Ngave, Françoise N.
Wonyarossi, Deogratias U.
Abhafule, Germain M.
Mande, Joël L.
Nyathirombo, Amos
Uvon, Claude B.
Raciu, Anuarite A.
Mandro, Michel
Adroba, Pascal T.
Ukety, Tony O.
Mananu, Innocent A.
Abeditho, Gisèle L.
Upenjirwoth, Jules U.
Aliang’o, Carine M.
de Dieu N. Unega, Jean
Nigo, Maurice M.
Bakajika, Didier
Uvoyo, Jean-Paul U.
Mambandu, Germain L.
Halleux, Christine M.
Vaillant, Michel
Schritz, Anna
Mosqueira, Beatriz
Mumbere, Mupenzi
Kinrade, Sally
Kuesel, Annette C. https://orcid.org/0000-0002-1696-1784
Funding for this research was provided by:
Special Programme for Research and Training in Tropical Diseases (A80196)
Medicines Development for Global Health, Australia
European and Developing Countries Clinical Trials Partnership (RIA2017NCT-184)
Fonds National de la Recherche Luxembourg ((FNR n°INTER/ EDCTP/ 17/12331087/ MoxiMultiDoseMod/ Michel Vaillant)
Article History
Received: 17 July 2025
Accepted: 3 December 2025
First Online: 16 March 2026
Declarations
:
: MDGH-MOX-3001 and MDGH-MOX-3002 protocols, information documents for potential participants, consent and assent forms, and study conduct were approved by the DRC National Ethics Committee (Comité National d’Ethique de la Santé) and the National Regulatory Agency (Direction de la Pharmacie et du Médicament/Autorité Congolaise de Règlementation Pharmaceutique, Ministère de la Santé Publique, Hygiène et Prévention (MoH)). Approvals for the P3 study were obtained from the Ethics Committee of the Ecole de la Santé Publique Université de Kinshasa and the MoH [ , , ]. All documents were also approved by the WHO Ethics Review Committee. Participants documented their consent or assent with parental consent to study participation through signature or thumbprint in the presence of a literate witness in or near their villages.
: BM was and MuMu and SK are staff of MDGH, Australia. In 2014, WHO licensed all data on moxidectin at its disposal to MDGH to prepare the New Drug Application for moxidectin to the US-FDA and make moxidectin available at an affordable cost. MDGH remains the regulatory sponsor of moxidectin. MDGH co-funded studies MDGH-MOX-3001 and MDGH-MOX-3002. ACK and CMH work for WHO, which funded the work of all co-authors on the P3 study through its department UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR). ACK retired from the WHO in March 2023 and is continuing to work for TDR as a consultant, including on studies MDGH-MOX-3001 and MDGH-MOX-3002.