FDA Grants Orphan Drug Designation for Novel Malaria Drug

The FDA granted orphan drug designation to an investigational treatment for malaria.

The Food and Drug Administration (FDA) has granted orphan drug designation to Artemisone (Artemis) an investigational treatment for P falciparum malaria.

Artemisone is a synthetic artemisinin derivative with potent anti-viral and anti-parasitic properties. “We believe [Artemisone] may offer more attractive safety and efficacy profile compared to currently-available artemisinins,” said Brian M. Culley, CEO of Artemis.

According to a media release earlier this year by the World Health Organization, artemisinin resistance has grown in certain parts of the world and the spread of resistance could pose a major health security risk. 

The Company stated that they will now move toward additional clinical trials of the treatment. As well as malaria, they are also evaluating Artemisone for the treatment of human cytomegalovirus (CMV) infections, including stem cell transplant CMV and congenital CMV.

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Artemis Therapeutics receives orphan drug designation from US food and drug administration for Artemisone for the treatment of malaria [press release]. New York, New York: Artemis Therapeutics. Published online November 6, 2017. Accessed November 10, 2017.

This article originally appeared on MPR