FDA Approves Xeris Biopharma's Gvoke VialDx as First Ready-to-Dilute Liquid Glucagon for Gastrointestinal Diagnostics
核心洞察
The FDA has approved Xeris Biopharma (搜索)'s Gvoke VialDx (搜索) as a diagnostic aid to temporarily inhibit gastrointestinal tract movement during radiologic examinations in adult patients.
Xeris has partnered with American Regent (搜索) for commercialization, with Xeris handling product supply and American Regent managing U.S. market distribution, targeting availability in Q3 2025.
As the first concentrated, ready-to-dilute liquid glucagon for diagnostic procedures, Gvoke VialDx (搜索) aims to modernize administration in the growing procedural gastroenterology market, which performs an estimated 20 million endoscopic procedures annually.
Xeris Biopharma (搜索) Holdings, Inc. (Nasdaq: XERS) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Gvoke VialDx (搜索), a gastrointestinal motility inhibitor for use during radiologic examinations in adult patients. The approval marks a significant advancement in diagnostic imaging procedures, offering a novel formulation of glucagon specifically designed for medical imaging applications.
The company has simultaneously announced a strategic partnership with American Regent (搜索) to commercialize the product in the United States. Under the agreement terms, Xeris will maintain responsibility for product supply, while American Regent will handle all commercialization efforts. Financial details of the partnership were not disclosed.
First Ready-to-Dilute Liquid Glucagon for Diagnostic Procedures
Gvoke VialDx (搜索) represents the first concentrated, ready-to-dilute liquid glucagon available for the procedural gastroenterology market. The product will be available as a 1-count or 10-count package of 1 mg per 0.2 mL single-dose vials, with market availability expected in the third quarter of 2025.
Kevin McCulloch, President and COO of Xeris, highlighted the product's potential impact: "Gvoke VialDx (搜索) has the potential to modernize the handling and administration of glucagon for diagnostic procedures. American Regent (搜索) is the perfect partner given their long history as a leading provider of high quality, sterile injectable products to the hospital and acute care marketplace."
The approval addresses a substantial market need, with an estimated 20 million gastrointestinal endoscopic procedures performed annually in the United States.
Clinical Application and Mechanism
During radiologic examinations, particularly those involving the gastrointestinal tract, temporary inhibition of intestinal movement is often necessary to obtain clear, diagnostic-quality images. Gvoke VialDx (搜索) is specifically indicated for intravenous use as a diagnostic aid to temporarily inhibit movement of the gastrointestinal tract in adult patients undergoing such examinations.
The product leverages Xeris' proprietary XeriSol (搜索) technology, which enables stable liquid formulations of peptides and proteins that traditionally require lyophilization or refrigeration.
Commercial Strategy and Market Potential
Joann Gioia, Vice President and Chief Commercial Officer at American Regent (搜索), expressed enthusiasm about the partnership: "We are eager to bring our commercial expertise in the hospital and acute care setting to our partnership with Xeris and contribute to the success of Gvoke VialDx (搜索). The addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need."
American Regent (搜索)'s established presence in hospital and acute care settings positions the company well to integrate Gvoke VialDx (搜索) into clinical practice workflows. The partnership leverages American Regent's distribution network and relationships with healthcare institutions, potentially accelerating adoption of the new formulation.
Safety Profile and Considerations
As with other glucagon products, Gvoke VialDx (搜索) carries specific contraindications and safety considerations. The product is contraindicated in patients with pheochromocytoma (搜索) due to the risk of substantial increases in blood pressure, in patients with insulinoma (搜索) because of hypoglycemia (搜索) risk, in those with prior hypersensitivity reactions to glucagon or excipients, and in patients with glucagonoma (搜索).
The most common adverse reactions reported in clinical trials for Gvoke VialDx (搜索) included nausea, dysgeusia, headache, dizziness, and hot flush. Healthcare providers should monitor diabetic patients for changes in blood glucose levels during treatment, as the product may cause hyperglycemia.
Cardiac monitoring is recommended in patients with cardiac disease during use of Gvoke VialDx (搜索), as it may increase myocardial oxygen demand, blood pressure, and pulse rate.
Expanding Xeris' Product Portfolio
This approval expands Xeris' commercial portfolio, which already includes Recorlev for endogenous Cushing's syndrome (搜索), Gvoke for severe hypoglycemia (搜索), and Keveyis for primary periodic paralysis. The company continues to leverage its proprietary formulation technologies, XeriSol (搜索) and XeriJect, across multiple therapeutic areas.
The approval of Gvoke VialDx (搜索) demonstrates Xeris' continued focus on developing innovative formulations that address unmet medical needs and improve clinical workflows. The company's pipeline includes additional development programs, including XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism.
Market Availability Timeline
Healthcare providers and institutions can expect Gvoke VialDx (搜索) to become available in the third quarter of 2025. The companies will be working on implementation strategies, including integration into hospital formularies and radiologic procedure protocols, ahead of the commercial launch.