Renexxion Secures Sixth U.S. Patent for Naronapride Trihydrate Formulation Targeting Multiple GI Disorders
核心洞察
Renexxion Ireland Limited (搜索) received its sixth U.S. patent (No. 12,391,684) covering a trihydrate crystal form of naronapride and related dosage forms for treating various gastrointestinal disorders.
The patent encompasses methods of use for a broad spectrum of GI conditions including GERD, gastroparesis (搜索), IBS, constipation (搜索), and functional dyspepsia (搜索), strengthening the company's intellectual property portfolio.
Naronapride, a dual-acting serotonin 5-HT4 receptor (搜索) agonist and dopamine D2 receptor (搜索) antagonist, has completed five Phase 2 studies with Phase 2b gastroparesis (搜索) results expected in Q1 2026.
Renexxion Ireland Limited (搜索) announced that the United States Patent and Trademark Office has granted its sixth U.S. patent for naronapride, marking a significant milestone in the company's intellectual property strategy for gastrointestinal therapeutics. Patent No. 12,391,684 covers a pharmaceutical composition containing a trihydrate crystal form of naronapride, along with related dosage forms and treatment methods for multiple GI disorders.
Comprehensive Patent Coverage for GI Disorders
The newly granted patent encompasses methods of use across an extensive range of gastrointestinal conditions, including gastroesophageal reflux disease (搜索) (GERD), functional dyspepsia (搜索) and functional motility disorders, gastroparesis (搜索), paralytic and post-operative ileus, nausea and emesis, heartburn, intestinal pseudo obstruction, irritable bowel syndrome (搜索) (IBS), constipation (搜索), enteral feeding intolerance (EFI), esophagitis, gastritis, megacolon, gastrointestinal stasis, and abomasal emptying defect.
"This patent reflects the strength of our science and continued focus on building meaningful intellectual property around naronapride," said Dr. Pascal Druzgala, PhD, Co-founder, Director and Chief Scientific Officer of Renexxion. "By expanding protection for a new formulation and related dosage forms, we are strengthening our ability to support development; with the ultimate goal of delivering improved options for patients who need superior treatments for debilitating GI conditions."
Naronapride's Dual Mechanism of Action
Naronapride represents Renexxion Ireland's flagship program for gastrointestinal disorders, developed to address critical unmet needs in both the upper and lower GI tract. The compound functions as a dual acting agent with serotonin 5-HT4 receptor (搜索) agonist and dopamine D2 receptor (搜索) antagonist effects, designed for minimal systemic absorption with local activity in the gut lumen to help optimize efficacy and safety.
The drug candidate is positioned as a potential best-in-class, orally administered pan-GI prokinetic agent, addressing the significant unmet medical needs faced by patients with limited safe and effective treatment options currently available.
Clinical Development Progress
Naronapride has completed five Phase 2 clinical studies to date, including the most recent global Phase 2b study in gastroparesis (搜索), with full study readout expected in Q1 2026. The company's clinical pipeline includes a Phase 2b study in proton pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (搜索) (PPI nrsGERD) anticipated to launch over the next 12 months. Additionally, Renexxion is preparing for Phase 3 trials in chronic idiopathic constipation (搜索) (CIC).
Strategic IP Portfolio Expansion
"This patent supports Renexxion's development strategy for naronapride across a broad range of GI disorders," said Dr. Peter Milner, M.D., FACC, Chairman and CEO of Renexxion. "We remain focused on advancing naronapride to market, for patients who continue to face significant unmet medical needs and limited safe and effective treatment options."
The pharmaceutical composition, dosage form, and treatment method patent forms part of a comprehensive intellectual property portfolio covering naronapride. The company is also pursuing patent protection in other countries, including Europe, Japan, and Greater China, demonstrating its global commercialization strategy.
Company Focus and Pipeline
Renexxion Ireland Limited (搜索), a wholly owned subsidiary of California-based Renexxion, Inc., operates as a privately held biopharmaceutical company committed to developing innovative treatments for GI disorders. Beyond naronapride development, the company is advancing a research program focused on developing drug candidates for inflammatory bowel disease (搜索) (IBD) through novel protein drug conjugates.