The hepcidin antagonist pipeline has more than 10 drugs. In pipeline analysis, drugs are analyzed on the basis of route of administration and molecule type. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Pre-clinical stage.
Phase III clinical trial known for the comparison of new treatments with the standard treatment in which the safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. In Hepcidin antagonist, there are 3 drugs in phase III clinical trial. For instance, Luspatercept, a phase III drug candidate of Celgene Corporation is being developed in collaboration with Acceleron Pharma, Inc., for the treatment of anemia with myelodysplastic syndromes and anemia associated with beta thalassaemia.
NOX-H94 is a phase II drug candidate of NOXXON Pharma N.V. The drug candidate is an anti-hepcidin single-stranded structured L-RNA oligonucleotide conjugated to 40kDa polyethylene glycol. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. It takes around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.
PRS 080, a phase I/II drug candidate is under development by Pieris Pharmaceuticals, Inc. for the treatment of anemia. The drug candidate is an hepcidin antagonist, which can restore iron utilization and erythropoiesis. The company mentioned that the compound has successfully shown a favorable safety profile in healthy volunteers and is expected to complete a multi-dose trial by mid of 2017. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.
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Pipeline analysis provides description about the key companies developing hepcidin antagonist drugs. Some of the key players actively involved in the research and development are Celgene Corporation, Akebia Therapeutics, Inc., FibroGen, Inc., Noxxon Pharma AG and Tolero Pharmaceuticals, Inc.