Testosterone replacement therapy (TRT)

Search documents
Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada
Prnewswire· 2025-06-09 12:00
Core Viewpoint - Lipocine Inc. announced that its licensing partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada, marking a significant step towards making this oral testosterone replacement therapy available in the Canadian market [1][2]. Company Overview - Lipocine is a biopharmaceutical company focused on developing effective oral delivery of therapeutics using its proprietary technology platform [5]. - The company has several drug candidates in development, including LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy, among others [6]. Product Information - TLANDO is the first and only oral testosterone replacement therapy approved by the FDA that does not require dose titration, targeting conditions associated with a deficiency of endogenous testosterone in adult males [4][6]. - The product was developed using Lipocine's proprietary Lip'ral drug delivery technology platform [4]. Market Opportunity - Canada has over 700,000 annual prescriptions for testosterone replacement therapy (TRT), with approximately 50% of patients covered by private insurance, indicating a substantial market opportunity for TLANDO [2][8]. - Limited promotional activities for existing TRTs in Canada may allow TLANDO to capture a significant market share [2].