- Parent company: EMD Serono, Inc.
- Given via oral intermittent administration in treatment cycles.
- Treatment cycles are four-to-five doses on consecutive days, ranging from once every 28 days to twice yearly, depending on the study regimen.
- Interferes with the behavior and proliferation of immune-system cells.
- Designated as a Fast Track product (for relapsing forms of MS) by the FDA for potentially quicker approval; Fast Track programs help to expedite the development of new drugs aimed at treating serious conditions.
- Enrollment complete for two-year, Phase III, multi-center CLARITY study in progress; will assess the safety and efficacy of oral cladribine (using two dose levels) versus a placebo in RRMS
ONWARD Phase IIb study combines oral cladribine with the new formulation of Rebif; study in progress.