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We believe Tuclar, if approved by the FDA, will offer men and prescribing physicians a safe, effective and convenient oral testosterone (T)-replacement treatment. Tuclar's unique formulation enables us to increase the amount of testosterone undecanoate (TU) per softgel capsule, enhance rapid solubilization and bioavailability of TU and reduce the impact of food effects. |
Based upon input from the Food and Drug Administration (FDA), we are conducting a single pivotal Phase III study to support the filing of a New Drug Application, or NDA. Our open-label pivotal Phase III is actively enrolling 300 men with low testosterone(T). |
We conducted an extensive Phase II clinical program for Tuclar. The full program included four separate studies and enrolled 77 men with low testosterone (T). In our 30-day and seven-day repeat-dose Phase II studies, we treated men twice daily with the same Tuclar dose that we intend to evaluate in our pivotal Phase III study |