Second Patent Issued to Strongbridge’s Recorlev for Treatment of Cushing’s Syndrome

Strongbridge Biopharma recently received a second patent from the U.S. Patent and Trademark Office covering the use of Recorlev (levoketoconazole) for the treatment of Cushing’s syndrome.

The patent (No. 9,918,984) is titled “Methods and Compositions for Treating Diabetes, Metabolic Syndrome and Other Conditions” and will be active until Jan. 10, 2026, plus eventual extensions. It covers methods of treating Cushing’s syndrome, as well as other conditions.

The first patent on Recorlev, issued in December 2015 (No. 9,198,906), covers methods of reducing C-reactive protein levels and inflammation through a once-daily dose of the therapy. It expires Dec. 29, 2030.

“This patent issuance represents an important milestone in our ongoing efforts to further develop intellectual property protection for Recorlev,” Matthew Pauls, president and CEO of Strongbridge, said in a press release. “The granting of this patent further strengthens our leadership position in rare endocrine disease and marks an important step in our continued efforts to optimize the value of Recorlev.”

Cushing’s syndrome refers to any collection of symptoms caused by an excess of the hormone cortisol, which regulates various processes within the body. Several factors may cause Cushing’s syndrome, including long-term, regular use of corticosteroids to treat a different condition, or a tumor on the pituitary gland, adrenal gland, or another part of the body.

Recorlev was developed by Strongbridge to treat the elevated levels of cortisol that are associated with Cushing’s syndrome. It is specifically designed for endogenous Cushing’s syndrome, which occurs when the body itself produces too much cortisol, as opposed to excess external cortisol from corticosteroids, for example. The therapy is a cortisol synthesis inhibitor, meaning it keeps the adrenal gland from producing too much cortisol.

Recorlev is currently being evaluated for its safety and effectiveness in an open-label SONICS Phase 3 clinical trial (NCT01838551) and in the placebo-controlled LOGICS Phase 3 trial (NCT03277690) in adults with Cushing’s.

Researchers leading the LOGICS study are still recruiting participants. They plan on enrolling up to 40 patients across 40 sites worldwide. Additional information on eligibility criteria and contact information is available on the study’s webpage or on its contact form.

In January, the company announced that the U.S. Patent and Trademark Office had completed a first review of its patent application. Recorlev had previously received orphan drug status from the U.S Food and Drug Administration (FDA) and European Medicines Agency (EMA) as a treatment for endogenous Cushing’s syndrome.