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Jatenzo 6 articles

FDA panel shoots down oral testosterone therapy

A Food and Drug Administration (FDA) advisory panel voted not to approve Lipocine Inc.’s oral testosterone replacement treatment called Tlando, citing safety concerns involving blood pressure and heart rate, hematocrit, and serum lipids. Tlando, previously known in studies as LPCN 1021, are capsules that contain 112.5 mg testosterone undecanoate, an esterified testosterone derivative, combined with a propriety lipid formulation. Once taken orally, the testosterone is systematically absorbed primarily through the lymphatic system. The FDA’s Bone, Reproductive, and Urological Drugs Advisory Committee (BRUDAC) voted six in favor and 13 against approval of the drug based on its benefit/risk profile. The FDA ... Read More

FDA considers first oral testosterone treatment

Two drug companies – both plagued by fits and starts– are racing to see which will be the first to gain Food and Drug Administration (FDA) approval for the first testosterone pill that can be taken by mouth. This week Lipocine announced it had resubmitted a New Drug Application (NDA) to the FDA for LPCN 1021, it’s oral testosterone replacement therapy designed to boost testosterone in men with low levels of the male hormone, a condition called hypogonadism. Lipocine had previously submitted an NDA to the FDA in June 2016 but was rejected. The agency cited problems with the dosing ... Read More

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 companies fight over patent infringement

A patent infringement lawsuit filed against drug maker Lipocine Inc. by Clarus Therapeutics was dismissed by the U.S. District Court in Delaware. Clarus was suing Lipocine over claims that Lipocine’s key drug candidate, LPCN 1021, infringed Clarus’ patent of Clarus’ similar drug JATENZO. LPCN 1021 and JATENZO are experimental oral testosterone replacement therapy currently in Phase III clinical trials. They are designed for boost levels of the male hormone in men with hypogonadism, a deficiency of testosterone due to disease or defect. Testosterone treatments are generally administered by injection, topical gel, or nasal spray. Both LPCN 1021 and JATENZO aim ... 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