Gvoke HypoPen (glucagon auto-injectable rescue pen) / Xeris Biopharma - LARVOL DELTA

Diagnosis of LADA With GAD-65 Autoantibody in a Patient Presenting With Hypoglycemia: A Case Report (ENDO 2025) - "Despite discontinuing his long-acting injectable insulin following his last hospitalization and adjusting his oral hypoglycemic regimen—reducing metformin from 1,000 to 500 mg twice daily while continuing sitagliptin (Januvia) at 100 mg once daily—his hypoglycemia persisted, raising suspicion for an alternative diagnosis...This case supports the routine use and clinical utility of GAD-65 testing in patients with unexplained hypoglycemia or poor response to standard diabetes treatment, as early identification of LADA can lead to more appropriate management strategies and help prevent complications associated with misdiagnosis. Hypoglycemia not only presents immediate dangers to individuals with diabetes, but it also significantly increases the risk of cardiovascular events and mortality. Early detection, careful monitoring, and effective prevention strategies are essential components of diabetes management to reduce these risks and improve long-term health outcomes."

Case report • Clinical • Cardiovascular • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Xeris Biopharma Delivers Record Fourth Quarter and Full-Year 2024 Results; and Announces 2025 Guidance (Businesswire) - "Gvoke: Net revenue was $82.8 million for the year ended December 31, 2024 – an increase of approximately 24% compared to prior year...Recorlev: Net revenue was $64.3 million for the year ended December 31, 2024 – an increase of approximately 118% compared to prior year...Keveyis: Net revenue was $49.5 million for the year ended December 31, 2024 – a decrease of approximately 13% compared to prior year."

Commercial • CNS Disorders • Cushing’s Disease • Endocrine Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Glucagon: Delivery Advancements for Hypoglycemia Management. (PubMed, Int J Pharm) - "Recent developments include non-injectable methods like BAQSIMI® (Nasal glucagon) offers a user-friendly option, but stability, bioavailability, and rapid onset remain formulation hurdles...The synergy of patent innovation and clinical validation offers a glimpse into the transformative potential of glucagon delivery yet underscores the intricate path toward widespread adoption and improved diabetes care. Finally, this review will help the formulation scientist, clinicians, healthcare providers, and patient to manage hypoglycemia using glucagon."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders

Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia. (PubMed, Diabetes Ther) - "Baqsimi, Gvoke and Zegalogue had comparable high proportions of treatment success in reversing insulin-induced hypoglycemia. Baqsimi achieved a lower mean maximum blood glucose value, which may have implications for the re-establishment of euglycemia. These findings may help support patients, caregivers and health care providers in their decision-making process when discussing various ready-to-use glucagon treatment options."

Clinical • Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Managing Severe Hypoglycaemia in Patients with Diabetes: Current Challenges and Emerging Therapies. (PubMed, Diabetes Metab Syndr Obes) - "Novel formulations of glucagon include the nasal form, the Gvoke HypoPen which is a ready-to-deliver auto-injector packaged formulation and finally a glucagon analogue, Dasiglucagon...Thus, significant improvements including development of newer insulin analogues, insulin pump therapy, continuous glucose monitoring (CGM), sensor-augmented pump therapy and novel formulations of glucagon have all contributed to reducing and preventing hypoglycaemia in diabetic individuals. However, considerable challenges remain as not all patients have access to diabetes technologies and to the newer glucagon formulations to help reduce and prevent hypoglycaemia."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Use of glucagon in severe hypoglycemia is scarce in most countries, and has not been expanded by new ready-to-use glucagons. (PubMed, Diabetol Metab Syndr) - "The aims of this study were to evaluate the use of glucagon in persons with type 1 diabetes in several countries, and to investigate if the availability of new ready-to-use glucagons (Baqsimi, Gvoke, Zegalogue, years 2019 to 2021) has expanded the overall use of glucagon...The use of glucagon (any type) remains low, approximately 1/10 of persons with type 1 diabetes. We conclude that use of glucagon is scarce in most countries, and so far has not been expanded by new ready-to-use glucagons such as the ones considered in this study."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Indirect Treatment Comparison (ITC) of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia: Baqsimi, Gvoke, and Zegalogue (ADA 2022) - "Ten trials were included in the ITC, including 4 for Baqsimi, 3 for Gvoke, and 3 for Zegalogue. Baqsimi had comparable efficacy with Gvoke and with Zegalogue (Table), and all 3 treatments achieved high treatment success (>98%) in adults and children with diabetes. In adults, results from the combined T1D and T2D analysis were consistent with the T1D analysis, except a statistically significant faster time achieving treatment success observed for Baqsimi vs."

Metabolic Disorders • Severe Hypoglycemia

Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies. (PubMed, BMJ Open Diabetes Res Care) - P3 | "A ready-to-use GAI was non-inferior to GEK, with a similar tolerability profile. GAI is an effective, safe, and well-tolerated rescue treatment for severe hypoglycemia and is a viable alternative to GEK."

