Strongbridge Biopharma (SBBP) FDA Approvals

Strongbridge Biopharma's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Strongbridge Biopharma (SBBP). Over the past two years, Strongbridge Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as RECORLEV. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

RECORLEV (levoketoconazole) FDA Regulatory Events

RECORLEV (levoketoconazole) is a drug developed by Strongbridge Biopharma for the following indication: endogenous Cushing's syndrome. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - August 25,2025

• Drug: RECORLEV (levoketoconazole)
• Announced Date: August 25, 2025
• Indication: endogenous Cushing's syndrome
• Other Companies Involved: NASDAQ:XERS

Xeris Biopharma Holdings, Inc announced the U.S Patent and Trademark Office has issued patent number 12,377,096 to the Company for Recorlev® (levoketoconazole) and that this patent is now listed in the publication, "Approved Drug Products with Therapeutics Equivalence Evaluations," commonly known as the "Orange Book."

Xeris Biopharma announced the U.S. Patent and Trademark Office has granted patent number 12,377,096 for Recorlev® (levoketoconazole), and this patent is now listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Titled “Methods of Treating Disease with Levoketoconazole,” it covers therapeutic uses that minimize drug-drug interactions between levoketoconazole and MATE1 substrate drugs. The patent’s protection extends through March 2040.

Listing in the Orange Book gives Xeris an official record of its intellectual property covering a drug the FDA deems safe and effective. This listing helps Xeris monitor and guard against potential generic competition. With four Orange Book-listed patents now protecting Recorlev, Xeris’s CEO John Shannon said the company is committed to strengthening the product’s long-term value and supporting patients with rare endocrine diseases. The new patent brings Recorlev’s total Orange Book patents to four, extending exclusive rights and underlining Xeris’s confidence in the therapy’s growth potential.

Provided Update - June 3,2024

• Drug: RECORLEV (levoketoconazole)
• Announced Date: June 3, 2024
• Indication: endogenous Cushing's syndrome
• Other Companies Involved: NASDAQ:XERS

Xeris Biopharma Holdings, Inc. announced it presented a post-hoc analysis from its previously published SONICS study on the effects of levoketoconazole (Recorlev®) in adults with Cushing's syndrome at ENDO 2024 in Boston, June 1-4, 2024.

Xeris Biopharma Holdings, Inc. presented new findings at ENDO 2024 in Boston from a post-hoc analysis of its previously published SONICS study. The analysis focused on levoketoconazole (Recorlev®) for treating adults with Cushing’s syndrome. It revealed that patients with a lower baseline level of mean urinary free cortisol (mUFC) achieved higher cortisol normalization rates. These patients also generally required lower maintenance doses and experienced fewer liver-related adverse events and test abnormalities. In contrast, individuals with higher baseline mUFC levels needed higher doses and had a greater occurrence of liver issues. The results highlight the value of tailoring treatment based on individual baseline disease severity to improve both the effectiveness and safety of therapy with Recorlev.

Strongbridge Biopharma FDA Events - Frequently Asked Questions

Has Strongbridge Biopharma received FDA approval?

As of now, Strongbridge Biopharma (SBBP) has not received any FDA approvals for its therapy in the last two years.

What drugs has Strongbridge Biopharma submitted to the FDA?

In the past two years, Strongbridge Biopharma (SBBP) has reported FDA regulatory activity for RECORLEV (levoketoconazole).

What is the most recent FDA event for Strongbridge Biopharma?

The most recent FDA-related event for Strongbridge Biopharma occurred on August 25, 2025, involving RECORLEV (levoketoconazole). The update was categorized as "Provided Update," with the company reporting: "Xeris Biopharma Holdings, Inc announced the U.S Patent and Trademark Office has issued patent number 12,377,096 to the Company for Recorlev® (levoketoconazole) and that this patent is now listed in the publication, "Approved Drug Products with Therapeutics Equivalence Evaluations," commonly known as the "Orange Book.""

What conditions do Strongbridge Biopharma's current drugs treat?

Currently, Strongbridge Biopharma has one therapy (RECORLEV (levoketoconazole)) targeting the following condition: endogenous Cushing's syndrome.