[1] As of 2009[update], apricitabine has closed its phase III clinical trial,[2] and has been granted fast track status by the United States Food and Drug Administration.
[4] In March 2011 it was announced by the company to the Australian Stock Exchange that the FDA had agreed that a new, shorter, single Phase III trial design, including about 300 patients dosed for 2 weeks, was required before approval.
[7] As a monotherapy, 1200 mg apricitabine per day reduced the viral load by up to 1.65 logs (45 fold) in a small, 10-day randomized controlled trial.
The most common side effects associated with its use were headache (although there was no significant difference between participants who took apricitabine and those given a placebo), nasal congestion, and muscle pain.
In vitro, apricitabine is effective against NRTI-(lamivudine and zidovudine)-resistant virus strains, including M184V and multiple thymidine analogue mutations (TAMs).