Renexxion Ireland

What Renexxion Ireland does

Renexxion Ireland Limited is a privately held biopharmaceutical company and a wholly owned Irish subsidiary of California-based Renexxion, Inc., headquartered in Limerick, Ireland, with additional operations in Roscrea. The company is focused on the late-stage clinical development of a single core asset, naronapride (ATI-7505), a small-molecule pan-GI prokinetic drug candidate that combines serotonin 5HT4 receptor agonism with dopamine D2 receptor antagonism. It was designed to be minimally absorbable and locally active in the gut lumen, with the goal of providing efficacy across both upper and lower GI indications while avoiding the cardiac safety issues that led to the market withdrawal of precedent drugs such as cisapride and tegaserod.

The company has completed eleven clinical studies covering more than 1,000 subjects, including a 328-patient global Phase 2b MOVE-IT trial in gastroparesis that met its primary endpoint with statistically significant symptom improvement versus placebo and a side-effect profile indistinguishable from placebo. Based on these results, the company and its European partner announced advancement of naronapride into pivotal Phase 3 studies in June 2026, with plans to file a New Drug Application with the FDA for US approval. The asset has been positioned for multiple indications with high unmet need, including gastroparesis, chronic idiopathic constipation, IBS-c, PPI-non-responsive symptomatic GERD, and GI dysmotility in patients with cystic fibrosis, with FDA IND clearance obtained for gastroparesis (via the partner's MOVE-IT expansion), PPI-non-responsive GERD, and CF dysmotility.

Renexxion Ireland operates a partnership-driven business model. Under a 2021 licensing and collaboration agreement with Dr. Falk Pharma GmbH, Renexxion out-licensed development and commercialization rights for Greater Europe (including the UK), Russia, the Central Asian Republics, and certain Australasian countries in exchange for up-front payments, development funding, milestone payments, and double-digit tiered royalties, while retaining rights for the United States, Japan, and Greater China. The company has secured six US patents covering naronapride composition-of-matter, novel crystal isoforms, and a trihydrate formulation, with composition-of-matter exclusivity extending to 2038, and holds a $100 million share subscription commitment from GEM Global Yield LLC SCS to be drawn following a future public listing. No commercial product revenue is currently generated.

Name

Renexxion Ireland

Legal name

Renexxion Ireland Limited

Website

https://rnexltd.ie

Company type

Private

Founded year

1901

Operating status

Operating

Headcount range

1–10 employees

Short description

Renexxion Ireland Limited is a privately held, Irish subsidiary biopharmaceutical company developing naronapride (ATI-7505), a late-stage pan-GI prokinetic drug candidate for gastroparesis, GERD, and related motility disorders, in partnership with Dr. Falk Pharma for non-US geographies.

Ownership category

akta.pro rank

Product category

Gastrointestinal Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Gastroenterology Specialty Pharmaceuticals (HLAIACAE)

akta.pro secondary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Gastrointestinal drug development
• GI prokinetic drugs
• Clinical stage biopharmaceuticals
• Pharmaceutical licensing
• GI motility disorders

Headquarters

HQ city

Limerick

HQ country

Ireland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Product Sales: Post-approval revenue from naronapride sales. Renexxion retains rights for US, Japan, and Greater China while Dr. Falk Pharma commercializes in Greater Europe.
2. Licensing and Milestone Payments: Up-front payments, development funding, clinical and regulatory milestone payments, and sales milestone payments plus double-digit tiered royalties from Dr. Falk Pharma partnership.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Renexxion Ireland is a privately held biopharmaceutical company developing a single late-stage clinical drug candidate, naronapride (ATI-7505), a pan-GI prokinetic with dual 5HT4 agonistic and D2 antagonistic mechanism designed for minimal systemic absorption. The company is advancing naronapride through Phase 3 development for gastroparesis and other GI motility indications (CIC, IBS-c, PPI-resistant GERD, cystic fibrosis GI dysmotility), out-licensing commercialization to Dr. Falk Pharma in Greater Europe while retaining rights in the US, Japan, and Greater China.

