Vogenx, a Raleigh, North Carolina, company developing drugs for metabolic and gastrointestinal disorders, announced on October 15, 2026 that it has initiated EMERGE, a Phase 2b trial of its investigational drug mizagliflozin in people who suffer repeated bouts of low blood sugar after weight-loss surgery. It is the first clinical milestone the company has reported since its August initial public offering, and it comes two months after a rival therapy for the same condition posted Phase 3 results. “Initiating EMERGE is an important milestone for Vogenx and for people living with post-bariatric hypoglycemia, a serious and often debilitating condition with no approved treatment options,” said James Green, Chief Executive Officer of Vogenx.
Inside the EMERGE Study
Post-bariatric hypoglycemia (PBH) is a chronic complication of bariatric surgery in which blood sugar drops sharply after meals, producing symptoms that can include shakiness, confusion and loss of consciousness. EMERGE aims to enroll about 36 adults whose surgery took place more than 12 months earlier. After a three-week run-in, participants will be randomized to mizagliflozin 5 mg, mizagliflozin 10 mg or placebo, taken by mouth three times a day for 28 days while their glucose is tracked continuously. The primary endpoint is the combined number of Level 2 and Level 3 hypoglycemic events, and Vogenx expects to run the study at roughly 10 U.S. sites. The trial’s ClinicalTrials.gov record (NCT07760961), last updated in August, listed the study as not yet recruiting, with primary completion estimated for October 2027. Vogenx has not said whether the first participant has been dosed.
How Mizagliflozin Works
Mizagliflozin blocks sodium-dependent glucose transporter 1 (SGLT1), the main protein responsible for absorbing dietary glucose in the small intestine. Approved SGLT2 inhibitors act in the kidney, but Vogenx designed mizagliflozin to stay largely within the gut, where the company says it slows sugar uptake and reduces secretion of insulin and glucose-dependent insulinotropic peptide (GIP). The company describes the molecule as first-in-class and says bariatric surgery patients often overexpress SGLT1 in the intestine, which speeds glucose absorption. “Patients with PBH can experience sudden, severe drops in blood sugar after meals that disrupt daily life and can be dangerous,” said William Wilkison, PhD, Chief Scientific Officer of Vogenx. “By reducing and delaying glucose absorption in the small intestine, mizagliflozin targets key drivers of the exaggerated insulin response that causes these episodes.” Vogenx holds worldwide rights to the drug outside Japan, Korea and Taiwan under a license from Kissei Pharmaceutical Co., Ltd. signed in December 2021.
What Earlier Studies Showed
Green pointed to the drug’s track record so far: “Mizagliflozin has been studied in more than 500 subjects across 10 clinical studies and has been shown to reduce Level 2 and Level 3 hypoglycemic events in clinical studies of patients diagnosed with PBH. EMERGE is designed to build on those earlier results in a larger, placebo-controlled parallel group setting, and we look forward to working with our investigators to advance enrollment.”
The PBH-specific evidence behind that statement comes from two small Phase 2 studies. In the second, known as Study 012 and reported in June 2024, 15 patients each cycled through two doses of mizagliflozin and placebo for seven days apiece under a single-blind design. Among the nine patients who became hypoglycemic on placebo, the two higher doses together raised the post-meal glucose low point by an average of 18 mg/dL (p=0.028), and peak glucose also fell significantly. The reduction in peak insulin did not reach statistical significance (p=0.074). Fewer hypoglycemic events were seen in an exploratory analysis: Level 3 events fell significantly at the 5 mg dose but not at 10 mg (p=0.07), and Level 2 events dropped 30.3% and 75.5% at the two doses without reported p-values. Diarrhea, mostly mild to moderate, was the most common side effect. EMERGE is the first of the company’s PBH studies to make hypoglycemic events the primary endpoint in a double-blind, parallel-group setting.
A Race Toward the First PBH Therapy
No drug is approved for PBH yet, but the field has moved quickly this year. On August 18, Amylyx Pharmaceuticals reported positive topline Phase 3 results for avexitide, a once-daily injectable GLP-1 receptor antagonist, in a 78-participant trial, and said it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2026. Recordati is developing pasireotide, a peptide injected before meals, while MBX Biosciences decided not to advance its candidate into Phase 2b. Vogenx is positioning mizagliflozin as the only oral option among them, although the regimen calls for three doses a day.
About Vogenx
Vogenx, Inc. (NASDAQ:VOGX) is a clinical-stage biopharmaceutical company based in Raleigh, North Carolina, focused on the discovery and development of novel therapeutics for the treatment of serious metabolic and gastrointestinal diseases with high unmet medical need. The Company is developing its lead product candidate, mizagliflozin, for post-bariatric hypoglycemia, gastroparesis and GIP-dependent Cushing’s Syndrome. For more information, please visit https://vogenx.com.
