Eupraxia Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Eupraxia Pharmaceuticals (EPRX).
Over the past two years, Eupraxia Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EP-104GI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EP-104GI FDA Regulatory Timeline and Events
EP-104GI is a drug developed by Eupraxia Pharmaceuticals for the following indication: For Treatment of Eosinophilic Esophagitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EP-104GI
- Announced Date:
- September 29, 2025
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc today provided an operational update on the development of EP-104GI, including reporting data from patients in Cohort 9 of the dose escalation portion of the RESOLVE trial, the first time that patients received an 8mg dose per injection.
AI Summary
Eupraxia Pharmaceuticals reported first clinical data from Cohort 9 in the dose‐escalation phase of its RESOLVE trial, marking the first time patients received an 8 mg dose per injection of EP-104GI. This 8 mg dose is the highest tested so far and showed the greatest improvements in tissue health and the largest reduction in eosinophils to date.
No Serious Adverse Events or cases of candidiasis were observed in Cohort 9, reinforcing the safety profile of the 8 mg dose. These results led the RESOLVE Safety Committee and the Eupraxia Clinical Advisory Board to endorse 8 mg per injection as the second active dose for the ongoing Phase 2b study.
Eupraxia plans to expand the Phase 2b trial from 60 to at least 120 patients to boost statistical power, safety data, and the chance of breakthrough status. The company also aims to start a new GI indication trial in the first half of 2026.
A live webinar with further details will be held on October 1 at 8 am PDT (https://lifescievents.com/event/fk30t7wg2n/).
Read Announcement- Drug:
- EP-104GI
- Announced Date:
- July 8, 2025
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc. announced the first patient dosed in the Phase 2b randomized, placebo-controlled portion of the RESOLVE clinical trial evaluating EP-104GI, an investigational treatment for eosinophilic esophagitis ("EoE").
AI Summary
Eupraxia Pharmaceuticals Inc. announced that the first patient has been dosed in the Phase 2b randomized, placebo-controlled portion of the RESOLVE trial. This trial evaluates EP-104GI, an investigational treatment designed to address eosinophilic esophagitis (EoE) by injecting the drug directly into the esophageal tissue. The Phase 2b study will enroll at least 60 patients across up to 25 sites globally and will compare two active doses of EP-104GI with a placebo. The study will measure improvements in tissue health using biopsy scores (EoEHSS and PEC) and track symptom changes with patient-reported outcomes over a 12-month period. The dose levels for this part of the trial were chosen based on favorable safety and efficacy data gathered from the previous Phase 2a study. These steps are vital before moving on to pivotal clinical trials needed for regulatory approval.
Read Announcement- Drug:
- EP-104GI
- Announced Date:
- May 5, 2025
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc. announced positive treatment outcomes from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").
AI Summary
Eupraxia Pharmaceuticals Inc. shared promising news from its RESOLVE Phase 1b/2a trial testing EP-104GI for treating eosinophilic esophagitis (EoE). Notably, nine-month results reveal that all patients who received a 48 mg dose experienced sustained or improved treatment outcomes. The drug showed continuous, active release into the esophagus at rates consistent with the earlier 3- and 6-month marks. Patients reported reduced symptoms and notable improvements in tissue health, with significant decreases in eosinophil counts. These findings suggest that EP-104GI may provide a lasting effect, potentially supporting tissue remodeling in the esophagus, which could help manage the long-term inflammation and symptoms associated with EoE. Eupraxia plans to release additional long-term data with higher doses in Q3 2025, further exploring EP-104GI’s potential to enhance treatment options for patients with EoE.
Read Announcement- Drug:
- EP-104GI
- Announced Date:
- May 5, 2025
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc announced positive treatment outcomes from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").
AI Summary
Eupraxia Pharmaceuticals Inc. announced promising outcomes from its ongoing RESOLVE Phase 1b/2a trial, which is testing EP-104GI as a treatment for eosinophilic esophagitis (EoE). At the nine‐month mark, patients who received a 48mg dose showed sustained or even improved treatment outcomes, with the drug continuing to release steadily into the esophagus – a first for an injectable system in EoE. Clinical measures indicated reduced symptoms, improved tissue health, and lower eosinophil counts, suggesting that EP-104GI may help remodel esophageal tissue over time.
