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.
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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.
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By GlobalData"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.