Clinical • Head-to-Head • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Dasiglucagon (Zegalogue) for severe hypoglycemia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

"$XERS Announces Approval of sNDA of Gvoke Kit for the Treatment of Severe Hypoglycemia" (@BioStocks)

sNDA • Severe Hypoglycemia

"$XERS Q1 Gvoke net sales $8.1M Cash, cash equivalent $136M" (@BioStocks)

"Or even Xers with explosive 🧨 sales with respect to its GVoke pen." (@whizkid1961)

"$XERS FY'20 Gvoke net sales $20.2M" (@BioStocks)

[VIRTUAL] Ready-to-use dasiglucagon injection as a fast and effective treatment for severe hypoglycaemia (EASD 2020) - P3 | "The median time to recovery was 10 min for dasiglucagon and 12 and 40 min for GlucaGen® and placebo, respectively... In conclusion, dasiglucagon 0.6mg was demonstrated to be a fast and effective treatment for severe hypoglycemia. The stability of dasiglucagon in aqueous formulation enables further development of dasiglucagon as a treatment option in the entire spectrum of mild, moderate and severe hypoglycemia. Clinical Trial Registration Number NCT03378635"

Metabolic Disorders • Severe Hypoglycemia

"Xeris' glucagon injection Gvoke gains heat with HypoPen auto-injector launch @FiercePharma https://t.co/nLZHlGZCZI" (@sstrumello)

"Xeris' glucagon injection Gvoke gains heat with HypoPen auto-injector launch | Fraiser Kansteiner via @FiercePharma #hypoglycemia @XerisPharma https://t.co/ww7uuBI1L5" (@AnalySource)

Hypoglycemia

Perceptions About Glucagon Delivery Devices for Severe Hypoglycemia: Qualitative Research With Patients, Caregivers, and Acquaintances. (PubMed, Clin Ther) - "This research suggests that patients with diabetes, caregivers, and acquaintances prefer a device that is simple, compact, and ready to use. Nasal glucagon was generally preferred over autoinjector glucagon primarily because it lacks a needle and it appears to be less complicated."

Clinical • Journal • Diabetes • Metabolic Disorders • Mood Disorders • Severe Hypoglycemia

[VIRTUAL] Dasiglucagon as a Fast and Effective Treatment for Severe Hypoglycemia in Children with Diabetes (ADA 2020) - "In this pediatric Phase 3 trial, ZP4207-17086, the clinical efficacy and safety of 0.6 mg dasiglucagon administered subcutaneously (SC) (same dose as adults) was compared to placebo and with reference to GlucaGen®...No safety concerns were raised for dasiglucagon within the trial. In conclusion, consistent with adult phase 3 trials this study demonstrated a fast, effective treatment response with a median time to recovery of 10 min in children ≥ 6 years, and an overall safety profile similar to glucagon."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia

[VIRTUAL] Dasiglucagon Hypopal Autoinjector as a Fast and Effective Treatment for Severe Hypoglycemia: Results of a Phase 3 Trial (ADA 2020) - P3 | "No safety concerns were raised for dasiglucagon.In conclusion, dasiglucagon 0.6mg SC administered via the HypoPal® auto-injector provided fast and effective recovery from hypoglycemia. The results are consistent with previously reported results from a pivotal phase 3 trial testing dasiglucagon administered via a pre-filled syringe, NCT03378635, where a median time to recovery of 10 min was also observed."

P3 data • Metabolic Disorders • Severe Hypoglycemia

[VIRTUAL] Dasiglucagon Hypopal Autoinjector as a Fast and Effective Treatment for Severe Hypoglycemia: Results of a Phase 3 Trial (ADA 2020) - P3 | "No safety concerns were raised for dasiglucagon.In conclusion, dasiglucagon 0.6mg SC administered via the HypoPal® auto-injector provided fast and effective recovery from hypoglycemia. The results are consistent with previously reported results from a pivotal phase 3 trial testing dasiglucagon administered via a pre-filled syringe, NCT03378635, where a median time to recovery of 10 min was also observed."

P3 data • Metabolic Disorders • Severe Hypoglycemia

[VIRTUAL] Evaluation of Attitudes towards Two Glucagon Delivery Devices for Rescue Treatment of Severe Hypoglycemia (ADA 2020) - "This study provides insights on PWDs’, CGs’ and AQs’ attitudes towards new glucagon devices, which may be considered when making product choices among the glucagon delivery systems."

Late-breaking abstract • Metabolic Disorders • Severe Hypoglycemia

Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation. (PubMed, Diabetes Technol Ther) - "The GAI and instructional materials can be correctly, safely, and effectively used by intended user, which support continued development of the GAI as an alternative to GEKs."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia

Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon (clinicaltrials.gov) - P2/3; N=30; Active, not recruiting; Sponsor: Steven J. Russell, MD, PhD; Trial primary completion date: Jul 2017 ➔ Dec 2017

Trial primary completion date • Biosimilar • Diabetes • Metabolic Disorders

Newly Approved Novel Dosage Forms of Glucagon for Management of Severe Hypoglycemia. (PubMed, Sr Care Pharm) - "Nasal glucagon and glucagon autoinjection "pens" are as effective as glucagon kits and increase the likelihood glucagon will be appropriately used by patient caregivers. The safety, efficacy, and convenience of these new devices may improve outcomes and reduce health care costs of older people with diabetes."

Journal

A ready-to-use liquid glucagon for treatment of severe hypoglycemia demonstrates reduced healthcare payer costs in a budget impact model. (PubMed, J Med Econ) - "Costs (USD) were obtained from the 2018 Medicare Fee Schedules and adjusted to represent commercial payer costs. GRP and G-PFS led to fewer EMS, ED, inpatient, and outpatient costs compared to GEK and no kit, resulting in total per-patient SHE costs of $2,564, $3,606, and $3,849, respectively. Costs for one million covered lives were almost $9 million versus $8.2 million following introduction of GRP and G-PFS.LIMITATIONS: The model is limited by reliance on assumptions based on expert opinion for key variables, primarily the probability of: 1) ambulance calls, 2) ambulance transport to the ED, and 3) non-ambulance transport to the ED. A budget impact model suggests GRP and G-PFS can lead to significant annual cost savings for US commercial payers."

HEOR • Journal