Clinical Trials & Pipeline
Phathom Pharmaceuticals is currently advancing its development program across multiple acid-related GI disorders, including H. pylori infection, erosive GERD (erosive esophagitis), and non-erosive GERD (NERD).
Our Late-Stage Clinical Trials & Pipeline
Phathom has development and commercialization rights to vonoprazan in the United States, Europe, and Canada
1Phase 1 and 2 studies supporting application for healing of erosive GERD, maintenance of healing of erosive GERD, and H. pylori treatment conducted by Takeda
pHalcon-EE Trial Overview:
Phase 3 trial in US and Europe
Primary Endpoints:
• Healing Phase: Number of participants who have complete healing of erosive GERD by Week 8
• Maintenance Phase: Number of participants who maintain complete healing of erosive GERD until Week 24
Notes:
• Diagnosis and healing of erosive GERD confirmed by endoscopy
• Grading based on LA Classification system. Subjects used an electronic diary twice daily to record the presence and maximum severity of daytime and nighttime heartburn symptoms
www.ClinicalTrials.gov, NCT04124926
pHalcon HP Trial Overview:
Phase 3 trial in US and Europe
Primary Endpoint:
• Number of participants with successful HP eradication after treatment, excluding participants with clarithromycin or amoxicillin HP resistant strains at baseline
Notes:
• Diagnosis of infection and test of cure confirmed by 13C-urea breath test
• Dosing: Vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, lansoprazole 30 mg
• HP, Helicobacter pylori; BID, twice daily; TID, three times daily
www.ClinicalTrials.gov, NCT04167670
Visit our clinical trial sites to learn more:
Expanded Access Policy:
At Phathom, we work every day to improve the lives of people impacted by gastrointestinal diseases and to make therapies available to patients as quickly and safely as possible. Expanded access, also referred to as compassionate use, is a channel through which the US Food and Drug Administration (FDA) allows patients to receive investigational medicines in certain circumstances outside of the context of a clinical trial.
We do not currently make any of our investigational products available through expanded access programs, as we believe that our clinical trials are the most appropriate way to access our investigational products. We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Information about all of our trials, including enrollment status, eligibility criteria, and locations, is available at ClinicalTrials.gov.
To the extent we determine that expanded access to any of our investigational therapies becomes appropriate in the future, this website and policy will be updated to include information regarding the criteria to be used to evaluate these requests, among other information. If you have further questions, please contact our Medical Information team. We anticipate that your inquiry will be acknowledged within 5 business days.
Phathom Pharmaceuticals is going beyond the expected and working to change the GI treatment landscape for millions of patients suffering from acid-related disorders.
*Vonoprazan is a product candidate that is under clinical study and that has not been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of vonoprazan.
¹Phase 1 and 2 studies in healing of erosive GERD, maintenance of erosive GERD, and H. pylori treatment conducted by Takeda.