Phathom Pharmaceuticals (PHAT) FDA Approvals

Phathom Pharmaceuticals' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Phathom Pharmaceuticals (PHAT). Over the past two years, Phathom Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as vonoprazan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Vonoprazan FDA Regulatory Timeline and Events

Vonoprazan is a drug developed by Phathom Pharmaceuticals for the following indication: For the Treatment of Heartburn Associated with Non-Erosive GERD. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Highlights - May 20,2026

• Drug: vonoprazan
• Announced Date: May 20, 2026
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc today highlighted the growing body of clinical and scientific research on vonoprazan, the active ingredient in VOQUEZNA® (vonoprazan), at Digestive Disease Week (DDW) 2026, held May 2–5, 2026 in Chicago, Illinois.

Phathom Pharmaceuticals highlighted new clinical and scientific research on vonoprazan, the key ingredient in VOQUEZNA, at Digestive Disease Week 2026 in Chicago from May 2–5. The company said the drug’s use continues to grow, with more than one million prescriptions filled in the U.S. since launch. VOQUEZNA is approved for adults with erosive esophagitis, heartburn linked to GERD, and H. pylori infection when used with antibiotics.

Phathom also pointed to progress in its development pipeline, including a Phase 2 study of vonoprazan for eosinophilic esophagitis, which began in November 2025. Early results from that trial are expected in 2027. The company said it expects to reach operating profitability in the second half of 2026 and is raising funds to support commercialization, research, and general operations.

Results - October 25,2025

• Drug: vonoprazan
• Announced Date: October 25, 2025
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc. announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-Erosive Reflux Disease (NERD) have been published in the American Journal of Gastroenterology.

Phathom Pharmaceuticals announced new results from its Phase 3 pHalcon-NERD-301 trial in the American Journal of Gastroenterology. The study focused on VOQUEZNA® (vonoprazan) tablets for patients with Non-Erosive Reflux Disease (NERD).

In the trial, 772 patients were randomly assigned to VOQUEZNA 10 mg, 20 mg, or placebo for four weeks. After that, VOQUEZNA groups continued treatment for 20 weeks, and placebo patients switched to VOQUEZNA.

Results showed rapid relief of nighttime GERD symptoms. Over 50% of VOQUEZNA patients had heartburn-free nights after the first dose, compared to 32% on placebo. These gains held through 24 weeks, with median heartburn-free nights above 70%.

Exploratory measures also improved. Patients reported lower nighttime symptom severity and fewer sleep disturbances throughout treatment.

VOQUEZNA was generally well tolerated, with low rates of mild side effects such as nausea and abdominal pain.

Provided Update - October 23,2025

• Drug: vonoprazan
• Announced Date: October 23, 2025
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc. announced its participation in the American College of Gastroenterology's (ACG) 2025 Annual Scientific Meeting, being held October 24-29 in Phoenix, Arizona.

Phathom Pharmaceuticals, Inc. will participate in the American College of Gastroenterology’s 2025 Annual Scientific Meeting, October 24–29 in Phoenix, Arizona. The company plans to highlight its growing leadership in gastrointestinal disease treatments.

Phathom’s Medical Affairs and Commercial teams will staff Exhibit Booth #214 from October 26–29, giving attendees a chance to learn about VOQUEZNA® (vonoprazan) tablets. On Monday, October 27 (3:45–4:30 pm MST), Dr. John Erik Pandolfino will lead a VOQUEZNA® product theater titled “Expert Insights on GERD Therapy: A Case-Based Approach with a First-in-Class Acid Suppressant.”

Phathom also provided an independent medical education grant for a hybrid Medscape program, “Decision Points in the Management of GERD,” held Saturday, October 25, featuring faculty Charles P. Vega, MD; Rena Yadlapati, MD; and Prakash Gyawali, MD.

Steve Basta, Phathom’s President and CEO, said ACG offers a valuable forum to share clinical insights, engage experts, and reinforce the company’s commitment to improving patient outcomes in GI disorders.

FDA approved - June 16,2025

• Drug: vonoprazan
• Announced Date: June 16, 2025
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets.

Phathom Pharmaceuticals announced that the FDA has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) to correctly show the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets. This update confirms that VOQUEZNA is entitled to NCE regulatory exclusivity until May 3, 2032.

This correction aligns the Orange Book listing with statutory requirements and reinforces the long-term commercial prospects for the first-in-class treatment. The clarification provides a stable regulatory framework for VOQUEZNA, ensuring that its exclusive market status in treating gastrointestinal conditions is maintained over its full period of protection.