The encouraging durability of these benefits highlights EP-104GI’s potential to significantly improve care for patients with EoE. Further long-term data with higher doses is expected in the future, and a webinar featuring clinical insights is scheduled to discuss these findings in more detail.
Read Announcement- Drug:
- EP-104GI
- Announced Date:
- February 25, 2025
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc. announced additional positive clinical data from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").
AI Summary
Eupraxia Pharmaceuticals Inc. announced new clinical data from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI as a treatment for eosinophilic esophagitis (EoE). The study shows that as the dose and coverage area of EP-104GI increases in the esophagus, both symptom scores and histological improvements continue to improve. In particular, the sixth cohort, which received a higher dose across a wider esophageal area, displayed the greatest relief in symptoms and tissue health improvements, along with a significant reduction in peak eosinophil counts. These results indicate a clear dose-response benefit, suggesting that precise, localized delivery of EP-104GI may lead to better outcomes for patients with EoE.
Additionally, the treatment has shown a strong safety profile, with no serious adverse events or cases of oral or gastrointestinal candidiasis reported in the trial cohorts to date. These encouraging outcomes highlight EP-104GI's potential as a new standard of care for EoE.
Read Announcement- Drug:
- EP-104GI
- Announced Date:
- October 10, 2024
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc. announced that the Company will be presenting a poster at the upcoming United European Gastroenterology ("UEG") Week 2024 to be held in Vienna, Austria, on October 12-15, 2024.
AI Summary
Eupraxia Pharmaceuticals Inc. announced that it will present a poster at United European Gastroenterology (UEG) Week 2024 in Vienna, Austria, from October 12‑15, 2024. The company will feature its latest research as part of one of the foremost global conferences for gastroenterology. The poster, numbered PP0584, is titled “Results from Dose Escalation in RESOLVE, an Ongoing Phase 1b/2a Dose-Escalation Study of EP‑104GI (Extended‑Release Fluticasone Propionate Intra‑Esophageal Injection) for Eosinophilic Esophagitis” and will include data from cohorts one through four of the ongoing RESOLVE trial.
This presentation provides an opportunity for Eupraxia to share groundbreaking clinical trial results and highlight its innovative approach to targeted, extended‑release therapies for gastrointestinal conditions. The data will also be accessible through the company’s website, engaging both onsite and online audiences at the hybrid event.
Read Announcement- Drug:
- EP-104GI
- Announced Date:
- September 11, 2024
- Indication:
- For Treatment of Eosinophilic Esophagitis
Announcement
Eupraxia Pharmaceuticals Inc. announced additional positive clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis ("EoE").
AI Summary
Eupraxia Pharmaceuticals Inc. announced encouraging new clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating EP-104GI as a treatment for eosinophilic esophagitis (EoE). In the fourth cohort, patients received a series of 12 injections using the company’s DiffuSphere™ technology, with positive results observed in key metrics. Most patients showed improved outcomes, as seen in reduced dysphagia symptoms—with reductions in the Straumann Dysphagia Index of up to 67% from baseline—and significant improvements in the histology scoring system, with a 39% reduction in composite scores.
The data indicate that EP-104GI delivers comparable improvements to those of current therapies, while maintaining a favorable safety profile with no reported serious adverse events. The trial continues to evaluate the optimal dosing levels and may offer new insights into effective treatment for this challenging esophageal condition.
Read Announcement
Eupraxia Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Eupraxia Pharmaceuticals (EPRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Eupraxia Pharmaceuticals (EPRX) has reported FDA regulatory activity for EP-104GI.
The most recent FDA-related event for Eupraxia Pharmaceuticals occurred on September 29, 2025, involving EP-104GI. The update was categorized as "Provided Update," with the company reporting: "Eupraxia Pharmaceuticals Inc today provided an operational update on the development of EP-104GI, including reporting data from patients in Cohort 9 of the dose escalation portion of the RESOLVE trial, the first time that patients received an 8mg dose per injection."
Currently, Eupraxia Pharmaceuticals has one therapy (EP-104GI) targeting the following condition: For Treatment of Eosinophilic Esophagitis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:EPRX) was last updated on 10/1/2025 by MarketBeat.com Staff
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