FDA Events for Phathom Pharmaceuticals (PHAT)
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.
- Drug:
- vonoprazan
- Announced Date:
- June 16, 2025
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- vonoprazan
- Announced Date:
- June 6, 2025
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- vonoprazan
- Announced Date:
- April 28, 2025
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- vonoprazan
- Announced Date:
- December 11, 2024
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
Phathom Pharmaceuticals, Inc announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA).
AI Summary
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.
Read Announcement- Drug:
- vonoprazan
- Announced Date:
- July 30, 2024
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- vonoprazan
- Announced Date:
- July 18, 2024
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- vonoprazan
- Announced Date:
- May 15, 2024
- Indication:
- For the Treatment of Heartburn Associated with Non-Erosive GERD
Announcement
Phathom Pharmaceuticals, Inc. announced that the company will present data from multiple studies for its first-in-class treatment VOQUEZNA® (vonoprazan) including an oral presentation at Digestive Disease Week® (DDW) 2024, being held May 18-21 in Washington, D.C.
AI Summary
Phathom Pharmaceuticals, Inc. announced exciting news about its pioneering treatment, VOQUEZNA® (vonoprazan). The company will share important findings from several studies during an oral presentation at Digestive Disease Week® (DDW) 2024, which is scheduled to take place from May 18-21 in Washington, D.C. This event offers a prominent platform for the company to talk about the innovative clinical data supporting its first-in-class therapy.
The presentation is expected to highlight the potential of VOQUEZNA® in addressing unmet medical needs within the digestive disease community. By showcasing data gathered from multiple research studies, Phathom Pharmaceuticals aims to inform healthcare professionals about the advancements and therapeutic benefits of their novel treatment. This step underscores the company's commitment to transparency and progress in developing effective solutions for patients with gastrointestinal conditions.
Read Announcement
Phathom Pharmaceuticals FDA Events - Frequently Asked Questions
Yes, Phathom Pharmaceuticals (PHAT) has received FDA approval for vonoprazan. This page tracks recent and historical FDA regulatory events related to Phathom Pharmaceuticals' drug portfolio.
In the past two years, Phathom Pharmaceuticals (PHAT) has reported FDA regulatory activity for vonoprazan.
The most recent FDA-related event for Phathom Pharmaceuticals occurred on June 16, 2025, involving vonoprazan. The update was categorized as "FDA approved," with the company reporting: "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."
Currently, Phathom Pharmaceuticals has one therapy (vonoprazan) targeting the following condition: For the Treatment of Heartburn Associated with Non-Erosive GERD.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PHAT) was last updated on 7/11/2025 by MarketBeat.com Staff
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