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Vonoprazan
Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Phase III
Recruiting
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Aug 03, 2026
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Vonoprazan Odt-1 Or Odt-2 Without Water, Vonoprazan Odt-1 Or Odt-2 With Water, Vonoprazan
Healthy Volunteers
Phase I
Completed
A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants
Feb 14, 2025
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Vonoprazan
Erosive Esophagitis, Heartburn, Symptomatic Nonerosive Gasroesophageal Reflux Disease, Helicobacter Pylori Infection
Phase I
Completed
A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
Apr 25, 2024
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Vonoprazan
Gastroesophageal Reflux Disease
Phase I
Completed
A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease
Oct 24, 2023
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Vonoprazan
Gastroesophageal Reflux
Phase I
Completed
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Apr 18, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Phathom Pharmaceuticals (PHAT) have in its pipeline
PHAT is currently developing the following drugs: Vonoprazan, Vonoprazan, Vonoprazan Odt-1 Or Odt-2 Without Water, Vonoprazan Odt-1 Or Odt-2 With Water, Vonoprazan. These drug candidates are in various stages of clinical development as the company works toward FDA approval.