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
Gvoke, RECORLEV, and XeriSol. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Gvoke VialDx - FDA Regulatory Timeline and 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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RECORLEV (levoketoconazole) - FDA Regulatory Timeline and 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:
- June 3, 2024
- Indication:
- endogenous Cushing's syndrome
Announcement
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.
AI Summary
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.
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XeriSol Levothyroxine (XP-8121) - FDA Regulatory Timeline and Events
XeriSol Levothyroxine (XP-8121) is a drug developed by Xeris Biopharma for the following indication: Hypothyroidism.
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:
- XeriSol Levothyroxine (XP-8121)
- Announced Date:
- May 30, 2024
- Indication:
- Hypothyroidism
Announcement
Xeris Biopharma Holdings, Inc announced topline results from its recently completed Phase 2 multi-center, open label, study of XP-8121 for the treatment of adults with hypothyroidism. XP-8121 employs the Company's XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.
AI Summary
Xeris Biopharma recently announced promising topline results from its Phase 2, multi-center, open-label study evaluating XP-8121 in adults with hypothyroidism. XP-8121 uses the Company’s innovative XeriSol™ formulation technology to provide a once-weekly subcutaneous injection of levothyroxine. The study showed that patients achieved normalized TSH and T4 levels while using 45% less drug compared to their daily oral levothyroxine doses. Researchers established that the effective weekly dose was about four times the daily oral dose, confirming earlier Phase 1 observations. Additionally, most participants (72%) preferred the subcutaneous route over the traditional oral method, citing benefits such as convenience and ease of administration. These findings suggest that XP-8121 could potentially help overcome the challenges associated with maintaining stable thyroid hormone levels using daily oral therapies.
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