Where we stand

2022

  • -
    Access & Registration

    Access in first endemic countries in Africa

    Local registrations and product availability in first endemic countries in Africa.
  • -
    Access & Registration

    European Medicines Agency Positive Opinion (Article 58)

    The Consortium, in case of a successful outcome of the clinical program, aims to submit the Marketing Authorization Application in 2021 to have the product approved in 2022. In parallel, the Marketing Authorization Application shall be submitted in Brazil (provided that no separate Phase III trial in Brazil is needed).

2021

  • -
    Access & Registration

    Submission of Registration dossier to EMEA

    The Consortium, in case of a successful outcome of the clinical program, aims to submit the Marketing Authorization Application in 2021 to have the product approved in 2022. In parallel, the Marketing Authorization Application shall be submitted in Brazil (provided that no separate Phase III trial in Brazil is needed).

2019

  • September
    Development program

    Sep 2019: First patient dosed in Phase III clinical trial

    On 18 Sept 2019, the Pediatric Praziquantel Consortium announced that the first patient in a Phase III pediatric clinical trial being conducted in Kenya and Ivory Coast has been dosed.
  • Spring
    Consortium

    Mar 2019 Consortium awarded US$4,1 million

    A supplementary US$ 4.1 million investment from the GHIT Fund has further reinforced the Pediatric Praziquantel Consortium’s efforts to develop, register and provide access to a novel orally dispersible praziquantel tablet formulation for children. It will help the Consortium in its efforts of bringing closer the treatment of preschool-age children suffering from schistosomiasis.

    Read more.
  • April
    Development program

    Taste study results published

    https://www.biorxiv.org/content/10.1101/605170v1

2018

2017

  • Winter
    Development program

    Phase II Part 1 completed

    A phase II dose-finding study is being performed in Côte d’Ivoire in S. mansoni-infected children of different ages (range 3 months to 6 years) from 2016-2018. The study part involving the age group 2-6 years was completed in 2017 and confirmed the formulation (L-PZQ) and the dose that will be pursued by the Consortium until registration.

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  • December
    Consortium

    EDCTP and GHIT Fund co-fund Phase III Study

    On 8 December, the European & Developing Countries Clinical Trials Partnership (EDCTP) and The Global Health Innovative Technology Fund (GHIT) announced that they will be co-funding the Phase III clinical study conducted by the Pediatric Praziquantel Consortium. 

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  • March
    Consortium

    Consortium awarded US$4.7 million GHIT grant

    On 30 March 2017, the GHIT Fund announced that it will continue to support the Pediatric Praziquantel Consortium. 

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  • March
    Consortium

    Consortium shares its experience with organizing expert meetings in PLOS NTD

    By sharing experiences from the Consortium, the PLOS NTD Symposium Article highlights the crucial role of expert meetings in PPPs targeting NTDs.

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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.

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2015

  • 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.  

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  • 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.

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  • 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. 

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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.

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  • 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.

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  • 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.

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  • 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.

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  • February
    Consortium

    Farmanguinhos and Simcyp join as full partners

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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.

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  • 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.

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  • 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").

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  • 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.

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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.

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  • 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.

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