Renexxion - Ireland
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  • ​Naronapride (ATI-7505)
    • About Naronapride (ATI-7505)
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    • Development Status
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    • 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

Development Status

More than 900 subjects have been treated with naronapride in clinical trials, including three Phase-2 trials, where naronapride showed efficacy in both lower and upper GI indications.

A Thorough QT (TQT) study testing the cardiac safety of naronapride has also been completed. The results confirmed the cardiac safety profile of naronapride at both therapeutic and supra-therapeutic doses.

Renexxion Ireland has entered into a Licensing and Collaboration Agreement with Dr Falk Pharma GmbH to jointly develop and commercialise Naronapride in Greater Europe, Russia, Central Asian Republics and parts of Australasia. This partnership will commence with Phase 2 development for the initial indication, gastroparesis.  (More...)
 
With a vision of becoming a leading GI biopharmaceutical company globally, our agreement with Dr Falk Pharma will serve as an important catalyst in future worldwide development of Naronapride, including across Greater China, the United States and Japan. We plan to engage with pharmaceutical companies in these regions to explore potential future licensing and collaboration partnerships.

​Renexxion Ireland is committed to ongoing research and development in Ireland, forming a key part of the company’s strategy to lead the way in the GI biopharmaceutical space.
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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