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Therapeutic Areas: Anxiety, Social Phobia, Sexual Dysfunction
Phase of Development: Phase II

Development Status:
FKW00GA is unique in that it will be the first 5HT1A Agonist and 5HT2 Antagonist on the market for the treatment of anxiety. FKW00GA’s mechanism of action indicates that this product would be beneficial for both anxiety and sexual dysfunction. Initially, this product will be developed for social phobia. After the product is on the market, FKP plans to register it for other indications such as generalized anxiety disorder, mixed anxiety depression and sexual dysfunction.

FKW00GA is a nonbenzodiazepine anxiolytic that should not have benzodiazepine-like or anticholinergic side effects. Preclinical studies have shown it to have a very high affinity for the serotonin 1A (5HT1A) receptor. In addition, FKW00GA has a high affinity for the serotonin 2 (5HT2) receptor. The 5HT1A partial agonist and 5HT2 antagonist activities of FKW00GA suggest the agent will have beneficial properties for the treatment of anxiety and sexual dysfunction.

Clinical Trials
In Phase I trials, FKW00GA is safe and tolerated up to single doses of 180 mg and multiple doses of 60 mg T.I.D. for 7 days. Adverse effects were minimal consisting mostly of light headedness and nausea. Several Phase II studies were conducted in generalized anxiety disorder. Signals indicating efficacy were found. Phase III protocol for the existing formulation has been submitted to FDA. An extended release formulation will achieve better patient compliance and a lower side effect profile. Presently, several different extended release prototypes are in development. A new formulation will help to maximize the market potential of this drug.

Developmental and licensing opportunities are available.