Clinical Trials & Pipeline
Phathom Pharmaceuticals is currently evaluating vonoprazan* (potassium-competitive acid blocker) vs. active comparator lansoprazole (proton-pump inhibitor) in a Phase 3 trial for the treatment of erosive GERD. We have initiated a Phase 2 trial evaluating vonoprazan on-demand in non-erosive reflux disease (NERD); in April 2021, Phathom shared the positive results of our Phase 3 trial for the treatment of H. pylori infection.
We believe that potassium-competitive acid blockers (P-CABs), such as vonoprazan, have the potential to become an important treatment alternative for the millions of patients for whom the current standard of care is insufficient.
Qol & Symptom Assessments:
PAGI-SYM, PAGI-Qol, EQ-5D-5L, Symptom diary
Diagnosis and healing of erosive esophagitis confirmed by endoscopy.
EQ-5D-5L = EuroQoL-5 Dimensions-5 Levels; PAGI QoL = Patient Assessment of Upper Gastrointestinal Disorders Quality of Life; PAGI SYM = Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index; QD = once daily.
Grading based on LA Classification system. Subjects will use an electronic diary twice daily to record the presence and maximum severity of daytime and nighttime heartburn symptoms.
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 Esophagitis, maintenance of Erosive Esophagitis, and H. pylori treatment conducted by Takeda.