We Are Focused on the Rapid Clinical and Commercial Development of New Medicines Based on Our Exceptional 3D Human Tissue Model Technology.
Organovo Has FDA Approval for FXR314 for Phase 2 Clinical Trial in Ulcerative Colitis
Organovo has an FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis for its lead therapeutic molecule FXR314. We have advanced our proprietary 3D human tissue models to support the most effective clinical development strategy for FXR314 and the treatment of inflammatory bowel diseases including Crohn’s Disease. FXR314 also has potential applications in the treatment of metabolic disease and oncology.
FXR314, has shown, in initial clinical trials, to be a possible best-in-class FXR agonist that is delivered orally, with high potency, safety, tolerability and the potential to avoid dose-limiting toxicity issues found in other FXR targeted compounds. FXR314 has received FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis. Organovo is also advancing FXR314 for the treatment of other Inflammatory Bowel Diseases including Crohn’s Disease as well as diseases of the Liver including NASH and Primary Biliary Cholangitis. Organovo expects FXR314 to have a widening set of therapeutic applications as we advance our knowledge and our science.
In addition to FXR314, Organovo is planning to begin medicinal chemistry in 2023 to create a novel drug for another, as yet undisclosed, target. The target was validated in our 3d tissue models of Crohn’s disease. We expect the drug created to have an IND by the end of 2025.
| Program | Indication | Discovery | Phase 1 | Phase 2/3 | Areas of Clinical Focus |
|---|---|---|---|---|---|
| FXR314 | Inflammatory Bowel Disease | Ulcerative Colitis | |||
| Novel Drug to Undisclosed Target | Inflammatory Bowel Disease | IND Expected 2025 |
Crohn’s Disease | ||
| FXR314 | Liver Fibrosis | Phase 2 Ready. Seeking Development Partner |
NASH & Primary Biliary Cholangitis | ||
| Discovery | Phase 1 | Phase 2/3 |
| FXR314 — Inflammatory Bowel Disease | ||
| Areas of Clinical Focus: Ulcerative Colitis | ||
| Novel Drug to Undisclosed Target — Inflammatory Bowel Disease IND Expected 2025 | ||
| Areas of Clinical Focus: Crohn’s Disease | ||
| FXR314 — Liver Fibrosis Phase 2 Ready. Seeking Development Partner | ||
| Areas of Clinical Focus: NASH & Primary Biliary Cholangitis | ||
