Istradefylline

Unassigned

New Medicines

Nourianz · Parkinson's disease

Information

Nourianz
New molecular entity
Kyowa Kirin
Kyowa Kirin

Development and Regulatory status

None
Phase III Clinical Trials
Launched
Oct 19 · Launched in US [11].
Aug 19 · Approved in US as add-on therapy to levodopa/carbidopa to treat ‘off episodes’ in adults with PD. Approval is based on four 12-week placebo-controlled RCTs (n=1,143) that all showed patients treated with istradefylline experienced a statistically significant decrease from baseline in daily "off" time compared to patients receiving a placebo [8].
Feb 08 · US non approvable letter (5)
May 07 · Filed in US (4).
Sep 06 · PIII trials completed in US and EU. Company plan to file in US late 06 (1). US filing postponed to Spring 07 due to request for non-clinical data (3).

Category

Adenosine A2A antagonist
Parkinsons disease typically develops between the ages of 55 and 65 years and occurs in 1-2% of people over the age of 60 years, rising to 3.5% at age 85-89 years. About 0.3% of the general population is affected, and the prevalence is higher among men than women, with a ratio of 1.5 to 1 [10].
Parkinson's disease
Oral

Trial or other data

Oct 16 · Kyowa Kirin have completed a PIII, 12-week study (n=613) evaluating efficacy of istradefylline 20 and 40 mg/day (NCT01968031) [9].
Jun 09 · III double-blind 12 week study (NCT00955526) began comparing istradefylline vs placebo in 360 patients. The primary endpoint is the reduction in the mean total hours of awake time per day spent in the OFF state. Estimated completion date: May 2011. A non-randomised, open label, uncontrolled safety PIII study (NCT00957203)
Sep 06 · First in class (2).