Phase 1 Clinical Study

The Phase 1 study of the LIB-01 candidate was conducted between August 2023 and April 2024 and consisted of two parts: single-dose administration (SAD) and multiple-dose administration (MAD).

The study was placebo-controlled and double-blind, with the primary objective of assessing the safety profile in humans.

Results showed that LIB-01 has a very strong safety profile, which was the study’s primary focus.Additionally, a clear efficacy signal was observed, with participants reporting improved erectile function lasting at least 28 days after the first dose. The results also confirmed efficient absorption of the drug 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", says 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.