DRGT Announces the U.S. FDA IND Application Approval and First Dosing of a Clinical Trial to Evaluate the Bioavailability and Food Effect of Immediate-Release Formulation of Tadalafil (DRGT-99)
A previous phase 1, single-center, dose-ranging trial demonstrated that oral administration of DRGT-99 tablets was associated with a faster time to peak plasma concentration compared to Cialis®. Dr. John Friend, Chief Medical Officer at DRGT, recently noted, “Our initial observations with DRGT-99 are in line with our goal of developing a best-in-class therapy for erectile dysfunction that combines faster onset with a long half-life, while minimizing side effects”.
Erectile dysfunction (ED) is the inability for men to obtain or keep an erection that is firm enough for intercourse. Erectile dysfunction is a common disorder in men over 40 years of age, and can be attributed to conditions that reduce blood flow (diabetes, cardiovascular disease, high cholesterol, nerve damage to name a few). It is estimated that the global ED market will grow substantially due to increasing rates of hypertension, diabetes, and neurologic conditions that affect erectile function, as well as increased patient awareness of treatment options.
Tadalafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), is currently indicated for the treatment of ED, benign prostatic hyperplasia (BPH), concomitant ED and BPH, and pulmonary arterial hypertension. Known for a longer duration of action compared to other options for ED, initial absorption of tadalafil can be variable, with only a minority of men reporting successful intercourse 30 minutes after taking the highest-approved dose of tadalafil. Improved and consistent absorption of tadalafil is an important unmet need for ED therapy. The DRGT-99 formulation has improved the solubility and dissolution of tadalafil in vitro.
This study will enroll healthy male subjects who will receive single doses of DRGT-99 (5 or 15 mg tadalafil) or Cialis® (20 mg tadalafil) with or without food. Results from this study are expected early next year and will be discussed with the FDA.
DRGT is a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs that deliver measurable and meaningful improvements in clinical utility. DRGT utilizes its proprietary Super-API drug development platform to rapidly select, screen and develop drugs with enhanced pharmacokinetics, which could lead to improved efficacy and safety. The Company’s Super-API portfolio contains 30 compounds across a variety of indications and are protected by global composition of matter Intellectual Property. The company was founded by Dr. Ferenc Darvas, who is also the Chairman of the oldest Hungarian upstream-technology network.
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Cialis® is a registered trademark of Eli Lilly and Company