the Consortium collaborated with a panel of experts in schistosomiasis and pediatric formulations, at a meeting in Geneva in August 2012. The goal was to develop a target product profile (TPP) delineating both required and desirable formulation features. Factors taken into account included therapeutic indications, pediatric age group, dosage form, frequency of administration, formulation storage conditions and more.

  • July
    Consortium

    Start Pediatric Praziquantel Consortium

    A newly established international public-private partnership (PPP) between TI Pharma (now Lygature), Merck KGaA (Darmstadt, Germany), Astellas Pharma Inc. and the Swiss Tropical and Public Health Institute ("Swiss TPH") has been launched to develop a new pediatric formulation of praziquantel to combat schistosomiasis - commonly known as bilharzia - in preschool children.