- Lipocine Inc. , a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, announced today that Antares Pharma, Inc. issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has approved TLANDO™ (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
- Lipocine licensed the exclusive U.S. commercialization rights for TLANDO™ to Antares Pharma.
- API – Testosterone
- Description– TLANDO® is an oral treatment for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone in adult males
- Dosage form: Capsules
Company: Antares Pharma, Inc.
- Warnings and Precautions: -Tlando is associated with the following warnings and precautions: polycythemia, worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer, venous thromboembolism, potential for adverse effects on spermatogenesis, edema, sleep apnea, changes to serum lipid profile, and changes to serum prolactin levels.
- Side Effects -Common adverse reactions include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.
“The approval of TLANDO is a significant milestone achievement for Lipocine,” commented Dr. Patel. “I would like to thank the participants in our clinical trials, the investigators and their staff, key opinion leaders and consultants, and our employees who made this approval possible. We are excited that patients are one step closer to having the ability to access a much needed and convenient testosterone replacement option with TLANDO.”
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on neuroendocrine and metabolic disorders using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes: LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and oral neuroactive steroids including LPCN 1154 and LPCN 2101. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating potential utility in the treatment of non-cirrhotic NASH. LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once or twice daily, LPCN 1111 met primary and secondary endpoints. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. Neuroactive steroids are currently being evaluated including LPCN 1154 for the potential treatment of postpartum depression and LPCN 2101 for the potential treatment of epilepsy.