Vonoprazan Fumarate

First patient dosed, with topline results expected in 2027 pHalcon-EoE-201 is the first large, well-controlled clinical trial of an acid secretory treatment in EoE Nov. 04, 2025 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the first patient has been dosed in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA® (vonoprazan) tablets as an investigational treatment for eosinophilic esophagitis (EoE) in adults. “The initiation of the pHalcon-EoE-201 study reflects Phathom’s commitment to advancing care for patients with gastrointestinal diseases and our development strategy to expand VOQUEZNA’s clinical potential,” said Steve Basta, President and Chief Executive Officer at Phathom. “This trial represents an important opportunity to address significant unmet needs in the treatment of EoE while potentially generating data to support discussions on a pediatric program that could ultimately extend VOQUEZNA’s regulatory exclusivity and strengthen our long-term growth strategy as leaders in GI.”“Despite advances in understanding eosinophilic esophagitis, treatment options remain limited, with only two approved therapies currently available,” 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. “Proton pump inhibitors (PPIs) are traditionally used as first-line treatment for EoE, but none are FDA approved for this indication, and supporting data come primarily from uncontrolled studies. VOQUEZNA’s acid suppression profile could potentially offer an oral, non-steroidal treatment approach for patients with EoE.” Phathom’s Phase 2 EoE study is a two-part, randomized, double-blind, placebo-controlled study. The first part will enroll 80 adults with endoscopic-confirmed EoE and dysphagia, or trouble swallowing, to be randomized evenly to receive VOQUEZNA 20 mg or placebo, once daily for 12 weeks. Patients who complete the initial 12-week treatment period will be eligible to enter Part 2, a 12-week extension phase, where all subjects will receive VOQUEZNA 20 mg for the remainder of the study. Topline primary and secondary results are anticipated to be available in 2027. pHalcon-EoE-201 (NCT06851559) is a Phase 2, randomized, double-blind, placebo-controlled study evaluating VOQUEZNA® (vonoprazan) 20 mg in approximately 80 adults with eosinophilic esophagitis (EoE) across approximately 40 U.S. sites. In Part 1, participants with endoscopically-confirmed EoE and dysphagia will receive once-daily VOQUEZNA or placebo for 12 weeks. Those who complete Part 1 may enter Part 2, a 12-week extension period, during which all patients will receive VOQUEZNA 20 mg once daily. 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 also include chest pain, heartburn, regurgitation, and vomiting. Although the exact cause is unknown, it 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, the inflammation of EoE can worsen and narrow the esophagus, further exacerbating symptoms. 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 development and commercialization 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.