The IV iron therapy ferric bepectate is invented by the German company Serumwerk Bernburg, who will also be the producer of the API.
Our 5 guiding principles
The story so far
Initial plan launched to enter market using an application based on bibliographic data, plus a preclinical package and a phase-III clinical study in a hemodialysis population.
Foundation of iron4u with the specific purpose to develop and market ferric bepectate for iron deficiency.
Ferric bepectate was patented and a decision was made to go for a hybrid application, demanding more preclinical studies as well as a phase-1 clinical study.
Authorities concluded that they assumed the active ingredient to be the entire iron sugar complex, requiring more studies.
Knowledge obtained from initial studies shows that ferric bepectate’s properties differentiate significantly from existing human injectable iron products.
Based on the emerging strong product profile, decision was taken to go for full/mixed application in order to document the differences between ferric bepectate and other injectable iron products.
Preclinical phase completed
Clinical Phase I completed
Clinical Phase II completed
Initial discussions with licensing partners.
Initiation of International Phase III program