Biopharmaceutical company Lipocine has announced positive Phase I study results for novel once-a-day oral testosterone, LPCN 1111.
The novel prodrug of testosterone, LPCN 1111, leverages the company's Lip'ral technology to enhance solubility and improve absorption during testosterone replacement therapy.
Lipocine chief technology officer Dr Srinivasan Venkateshwaran said; "We are very pleased to report that data from the Phase I trial indicate that LPCN 1111 appears to be the first once-a-day, orally-active testosterone replacement therapy ever advanced into the clinic."
According to the study data, LPCN 1111 demonstrated a good safety profile and pharmacokinetic prolife, supporting once-a-day dosing of the next-generation oral testosterone replacement product.
The LPCN 1111 development programme adds to Lipocine's line of potential products, which include a twice-daily oral testosterone replacement, LPCN 1021, that is currently entering Phase III clinical trials.
Lipocine president and CEO Dr Mahesh Patel said new oral testosterone dosage forms will make a major contribution to the expanding market for testosterone replacement therapy.
"We believe a once-a-day product will be strongly differentiated and provide a significant advancement in this market. Based on these data, LPCN 1111 is poised to be the first such product in this class," Patel said.