Vonoprazan Fumarate

This trial is the first large, placebo-controlled clinical trial of an acid suppression treatment in EoE Topline results for the double-blind 12-week treatment portion of the study are expected in Q4 of 2026 June 23, 2026 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced it has completed enrollment in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA® (vonoprazan) tablets as an investigational treatment for eosinophilic esophagitis (EoE) in adults. The study has enrolled 95 patients at 41 U.S. sites. Topline results are anticipated in the fourth quarter 2026. "The pHalcon-EoE-201 study reflects our commitment to advancing care for people living with GI diseases,” said Steve Basta, President and Chief Executive Officer at Phathom. “For many years, acid suppression with proton pump inhibitors (PPIs) has played an important role in the treatment of EoE. As the first large, placebo-controlled study of acid suppression therapy in EoE, the pHalcon-EoE-201 study is designed to evaluate whether vonoprazan may offer a new, oral, non-steroidal treatment option for patients with EoE and, if successful, could help inform our future development strategy in this growing indication.” "EoE remains a difficult disease to manage, with few approved therapies and a significant portion of patients relying on PPIs which are not FDA-approved for this indication," said Evan S. Dellon, MD, MPH, Professor of Medicine in the Division of Gastroenterology and Hepatology, and Director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, and principal investigator of the pHalcon-EoE-201 study. "Completing enrollment in this first large, placebo-controlled trial of an acid suppression treatment in EoE brings us closer to better understanding whether vonoprazan could offer a meaningful new option for patients." The pHalcon-EoE-201 study is a two-part, randomized, double-blind, placebo-controlled Phase 2 study. In Part 1, 95 adults with endoscopically confirmed EoE and dysphagia have been randomized evenly to receive VOQUEZNA 20 mg or placebo once daily for 12 weeks. Patients who complete Part 1 are eligible to enter Part 2, a 12-week extension phase in which all participants receive VOQUEZNA 20 mg once daily. If the Phase 2 pHalcon-EoE-201 study generates positive results, Phathom expects to discuss with FDA potential future development plans in EoE, including pediatric evaluation that could potentially support an extension of regulatory exclusivity. Eosinophilic esophagitis (EoE) is a chronic immune condition of the esophagus where white blood cells called eosinophils build up in the lining, causing inflammation and potential difficulty or painful swallowing, choking, or food impaction. Additional symptoms may include chest pain, heartburn, regurgitation, and vomiting. Although the exact cause is unknown, EoE is believed to be triggered by a variety of stimuli, including certain foods and environmental allergens. Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, inflammation of EoE can worsen and narrow the esophagus, further exacerbating symptoms. Proton pump inhibitor (PPI) acid suppression therapies are commonly used as a first-line therapy for treatment of EoE although none are FDA approved for this use. VOQUEZNA ® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the rights to vonoprazan for the U.S., Europe and Canada from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. Phathom Pharmaceuticals is a biopharmaceutical company focused on the commercialization and development of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. The content above comes from the network. if any infringement, please contact us to modify.

N-Zyme Biomedical, a clinical-stage company headquartered in Delaware, announced the initiation of a Phase II trial of fosamprenavir for laryngopharyngeal reflux (LPR), marking the first clinical test of a pepsin inhibitor in reflux disease and a direct challenge to the decades-long dominance of acid suppression as the therapeutic paradigm for this condition. The significance lies in the molecule’s mechanism: while proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) reduce gastric acid, they do not address pepsin, the proteolytic enzyme that research increasingly implicates as a primary driver of tissue damage in LPR and other extraesophageal reflux manifestations. Fosamprenavir, the molecule N-Zyme is repurposing, is a well-characterized antiretroviral prodrug with an established human safety profile from its prior use in HIV therapy – marketed by ViiV Healthcare/GSK as Lexiva/Telzir. After identifying its function as a pepsin inhibitor, N-Zyme has recently secured patents from both the US Patent and Trademark Office and the Japan Patent Office covering its use in reflux indications. The trial is led by Dr. Nikki Johnston at the Medical College of Wisconsin, who has published extensively on pepsin’s role in LPR pathology. Competitive context The reflux treatment landscape is currently being reshaped by the P-CAB class. Phathom Pharmaceuticals’ Voquezna (vonoprazan) is approved in the US for erosive GERD, non-erosive GERD, and H. pylori eradication, while Sebela Pharmaceuticals’ tegoprazan has an NDA under FDA review with a decision anticipated in January 2027 following positive Phase III TRIUMpH data. Both agents, however, share the same fundamental limitation as PPIs: they suppress acid without targeting pepsin, leaving a subset of patients — particularly those with LPR — without adequate symptom control. Cross-trial comparisons are limited by differences in patient populations and endpoint definitions, but N-Zyme’s pepsin-directed approach is mechanistically distinct from all current approved therapies and any known late-stage pipeline program. LPR, often called “silent reflux,” is characterized by symptoms including chronic cough, hoarseness, and throat clearing, and is notoriously difficult to treat with standard acid-suppressive regimens. The patient population that fails PPIs and P-CABs represents a commercially and clinically meaningful unmet need, though the precise size of the addressable LPR market remains difficult to quantify given chronic underdiagnosis. The Phase II trial is expected to generate efficacy and safety data that will determine whether the pepsin inhibition hypothesis translates into clinical benefit — a question that the field has lacked the tools to answer until now. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.