RK-023 - Yet Another Glaucoma Drug in Phase II. Clinical Trials for Hair Loss

RK-023 is the development code given to the new drug that is being currently tested in Japan for treating hair loss and hypotrichosis of the eyelashes in two separate clinical trials, both in the Phase II. Very little information is available about this new molecule apart from its definition as being a novel physiologically active fatty acid derivative. However, judging by the fact that this drug is thought to stimulate the growth of the scalp hair and eyelashes and the fact that it is being developed by R-Tech Ueno, a pharmaceutical venture specializing in ophthalmology and dermatology, makes us believe that it is a molecule similar to bimatoprost. Bimatoprost is a glaucoma treatment marketed under the trade name Lumigan by the specialty pharmaceuticals company Allergan, focusing on developing ophthalmic and dermatology pharmaceutical products. Allergan recently secured a second FDA approval for bimatoprost (the new trade name is Latisse) to be used for the treatment of hypotrichosis of the eyelashes. Thus it is hard to ignore the similarities between R-Tech Ueno and Allergan and their current developments in the area of hair loss research. For more information on bimatoprost hair loss research follow this link.

During Phase I. clinical study the safety and tolerability of RK-023 were examined and no adverse drug reactions were observed in any of the two studies (hair loss and eyelashes) and no ophthalmological findings such as lowering of the intraocular pressure were registered. This indicates that the secondary effect of lowering the intraocular pressure was expected to happen and, therefore, we assume that this substance might already be approved for treating glaucoma (most likely as Rescula, active substance unoprostone) or it is its close derivative.

The most comprehensive set of information we have about RK-023 regarding its hair loss project is from 2011 when the Phase IIa clinical study was completed. This clinical study was a double-blind, randomized and placebo-controlled study involving 48 male test subjects under the age of 44 with mild to moderate androgenetic alopecia. Two milliliters of RK-023 were applied to the thinning spots on the scalp twice daily for 13 weeks. Scalp photos, phototrichogram and subject’s self-assessment were used to assess the efficacy of the treatment. The group of patients treated with RK-023 showed possibility of improvement in photo-assessment and in numbers of terminal hairs (defined as 0.2mm and more) compared with the placebo group. In the next phase it will be important to compare the efficacy of this molecule versus its main competitor, topical minoxidil solution 5%. It is yet too early to draw conclusions but, if once approved, this drug should be available at no prescription.