The Androgen Restored Contraception (ARC) project is in phase III development and clinical studies are in preparation for Europe. Based on scientific advices obtained with the registration authorities (EMA and FDA), only a limited phase III program will need to be performed.
In January 2019 Pantarhei Bioscience (PRB) out-licensed the ARC pill for final product development, regulatory approval and commercialisation to the Hungarian pharma company Gedeon Richter for Europe, Russia, Latin America and Australia. Pantarhei is still looking for pharmaceutical partners to finalise the clinical development and bring the ARC Pill to the market in the US and Asia. Most recent patent is filed in July 2011, so the project is patent protected until 2031. Fertile women have 5-10 times higher levels of testosterone (T), a male hormone, than estradiol (E2), a female hormone. When such women use a combined oral contraceptive pill (COC), both T and E2 are suppressed. The loss of E2 is compensated by the estrogen component of the pill (ethinyl estradiol (EE)). However testosterone is not substituted. The most important clinical consequences of the loss of testosterone are diminished sexual function and mood changes.
ARC is a novel concept of oral contraception developed and patent protected by PRB with the aim to preserve sexual function and prevent mood disturbances. This is achieved by adding dehydroepiandrosterone (DHEA) to the COC. DHEA is a natural human adrenal androgen, that is metabolised partially to testosterone after oral intake. By the addition of 50 mg DHEA normal levels of testosterone are maintained or restored during the use of a contraceptive pill. The longstanding safety track record of DHEA in the human at the low dose level used implies expected safety when DHEA is added to the pill.
A phase II development program has been performed by PRB demonstrating the efficacy and safety of the ARC pill concept. Favourable clinical effects on sexual function, especially sexual desire and arousability, and on menstrual cycle related mood symptoms were shown.