This section highlights FDA-related milestones and regulatory updates for drugs developed by Xeris Biopharma (XERS).
Over the past two years, Xeris Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RECORLEV and Gvoke. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RECORLEV (levoketoconazole) FDA Regulatory Events
RECORLEV (levoketoconazole) is a drug developed by Xeris 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.
- Drug:
- RECORLEV (levoketoconazole)
- Announced Date:
- August 25, 2025
- Indication:
- endogenous Cushing's syndrome
Announcement
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."
AI Summary
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.
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Gvoke VialDx FDA Regulatory Events
Gvoke VialDx is a drug developed by Xeris Biopharma for the following indication: for Use as a Diagnostic Aid.
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.
- Drug:
- Gvoke VialDx
- Announced Date:
- March 17, 2025
- Indication:
- for Use as a Diagnostic Aid
Announcement
Xeris Biopharma Holdings, Inc. announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
AI Summary
Xeris Biopharma Holdings, Inc. announced that the FDA has approved its supplemental new drug application for Gvoke VialDx™. This approval allows the product to be used as a diagnostic aid during radiologic examinations, where it temporarily inhibits movement of the gastrointestinal tract in adult patients. The ability to reduce GI motility can help improve the quality and speed of imaging procedures.
The company is working with American Regent to bring Gvoke VialDx to the U.S. market, with expected availability in the third quarter of 2025. The product is designed to be a concentrated, ready-to-dilute liquid glucagon available in 1 mg per 0.2 mL single-dose vials. With this development, Xeris aims to offer enhanced procedural support in gastroenterology while reinforcing its commitment to innovative healthcare solutions.
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