Drugs / RXC007
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | idiopathic pulmonary fibrosis | — | “Partial Clinical Hold (PCH) placed on the zelasudil (RXC007) Phase 2a trial in Idiopathic Pulmonary Fibrosis (IPF)” redxpharma.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04931147 | May 2021 → Mar 2023 | idiopathic pulmonary fibrosis, kidney disorder, metabolic dysfunction-associated steatohepatitis | Redx Pharma Ltd | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05570058 | Sep 2022 → Jun 2024 overdue | idiopathic pulmonary fibrosis, pulmonary fibrosis | Redx Pharma Ltd | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-01-07 | Redx Pharma Ltd | Regulatory US FDA lifts Partial Clinical Hold on Zelasudil redxpharma.com ↗
We are thrilled with the decision of the FDA to lift the partial clinical hold placed on zelasudil following the review of our clinical data package. |
| 2025-09-29 | Redx Pharma Ltd | Results Redx presents encouraging signal searching data for zelasudil (RXC007) as a well-tolerated treatment for Idiopathic Pulmonary Fibrosis at ERS redxpharma.com ↗
Redx Pharma, the clinical-stage, biotechnology company focused on developing novel, small molecule, targeted therapeutics for fibrotic disease, today announces the presentation of new data from the zelasudil Phase 2a signal searching study in idiopathic pulmonary fibrosis (IPF) at the European Respiratory Society (ERS) meeting in Amsterdam. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-07 | Redx Pharma Ltd | US FDA lifts Partial Clinical Hold on Zelasudil redxpharma.com ↗ |
| 2025-09-29 | Redx Pharma Ltd | Redx presents encouraging signal searching data for zelasudil (RXC007) as a well-tolerated treatment for Idiopathic Pulmonary Fibrosis at ERS redxpharma.com ↗ |
| 2025-09-22 | Redx Pharma Ltd | Redx Pharma to present new Phase 2a data for zelasudil (RXC007) at ERS redxpharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RXC007 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05570058 ↗ |
| Route | Oral | “RXC007 will be administered in the form of oral capsules” NCT04931147 ↗ |