Lipocine Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy
Key Highlights
- ➤Health Canada approves TLANDO for testosterone replacement therapy in adult males
- ➤Canadian launch and commercialization planned by end of 2026
- ➤Verity Pharma holds exclusive North American commercial rights to TLANDO
- ➤Canada writes more than 700,000 TRT prescriptions annually
Expert Statements
Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine
“Men with low testosterone in Canada have been served largely by injections and topical gels, and Health Canada's approval of TLANDO means they will have access to a convenient oral option without needing dose titration.”
Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine
“This approval represents an important step in expanding the geographic reach of TLANDO and further validates the value of Lipocine's partnered commercial strategy. We look forward to supporting Verity as it prepares for launch in Canada.”
Dr. Neil Flesher, Chief Medical Officer of Verity Pharma
“Health Canada's approval of TLANDO gives Canadian men with hypogonadism and their physicians a new oral treatment option with a simple, fixed dosing regimen that does not require dose titration.”
Dr. Neil Flesher, Chief Medical Officer of Verity Pharma
“Starting and managing testosterone therapy can be complicated for both patients and prescribers, and a fixed dose can make treatment easier to start. We value our partnership with Lipocine and look forward to making TLANDO available to patients across Canada.”
Lipocine Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy PR Newswire
SALT LAKE CITY, Oct. 7, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced that, through Lipocine's licensing partner Verity Pharmaceuticals Inc (Verity Pharma), Health Canada has approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for the conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). Verity Pharma holds exclusive commercial rights to TLANDO in North America and is planning for launch and commercialization in the Canadian market by the end of 2026.
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