Phase 1 clinical trials

Dicot's Phase 1 study of the potency drug candidate LIB-01 was a placebo-controlled and double-blind with the primary objective to investigate the safety profile in humans. It was conducted during August 2023 – April 2024 and consisted of two parts: single doses (SAD) and multiple doses (MAD). Dicot's now completed phase 1 clinical study demonstrates that the company's drug candidate LIB-01 has a very good safety profile, which was the primary objective of the study. In addition to this, the company can deduce an efficacy signal from the study where participants reported an improved erectile function, in some cases beyond 28 days post first dose.

The results also showed that the drug is well absorbed in the body.

”I am very impressed with Dicot’s Phase 1 study results. The safety data of LIB-01 look very good, which is crucial for a drug for erectile dysfunction (ED). And the fact that the effect in some cases lasted at least four weeks after a 3-day treatment is unique and has never been reported for an ED drug”, comments Professor François Giuliano, urologist and specialist in male sexual dysfunction, past-president of the European Society of Sexual Medicine.

“It has been 26 years since a new class of oral ED therapy was approved. LIB-01 appears to have the potential to positioning as a new first-line oral treatment. These results point to excellent safety and early indications of prolonged effect on restoring erectile function”, comments Harin Padma-Nathan, MD, past-Professor of Urology, University of Southern California, Principal Investigator for Viagra and Cialis.