Product overview

Renexxion Ireland is a privately held biopharmaceutical company developing a single core drug product, naronapride (ATI-7505), as a potential best-in-class pan-GI prokinetic for multiple gastrointestinal indications with high unmet medical needs. The company collaborates with European partner Dr. Falk Pharma for development and commercialization in Greater Europe and certain Australasian countries while retaining rights for Greater China, United States, and Japan. Naronapride is in late-stage clinical development with five completed Phase 2 studies and advancing toward Phase 3 for gastroparesis and PPI non-responsive symptomatic GERD.

Differentiator

Problem solved

Functional benefit

Products and services

• Naronapride (ATI-7505) A potential best-in-class pan-GI prokinetic drug candidate with a dual mechanism of action combining serotonin 5HT4 receptor agonistic and dopamine D2 receptor antagonistic properties. Designed for minimal systemic absorption and local activity in the gut lumen, intended to treat upper and lower GI motility disorders including gastroparesis, chronic idiopathic constipation (CIC), IBS-c, PPI-resistant GERD, and GI dysmotility in cystic fibrosis patients.

Quantifiable outcome

• Phase 2b MOVE-IT trial met primary endpoint with statistically significant improvement in gastroparesis symptoms versus placebo
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Dr. Falk Pharma GmbHcoreStrategic or Co-development Partner · 5 October 2021Licensing and collaboration agreement for joint development and commercialization of naronapride. Dr. Falk Pharma handles Greater Europe (including UK), Russia, Central Asian Republics, and certain Australasian countries. Dr. Falk Pharma provides up-front payment, development funding, and milestone payments plus double-digit tiered royalties. Renexxion retains US, Japan, and Greater China rights. Dr. Falk Pharma has over 60 years of GI drug development experience with headquarters in Freiburg, Germany and approximately 990 employees globally.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• Processa Pharmaceuticals: Processa is a clinical-stage company developing drugs for GI disorders and other conditions. Its late-stage GI pipeline and small-cap profile position it as a closely comparable emerging peer in the GI motility space.
• RedHill Biopharma: RedHill is a specialty pharma with commercialized GI products including Talicia (H. pylori) and Aemcolo (travelers' diarrhea). Its mid-stage GI specialty profile and US commercialization experience make it a relevant emerging peer.
• CinDome Pharma: CinDome Pharma is developing prucalopride, another 5HT4 agonist prokinetic, for gastroparesis. It is one of the closest emerging clinical-stage competitors to naronapride in mechanism and indication.

Direct peers

• Theravance Biopharma: Theravance Biopharma developed velusetrag, a selective 5HT4 receptor agonist prokinetic for gastroparesis and CIC. Its mechanism overlaps directly with naronapride's 5HT4 component, making it a close mechanistic and indication peer.
• Evoke Pharma: Evoke Pharma is a US specialty pharma focused on gastroparesis with Gimoti (metoclopramide nasal spray). It is the most direct US-listed peer given Renexxion's lead gastroparesis indication and similar clinical-stage positioning.

Broad incumbents

• Takeda Pharmaceutical: Takeda is a global pharma major with a substantial GI franchise and historical involvement with cisapride. As a broad incumbent with deep GI commercial infrastructure, it shapes the competitive environment for any new prokinetic entrant.
• AbbVie: AbbVie holds commercial rights to Linzess (via the Allergan acquisition) and other GI products. As a top-tier pharma with significant GI resources, it represents a major incumbent competitor across multiple GI indications Renexxion is pursuing.
• Ironwood Pharmaceuticals: Ironwood commercializes Linzess (linaclotide) for CIC/IBS-c, a core GI motility indication Renexxion is also pursuing. As an established GI specialty player with US commercial infrastructure, Ironwood represents the incumbent naronapride would compete against in CIC.
• Bausch Health (Salix Pharmaceuticals): Salix Pharmaceuticals, a Bausch Health company, is a US leader in GI specialty products. Its large GI salesforce and established gastroenterology relationships position it as a key incumbent competitor in the US market Renexxion is targeting.

Others

• Dr. Falk Pharma GmbH: Dr. Falk Pharma is Renexxion Ireland's exclusive European licensing and development partner for naronapride. As an adjacent ecosystem participant and 60+ year GI specialist, it is included as a key strategic partner rather than a competitive peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/renexxion

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Renexxion Ireland