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Clarus Therapeutics 9 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

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

New testosterone replacement capsule fares well in clinical trials

Clinical trials for Clarus Therapeutic’s new testosterone replacement treatment Rextoro show the drug is comparable to other testosterone therapies and, if approved by the Food and Drug Administration (FDA), could provide patients with yet another treatment option to boost the amount of the male hormone in their systems. Rextoro is a softgel capsule that contains a testosterone prodrug, testosterone undecanoate, or TU. It is formulated to foster absorption via the intestinal lymphatic pathway. After oral TU is absorbed, natural enzymes in the body cause testosterone to be released from the prodrug. “This proprietary formulation enables us to increase the amount ... Read More

Drug company anticipates launch of new oral testosterone treatment

Clarus Therapeutics, an emerging men’s health specialty pharmaceutical company, filed with the Securities and Exchange Commission (SEC) this week to raise up to $86 million in an initial public offering. The biotech company is preparing for the commercial launch of REXTORO, an oral testosterone replacement therapy for which the company has submitted a New Drug Application with the Food and Drug Administration (FDA). If approved, REXTORO will be the first oral testosterone treatment available in the United States. The drug is intended to boost testosterone levels in men with low testosterone levels, also known as hypogonadism. The term “Low T” ... Read More