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    • Press >
      • ​Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Completion of Enrollment of the Global Phase 2b Study Evaluating Naronapride in Gastroparesis (MOVE-IT)
      • Renexxion Ireland Ltd. Announces Issuance of Fifth New U.S. Patent Covering Novel Crystal Isoform of Naronapride
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
      • Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories
      • Renexxion to Present at the Oppenheimer 34ᵗʰ Annual Healthcare Life Sciences Conference
      • Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
      • Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD
      • Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
      • ​Renexxion to Present at the Oppenheimer Healthcare Private Company Showcase​
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis
      • Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
      • Gastrointestinal Biotech Company Renexxion Ireland Announces $100M Investment Commitment
      • Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders
      • Renexxion Ireland Ltd. Announces a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH
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Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders 

ROSCREA, Ireland 23rd December, 2021 /PRNewswire/ – Renexxion Ireland Ltd., a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need gastrointestinal (“GI”) disorders, announced today the issuance of a new US patent covering composition-of-matter of its lead drug candidate, naronapride, a unique late-stage GI prokinetic. The patent is also being prosecuted worldwide. Renexxion Ireland holds the worldwide rights to develop and commercialize naronapride.

  • The new US composition-of-matter patent extends the loss of exclusivity for naronapride to 2038, excluding any patent-term adjustment. 
  • Naronapride is currently being developed for commercialization initially for high unmet medical need in gastroparesis in Greater Europe (including UK), Russia, Central Asian Republics and certain Australasian countries by its European licensing partner. 
  • Renexxion Ireland is considering potential development and commercialization partners in other areas worldwide, such as Greater China, Japan, and, possibly, North America. 

Naronapride is a late-phase clinical stage drug candidate which possesses a unique combination of both serotonin 5HT4-receptor agonistic and dopamine D2-receptor antagonistic properties, both of which are clinically validated targets and work in both the upper and lower GI tract. Currently, the options to treat dysmotility disorders of the GI tract such as gastroparesis and other disorders such as IBS-c, GERD, and CIC, are limited. 

“The new patent enables the company to develop and commercialize naronapride for multiple gastrointestinal disorders requiring a prokinetic over the next two decades in order to establish it as a potential best-in-class prokinetic.” said Peter Milner M.D., FACC, Chairman and CEO. 

 
About unmet GI motility disorders 
No safe and effective GI motility agent is currently available to patients. The last such agents approved were cisapride (Propulsid®) and tegaserod (Zelnorm®), which each sold over $1Bn annually and were withdrawn over 10 years ago due to cardiac safety concerns.


About Naronapride – Potential best-in-class blockbuster for unmet GI indications 
Naronapride is a late-phase clinical stage drug candidate which possesses a unique combination of both 5HT4 agonistic and D2 antagonistic properties and works in both upper and lower GI. It is locally active in gut lumen, designed to be minimally absorbable, side-effect profile indistinguishable from placebo. Four positive Phase 2 studies completed in upper and lower GI indications and is Phase 3 ready in CIC (chronic idiopathic constipation) and GERD (gastro-esophageal reflux). Naronapride was engineered to avoid any cardiac safety risk. Its oral formulation serves large unmet needs in CIC, IBS-c, PPI-resistant GERD and gastroparesis. 

 
About Renexxion: 
Renexxion Ireland Ltd. is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI motility disorders with its operations and drug development team based in Ireland. For more information, refer to http://www.rnexltd.ie. 


Contact: 
Catherine Pearson, Chief Operating Officer, at [email protected], or on +353 61 539121. 
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  • Home
  • Company
    • Our Vision
    • Our Leadership Team
  • ​Naronapride (ATI-7505)
    • About Naronapride (ATI-7505)
    • Mechanism of Action
    • Development Status
    • Chemistry and Manufacturing
    • Regulatory Developments
  • Knowledge Centre
    • Gastrointestinal Dysmotility in Cystic Fibrosis (CF)
    • Gastroparesis
    • Chronic Idiopathic Constipation
    • Irritable Bowel Syndrome
    • PPI non-responsive GERD
  • News
    • Press >
      • ​Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Completion of Enrollment of the Global Phase 2b Study Evaluating Naronapride in Gastroparesis (MOVE-IT)
      • Renexxion Ireland Ltd. Announces Issuance of Fifth New U.S. Patent Covering Novel Crystal Isoform of Naronapride
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
      • Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories
      • Renexxion to Present at the Oppenheimer 34ᵗʰ Annual Healthcare Life Sciences Conference
      • Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
      • Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD
      • Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
      • ​Renexxion to Present at the Oppenheimer Healthcare Private Company Showcase​
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis
      • Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
      • Gastrointestinal Biotech Company Renexxion Ireland Announces $100M Investment Commitment
      • Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders
      • Renexxion Ireland Ltd. Announces a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH
  • Contact