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Lipocine Inc. 5 articles

Clarus seeks FDA approval for oral testosterone

Biotech firm Clarus Therapeutics resubmitted its New Drug Application (NDA) for Jatenzo, an oral version of testosterone, hoping the drug will become the first oral testosterone product on the market. Clarus has been in a head-to-head race with Lipocine Inc.’s LPCN 1021 to gain Food and Drug Administration (FDA) approval for an oral testosterone treatment. Lipocine’s bid for FDA clearance was shot down in early 2016 after regulators questioned the dosing algorithm. The company responded by submitting a new dosing validation study protocol, which the FDA reviewed and approved. That study is currently underway. The NDA for Jatenzo was initially submitted ... Read More

Lipocine still working for FDA approval for first testosterone pill

Lipocine Inc.’s journey to Food and Drug Administration (FDA) approval for the first testosterone pill known as LPCN-1021 has been rife with obstacles. In June, regulators rejected the company’s bid for marketing approval for the synthetic hormone pill, saying there were deficiencies related to the dosing algorithm that would first need to be ironed out. The company responded by submitting a new dosing validation study protocol, which the FDA agreed to review under a special protocol assessment (SPA). If the SPA is approved, Lipocine would need to carry out the validation study in order to secure another review. Just as ... Read More

Testosterone therapy makers eager to market first oral testosterone treatment

Pharmaceutical companies are working vigorously to test testosterone formulations to become the first oral testosterone treatment on the market already well populated with testosterone patches, creams, gels, implants and injections. But in order to win Food and Drug Administration (FDA) approval, they will have to prove they are safe and effective, and will be used only for the condition for which they are intended to treat. This month, Clarus Therapeutics, Inc., announced that its proprietary oral testosterone replacement product Jatenzo, formerly named Rextoro, was currently being tested in patients under a newly launched Phase 3 clinical trial. The announcement comes two years ... Read More

FDA to consider approval of first oral testosterone treatment

Lipocine Inc., a specialty pharmaceutical company, has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in hopes of gaining approval of the first oral testosterone replacement therapy for adult males with hypogonadism, a condition in which men do not produce enough testosterone due to disease or defect. The FDA says it expects to have its review of the drug, known as LPCN 1021, completed by June 28, 2016. Testosterone treatments are currently available by prescription in topical gels, patches, nasal sprays, and injections. Oral versions of the hormone have been difficult to formulate because the ... Read More

First oral testosterone treatment on track to seek FDA approval

Pharmaceutical company Lipocine Inc. is poised to gain Food and Drug Administration (FDA) approval for LPCI 1021, the first swallowable oral testosterone treatment that investors say could make the company’s shares rise more than 80 percent of all goes smoothly. Testosterone treatments generally come in topical gels or patches that deliver testosterone through the skin, or injections that are administered with a shot. The gels are the most popular version though they carry a black box warning because they can be unintentionally transferred to women, children and pets. Thus, an oral version of testosterone would be more convenient than other ... Read More