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Phathom Pharmaceuticals

Phathom Pharmaceuticals logo
🇺🇸United States
Ownership
Public
Established
2018-01-01
Employees
452
Market Cap
$1B
Website
http://www.phathompharma.com
Introduction

Phathom Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of novel treatments for gastrointestinal diseases. The company was founded by Tadataka Yamada, David Socks, Azmi Nabulsi, Aditya Kohli, and Roger Ulrich on January 9, 2018 and is headquartered in Florham Park, NJ.

Clinical Trials

24

Active:10
Completed:11

Trial Phases

3 Phases

Phase 1:18
Phase 2:2
Phase 3:3

Drug Approvals

2

FDA:2

Drug Approvals

VOQUEZNA

Approval Date
Nov 8, 2023
FDA

VOQUEZNA DUAL PAK

Approval Date
Nov 6, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (23 trials with phase data)• Click on a phase to view related trials

Phase 1
18 (78.3%)
Phase 3
3 (13.0%)
Phase 2
2 (8.7%)

A Study in Adult and Adolescent Participants With EoE to Evaluate Vonoprazan 10 mg and 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 10 mg and 20 mg Up to 52 Weeks

Phase 2
Not yet recruiting
Conditions
Eosinophilic Esophagitis
Interventions
Drug: Placebo
First Posted Date
2025-02-28
Last Posted Date
2025-02-28
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
150
Registration Number
NCT06851559

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

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Vonoprazan ODT-1 or ODT-2 without Water
Drug: Vonoprazan ODT-1 or ODT-2 with Water
Drug: Vonoprazan (Reference)
First Posted Date
2025-02-18
Last Posted Date
2025-04-16
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
25
Registration Number
NCT06831344
Locations
🇺🇸

7551 Metro Center Dr Ste 200, Austin, Texas, United States

A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Recruiting
Conditions
Erosive Esophagitis
Heartburn
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Helicobacter Pylori Infection
Interventions
First Posted Date
2024-10-28
Last Posted Date
2025-05-22
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
728
Registration Number
NCT06660342
Locations
🇺🇸

PPD, Wilmington, North Carolina, United States

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

Phase 1
Completed
Conditions
Erosive Esophagitis
Heartburn
Symptomatic Nonerosive Gasroesophageal Reflux Disease
Helicobacter Pylori Infection
Interventions
First Posted Date
2024-04-30
Last Posted Date
2025-03-25
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
15
Registration Number
NCT06391177
Locations
🇺🇸

PPD Development, LP, Las Vegas, Nevada, United States

A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease

Phase 1
Completed
Conditions
Gastroesophageal Reflux Disease
Interventions
First Posted Date
2023-10-30
Last Posted Date
2024-12-19
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Target Recruit Count
22
Registration Number
NCT06106022
Locations
🇺🇸

Strada Patient Care Center, Mobile, Alabama, United States

🇺🇸

Preferred Research Partners, Inc., Little Rock, Arkansas, United States

🇺🇸

Med Research Associates, Inc, Hollywood, Florida, United States

and more 10 locations
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News

FDA Grants Phathom Pharmaceuticals 10-Year Market Exclusivity for VOQUEZNA Through 2032

The FDA has approved Phathom Pharmaceuticals' Citizen Petition and will correct the Orange Book to recognize 10 years of New Chemical Entity exclusivity for VOQUEZNA (vonoprazan) tablets, extending through May 3, 2032.

VOQUEZNA Achieves $55.3M Revenue in First Full Year, Shows Strong Market Growth with 300,000 Prescriptions

• Phathom Pharmaceuticals' VOQUEZNA generated $55.3 million in net revenue during 2024, with Q4 sales reaching $29.7 million, marking an 81% increase from Q3. • The drug's market penetration expanded significantly with over 300,000 filled prescriptions to date and more than 20,000 healthcare providers prescribing the medication, demonstrating strong adoption in both gastroenterology and primary care settings. • Phathom is advancing VOQUEZNA's development program, including a planned Phase 2 trial for eosinophilic esophagitis (EoE) starting in Q2 2025, while maintaining broad commercial coverage reaching over 80% of U.S. commercial lives.

FDA Approves Phathom's Novel H. Pylori Treatments, Securing $260M Financing for Launch

• Phathom Pharmaceuticals receives FDA approval for two vonoprazan-based combination therapies - Voquezna Triple Pak and Voquezna Dual Pak - for treating H. pylori infections. • Clinical trials demonstrated superior efficacy of vonoprazan-based treatments, particularly in clarithromycin-resistant infections, with eradication rates up to 84.7% compared to 78.8% for standard therapy. • The company secures $260 million in non-dilutive financing to support product launches and continued development, with $100 million available immediately and $160 million tied to potential erosive esophagitis approval.

Phathom Pharmaceuticals Presents New VOQUEZNA® Data at ACG 2024

• Phathom Pharmaceuticals presented data at ACG 2024 highlighting VOQUEZNA's efficacy for Non-Erosive GERD, including on-demand use and nocturnal symptom relief. • A post-hoc analysis of the PHALCON-NERD-201 trial showed that as-needed VOQUEZNA effectively relieved episodic heartburn in Non-Erosive GERD patients. • Data from a nocturnal GERD study demonstrated VOQUEZNA's ability to significantly improve heartburn-free nights and reduce nocturnal GERD symptom severity. • VOQUEZNA, a potassium-competitive acid blocker, is FDA-approved for various GERD treatments and H. pylori eradication.

Phathom Pharmaceuticals Presents New VOQUEZNA® Data for GERD Treatment at ACG 2024

• Phathom Pharmaceuticals presented data on VOQUEZNA® (vonoprazan) at the ACG 2024 meeting, highlighting its efficacy in treating GERD. • A post-hoc analysis of the PHALCON-NERD-201 trial showed that on-demand VOQUEZNA provided rapid relief of heartburn in Non-Erosive GERD patients. • Data from another study indicated VOQUEZNA significantly improved nocturnal GERD symptoms, offering better sleep quality for patients. • These findings support VOQUEZNA's potential as a versatile treatment option for both daytime and nighttime GERD symptoms.

Phathom Pharmaceuticals Presents Positive VOQUEZNA® Data for GERD Treatment at ACG 2024

• Phathom Pharmaceuticals presented data on VOQUEZNA® (vonoprazan) at the ACG 2024 meeting, highlighting its efficacy in treating GERD. • A post-hoc analysis of the PHALCON-NERD-201 trial showed that on-demand VOQUEZNA provided rapid relief of heartburn in Non-Erosive GERD patients. • Data from another study indicated that VOQUEZNA significantly improved nocturnal GERD symptoms, offering better sleep quality for patients. • These findings support VOQUEZNA's potential as a versatile treatment option for both daytime and nighttime GERD symptoms.

FDA Approves Voquezna (vonoprazan) for Heartburn Relief in Non-Erosive GERD

• The FDA has approved Voquezna (vonoprazan) 10 mg tablets for heartburn relief associated with Non-Erosive GERD in adults, marking a new option for millions. • Voquezna demonstrated a significant reduction in heartburn episodes in a Phase 3 trial, offering more 24-hour heartburn-free days compared to placebo. • The approval is based on the PHALCON-NERD-301 study, which showed Voquezna's efficacy and safety over a four-week treatment period. • Voquezna, a potassium-competitive acid blocker (PCAB), is now available by prescription and represents a novel approach to acid suppression therapy.

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