Glucagon

First concentrated, ready-to-dilute liquid glucagon available for diagnostic procedures SHIRLEY, N.Y., Aug. 27, 2025 /PRNewswire/ -- American Regent, Inc.® is pleased to announce the commercial launch and availability of Gvoke VialDx™ (glucagon injection). Gvoke VialDx (glucagon injection) is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Gvoke VialDx (glucagon injection) vial The launch of Gvoke VialDx is the result of a partnership between American Regent and Xeris Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will be responsible for product supply, and American Regent will be responsible for the commercialization of Gvoke VialDx in the U.S. Joann Gioia, Vice President and Chief Commercial Officer at American Regent, said, "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. The addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need." "We're proud to mark the commercial launch of Gvoke VialDx in partnership with American Regent. Gvoke VialDx is the first liquid glucagon available for use as a diagnostic aid and provides an important new option for hospitals and clinics. American Regent is a natural partner to commercialize Gvoke VialDx given their longstanding reputation as a leading provider of high-quality sterile injectable products," said Kevin McCulloch, President and COO of Xeris. Gvoke VialDx will be available as a 1-count, or 10-count package of 1 mg per 0.2 mL single-dose vials and is available for immediate shipment. Customers can order the product through their wholesaler, distributor, or by contacting the American Regent Customer Support Group at 1-800-645-1706. Please see the Important Safety Information below. To view the Full Prescribing Information, please click here. For additional information on Gvoke VialDx, please visit . IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GVOKE VialDx is contraindicated in patients with: Pheochromocytoma, because of the risk of substantial increase in blood pressure Insulinoma, because of the risk of hypoglycemia Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension Glucagonoma, because of risk of hypoglycemia. WARNINGS AND PRECAUTIONS Substantial Increase in Blood Pressure in Patients with Pheochromocytoma GVOKE VialDx is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure. Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE VialDx is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously. Serious Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue GVOKE VialDx if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. GVOKE VialDx is contraindicated in patients with a prior hypersensitivity reaction to glucagon, or any of the excipients in GVOKE VialDx. Necrolytic Migratory Erythema (NME) NME, a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported post marketing following continuous glucagon infusion. GVOKE VialDx is not approved for continuous infusion. NME lesions may affect the face, groin, perineum, and legs or be more widespread. In the reported cases, NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Hyperglycemia With Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment with GVOKE VialDx and treat hyperglycemia, if indicated. Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease When Used as a Diagnostic Aid GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate, which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. Hypoglycemia in Patients with Glucagonoma GVOKE VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. GVOKE VialDx is contraindicated in patients with glucagonoma when used as a diagnostic aid. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously. ADVERSE REACTIONS Clinical Trials Experience The most common adverse reactions occurring in ≥5% of adult healthy volunteers who received 0.75 mg GVOKE VialDx intravenously were nausea, dysgeusia, headache, hot flush, and dizziness. Postmarketing Experience The following reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon Hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration DRUG INTERACTIONS Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE VialDx. Insulin acts antagonistically to glucagon. The concomitant use of anticholinergic drugs and GVOKE VialDx increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. GVOKE VialDx may increase the anticoagulant effect of warfarin. USE IN SPECIFIC POPULATIONS Pediatric Use Safety and effectiveness of GVOKE VialDx for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established. Geriatric Use Clinical studies of GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients. OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure, and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed. INDICATIONS AND USAGE GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Please see Full Prescribing Information. You are encouraged to report Adverse Drug Events to Xeris Pharmaceuticals, Inc. at 1-877-937-4737, or to the FDA by visiting , or by calling 1-800-FDA-1088. About American Regent American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit About Xeris Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous hypercortisolemia in patients with Cushing's syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris' technology platforms, XeriSol® and XeriJect®, for its partners. Xeris Biopharma Holdings, Inc. is headquartered in Chicago, IL. For more information, visit , or follow on X, LinkedIn, or Instagram. 