Products & Pipeline

Nitec’s portfolio of products and product candidates in clinical and pre-clinical development includes the following:


(a) TruNoc has already successfully completed phase 2 proof of concept trials in acute pain.

Nitec has a pipeline of clinical product candidates addressing the needs of patients with inflammation and pain-related diseases. The Company’s lead product candidate, Lodotra^™, successfully completed a European Phase 3 trial in RA in 2006. A dossier was submitted to 15 European countries in 2006 using the decentralized procedure and after successful completion the marketing authorization in these countries is expected in the second half of 2008. Lodotra^™ represents a new class of therapeutic, circadian cytokine modulators (CCMs), based on a proprietary night-time release formulation of prednisone. In addition, Nitec is also conducting a second pivotal phase-3 trial in preparation for the filing of a NDA with the FDA seeking US approval of Lodotra^™ for the treatment of the signs and symptoms of RA including morning stiffness. Lodotra^™ is also being developed for the treatment of severe asthma and polymyalgia rheumatica (PMR).

Nitec’s second product candidate is TruNoc (tarenflurbil), which is being developed as a treatment of neuropathic pain, osteoarthritis and other chronic inflammation and pain-related diseases. Nitec is conducting pharmacokinetic studies in preparation for phase 2 trials in neuropathic pain and osteoarthritis.