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.
相关临床试验
25
12 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
2018
进行中（未招募）
11
44.0%
已完成
11
44.0%
尚未招募
1
4.0%
招募中
1
4.0%
撤回
1
4.0%
- Phathom Pharmaceuticals completed enrollment of 95 patients across 41 U.S. sites in its Phase 2 pHalcon-EoE-201 study of VOQUEZNA (vonoprazan) for eosinophilic esophagitis, with topline results expected in Q4 2026. - The trial is described as the first large, placebo-controlled clinical study of an acid suppression treatment in EoE, a disease where PPIs are used first-line but none carry FDA approval for this indication. - Vonoprazan, a potassium-competitive acid blocker (PCAB), offers more rapid and sustained acid suppression than conventional PPIs and is already approved for erosive GERD and H. pylori infection. - Positive Phase 2 results could establish the first placebo-controlled efficacy signal for the acid suppression drug class in EoE and pave the way for pediatric development and regulatory exclusivity extension.
- Phathom Pharmaceuticals has strategically pivoted from primary care to gastroenterology-focused sales for VOQUEZNA, the first potassium-competitive acid blocker approved in the U.S. for GERD. - The company generated $55 million in revenue in 2024 and estimates $175 million for 2025, targeting operating profitability in the second half of 2026. - CEO Steven Basta outlined plans to capture 20-30% of gastroenterology PPI prescriptions, potentially generating $1 billion in revenue from GI practices alone. - Phathom is developing an eosinophilic esophagitis program that could extend market exclusivity through pediatric studies, with current exclusivity running through May 2032.
- Braintree Laboratories submitted an NDA to the FDA on January 9, 2026, for tegoprazan, a novel potassium-competitive acid blocker (P-CAB) seeking approval for three GERD indications. - Phase 3 TRIUMpH program data from over 2,000 US patients demonstrated tegoprazan's statistical superiority over proton pump inhibitors in healing erosive esophagitis across all severity grades. - The drug showed rapid acid control within 45 minutes and superior sustained healing compared to lansoprazole, addressing unmet needs for 35-54% of GERD patients inadequately controlled by current therapies. - FDA approval is anticipated in January 2027, potentially making tegoprazan the first P-CAB to demonstrate superiority in EE healing across all LA grades versus PPIs.
- Phathom Pharmaceuticals published Phase 3 trial results for VOQUEZNA in the American Journal of Gastroenterology, showing significant improvement in heartburn-free nights versus placebo. - The pHalcon-NERD-301 study demonstrated that VOQUEZNA provided rapid relief from nocturnal GERD symptoms with sustained symptom relief over 20 weeks. - Patient-reported outcomes indicated the treatment was generally well tolerated with common mild adverse events in non-erosive reflux disease patients. - Wall Street analysts maintain positive outlook with four buy ratings and price targets ranging from $5.0 to $28.0, reflecting market interest in the clinical data.
- VOQUEZNA (vonoprazan) demonstrated significant improvement in nocturnal GERD symptoms in patients with Non-Erosive Reflux Disease, with 59.9% and 56.4% heartburn-free nights for 10mg and 20mg doses respectively versus 43.3% for placebo. - The first-in-class potassium-competitive acid blocker showed rapid onset of effect, with separation from placebo observed after the first dose and sustained relief maintained through 24 weeks of treatment. - Results from the Phase 3 pHalcon-NERD-301 trial, published in the American Journal of Gastroenterology, address a significant unmet need as nighttime GERD symptoms affect up to 80% of GERD patients. - The study involved 772 patients and demonstrated durable improvements in nocturnal symptom severity and sleep-related impacts throughout the full treatment period.
- 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 is a first-in-class potassium-competitive acid blocker (PCAB) currently marketed for treating heartburn associated with Non-Erosive GERD, healing and maintenance of Erosive GERD, and H. pylori infection in adults. - The regulatory exclusivity provides Phathom with significant market protection for their gastrointestinal disease treatment portfolio, including VOQUEZNA TRIPLE PAK and DUAL PAK formulations. - This FDA decision strengthens Phathom's competitive position in the acid-blocking therapy market and supports their commercialization strategy for vonoprazan-based treatments.
• 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.
• 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 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 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.