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Pemvidutide is the only drug currently granted Fast Track Designation in AUD RECLAIM, a Phase 2 trial of pemvidutide in AUD, is currently enrolling GAITHERSBURG, Md., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD). Fast Track designation is intended to accelerate the development and review of new drugs that target serious conditions and address unmet medical needs. RECLAIM (NCT06987513), a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD, is currently enrolling. Approximately 100 patients will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days, with key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (WHO) risk drinking level and absolute change from baseline in average levels of phosphatidylethanol (PEth), a serum biomarker of alcohol intake. The trial began enrolling in May 2025. “Despite an estimated prevalence of AUD in more than 28 million adults in the U.S. alone, the scarcity of effective treatment options has created a sizeable treatment gap in AUD, with only 2% being treated with medication today,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “Currently approved therapies have shown limited effectiveness and fail to adequately address the comorbidities of AUD, such as hepatic steatosis, hyperlipidemia and hypertension, or other comorbidities of obesity from which individuals with AUD often suffer. The Fast Track designation recognizes both the urgent unmet need associated with AUD and the potential for pemvidutide to play a role in the treatment of this serious condition.” Scott Harris, M.D., Chief Medical Officer of Altimmune added, “There is a clear scientific rationale for the use of pemvidutide in AUD. Fatty liver develops in up to 90% of problem drinkers and places individuals with AUD at risk for alcohol-associated hepatitis. Treatment with GLP-1 agonists is recognized to reduce cravings for alcohol, while glucagon is recognized to reduce hepatic steatosis and inflammation. In a preclinical model of free-choice alcohol use, pemvidutide was shown to produce rapid and significant reduction in alcohol intake. We look forward to evaluating the potential of pemvidutide in the treatment of AUD through the ongoing RECLAIM trial.” Fast Track designation is designed to facilitate development and expedite the review of therapies with the potential to treat serious or life-threatening conditions that demonstrate the potential to address a major unmet medical need. Product candidates that receive Fast Track designation have the opportunity to benefit from early and frequent communication with the FDA and may be eligible for rolling submission and priority review of a New Drug Application (NDA). About AUD Alcohol use disorder (AUD) is a medical condition driven by an impaired ability to stop or control the harmful consumption of alcohol. Alcohol use disorder can also lead to serious downstream health consequences, including liver disease, cardiovascular disease, and cancer. Additionally, most patients with AUD have comorbid overweight or obesity and present with liver steatosis, further amplifying their risk for poor outcomes. The World Health Organization estimates that harmful alcohol consumption is the seventh leading cause of global death and disability, with alcohol accounting for 50% of all liver-related deaths. Today, it is estimated that 28 million adults in the U.S. suffer from AUD. Patients with AUD are characterized as mild, moderate or severe according to the DSM-5 criteria with approximately 12 million having moderate or severe forms of the disease. Only three drugs for AUD have been approved by the FDA, but these agents have limited efficacy for AUD and its comorbidities, and are used by less than 2% of patients. There is a substantial unmet need for new and more effective treatments that not only reduce alcohol cravings and heavy drinking days but also can address the numerous comorbidities of the disease. About Pemvidutide Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD) and obesity. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In the ongoing IMPACT Phase 2b trial, at Week 24, once-weekly pemvidutide demonstrated statistically significant MASH resolution without worsening of fibrosis, positive trends in liver fibrosis stage improvement without worsening of MASH, statistically significant reductions in non-invasive tests of fibrosis, weight loss, and liver fat content, and improvements in blood pressure. In a post-hoc AI-based analysis of the biopsies from the IMPACT trial, pemvidutide achieved a statistically significant reduction in liver fibrosis. In earlier trials, pemvidutide also demonstrated class-leading lean mass preservation and robust reductions in triglycerides and LDL cholesterol. Pemvidutide was well tolerated in the IMPACT trial, demonstrating potentially best-in-class tolerability among drugs in development for MASH with very low rates of discontinuation due to adverse events. The FDA granted Fast Track designation to pemvidutide for the treatment of MASH. The ongoing IMPACT Phase 2b MASH trial 48-week readout is expected in Q4 2025. In addition, RECLAIM, a Phase 2 trial in AUD, and RESTORE, a Phase 2 trial in ALD, were initiated in May 2025 and July 2025, respectively. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead product candidate is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD) and obesity. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Forward-Looking Statement Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing RECLAIM, RESTORE and IMPACT Trials, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD, ALD and obesity, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements, or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Company Contact: Greg Weaver Chief Financial Officer Phone: 240-654-1450 ir@altimmune.com Investor Contact: Lee Roth Burns McClellan Phone: 646-382-3403 lroth@burnsmc.com Media Contact: Jake Robison Inizio Evoke Comms Phone: 619-849-5383 jake.robison@inizioevoke.com This press release was published by a CLEAR® Verified individual. Source: Altimmune, Inc