Kythera Biopharmaceuticals has submitted an Investigational New Drug Application to US regulators requesting permission for human trials of its experimental male pattern hair loss treatment KYTH-105.

The US biotech wants to carry out a human proof-of-concept study to assess efficacy and safety of KYTH-105 (setipiprant) in male subjects with AGA, an inherited genetic disorder causing a recession of the hairline, hair thinning and progression to partial or complete baldness.

Setipiprant is a selective oral antagonist of the prostaglandin D2 (PGD2) receptor - a possible key variable in hair loss. 

The drug, to which Kythera bought a license from Actelion earlier this year, is a well-characterised molecule “supported by a large safety database”, having prevsiouly been tested in more than 1,000 patients in asthma and allergic rhinitis trials.

With more than 35 million American men experiencing hair loss, demand for a safe and effective treatment remains high, Kythera notes, adding that its drug “represents a unique scientific approach to the treatment of hair loss that has the potential to help millions of men achieve a positive self-image”.