FDA approved - June 6,2025

• Drug: vonoprazan
• Announced Date: June 6, 2025
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Phathom's Citizen Petition filed on December 11, 2024 and communicated the Agency's intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets, extending through May 3, 2032.

Phathom Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its Citizen Petition filed on December 11, 2024. The FDA stated its plans to update the Orange Book to correctly reflect a full 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets. This exclusivity period will now extend through May 3, 2032, ensuring that the drug receives proper recognition and protection as a first-in-class treatment. With this update, Phathom confirms that VOQUEZNA® will maintain its market exclusivity during this period, solidifying its competitive advantage in treating conditions such as heartburn and gastroesophageal reflux disease. This decision from the FDA supports the company’s ongoing efforts to secure market rights and highlights the value of VOQUEZNA® in the treatment of gastrointestinal diseases.

Data Presentation - April 28,2025

• Drug: vonoprazan
• Announced Date: April 28, 2025
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc announced that the company will present real-world data for its first-in-class treatment VOQUEZNA® (vonoprazan) at Digestive Disease Week® (DDW) being held May 3–6, 2025, in San Diego, CA.

Phathom Pharmaceuticals, Inc. will present new real-world data on its first-in-class treatment, VOQUEZNA® (vonoprazan), at Digestive Disease Week® (DDW) in San Diego, CA from May 3–6, 2025. The data focuses on how VOQUEZNA is being used in everyday clinical practice by U.S. patients diagnosed with gastroesophageal reflux disease (GERD), including both Non-Erosive and Erosive forms. Highlighting the treatment's unique benefits, the presentation aims to provide insights into patient characteristics and treatment patterns that differentiate VOQUEZNA from traditional proton pump inhibitors. Additionally, Phathom will showcase two sponsored posters on May 5, and host a Product Theater session, offering healthcare professionals a closer look at the real-world efficacy and potential role of VOQUEZNA in improving symptom control for GERD patients.

Regulatory Update - December 11,2024

• Drug: vonoprazan
• Announced Date: December 11, 2024
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals, Inc announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA).

Phathom Pharmaceuticals announced today that it has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA). The petition requests that the FDA correct the Orange Book listings for VOQUEZNA (vonoprazan) tablets to reflect the full 10‐year New Chemical Entity (NCE) exclusivity period, which ends on May 3, 2032. Phathom argues that since VOQUEZNA tablets contain the same active ingredient as the VOQUEZNA TRIPLE PAK and DUAL PAK products—which were granted a 10-year exclusivity period under the GAIN Act—all vonoprazan-based products should benefit equally. The company believes that the current listings do not accurately show the full period of exclusivity as mandated by law. The FDA is expected to review the petition and respond within 180 days from submission.

Provided Update - July 30,2024

• Drug: vonoprazan
• Announced Date: July 30, 2024
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

hathom Pharmaceuticals, Inc announces that effective immediately, CVS Caremark has added VOQUEZNA® (vonoprazan) tablets to its commercial formularies. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn.

Phathom Pharmaceuticals, Inc. announced that CVS Caremark has immediately added VOQUEZNA® (vonoprazan) tablets to its national formularies. This important step extends access to VOQUEZNA for over 26 million commercially insured members and ultimately more than 116 million lives across the United States. VOQUEZNA is the only FDA-approved potassium-competitive acid blocker available in the U.S. and is used to treat various forms of gastroesophageal reflux disease (GERD). It is approved for providing relief from heartburn linked to Non-Erosive GERD as well as for healing and maintaining treatment of Erosive Esophagitis, commonly known as Erosive GERD. The move also simplifies patient access by requiring a single step through a generic prescription proton pump inhibitor, offering a new effective treatment option for many individuals suffering from acid-related disorders.

FDA Approval - July 18,2024

FDA Approved

• Drug: vonoprazan
• Announced Date: July 18, 2024
• Indication: For the Treatment of Heartburn Associated with Non-Erosive GERD

Phathom Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults.

Phathom Pharmaceuticals announced that the FDA has approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. This decision comes after a successful Phase 3 trial that demonstrated a significant and rapid reduction in heartburn symptoms, marking a breakthrough for millions of patients.

In the pivotal study, patients treated with VOQUEZNA experienced a higher percentage of 24-hour heartburn-free days—45% compared to 28% in those who received a placebo. This innovative treatment is the first of its kind in over 30 years, offering a new class of acid suppression therapy. With Non-Erosive GERD affecting a large portion of the U.S. population, this approval gives healthcare providers a promising option to help patients achieve heartburn-free days and improved quality of life.