Drugs / RLS-0071
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05351671 | May → Sep 2022 | — | ReAlta Life Sciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05298787 | Jan → Aug 2021 | — | ReAlta Life Sciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04574869 | Jan 2021 → Sep 2022 | COVID-19, acute lung injury | ReAlta Life Sciences, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 23 trials | ||||||
| Phase 2 | NCT06343792 | Aug 2024 → Dec 2026 expected | — | ReAlta Life Sciences, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06175065 | Jan 2024 → Jun 2025 overdue | chronic obstructive pulmonary disease | ReAlta Life Sciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05778188 | Jul 2023 → Dec 2026 expected | brain hypoxia - ischemia | ReAlta Life Sciences, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-07-22 | ReAlta Life Sciences, Inc. | Results ReAlta Life Sciences Publishes Data Demonstrating RLS-0071 (pegtarazimod) Reduces Brain Inflammation in Preclinical Hypoxic Ischemic Encephalopathy Model realtalifesciences.com ↗ |
| 2025-04-25 | ReAlta Life Sciences, Inc. | Results ReAlta Life Sciences Announces New Clinical Data for RLS-0071 (pegtarazimod) from Hypoxic Ischemic Encephalopathy Program at Pediatric Academic Societies 2025 Meeting realtalifesciences.com ↗
Biomarker data from the ongoing Phase 2 STAR trial provide the first confirmatory evidence in humans of inflammatory mechanisms previously observed only in animal models of HIE. |
| 2022-04-04 | ReAlta Life Sciences, Inc. | Results ReAlta Life Sciences’ RLS-0071 Demonstrates Excellent Safety Profile and Confirmed Target Engagement in First-in-Human Phase 1 Clinical Trial realtalifesciences.com ↗
RLS-0071 demonstrated an excellent safety profile and confirmed target engagement in healthy volunteers. |
| 2022-03-30 | ReAlta Life Sciences, Inc. | Regulatory FDA Clears ReAlta Life Sciences' Phase 2 STAR Trial of RLS-0071 in Neonates with Hypoxic-Ischemic Encephalopathy realtalifesciences.com ↗
ReAlta Life Sciences (“ReAlta”), Inc., a clinical stage, rare disease company dedicated to harnessing the power of the immune system to address life threatening diseases, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 2 clinical trial of RLS-0071 in neonates with hypoxic-ischemic encephalopathy (HIE). |
| 2020-12-03 | ReAlta Life Sciences, Inc. | Regulatory ReAlta Life Sciences Announces EMA Orphan Drug Designation for RLS-0071 For The Treatment Of Neonatal Encephalopathy realtalifesciences.com ↗ |
| 2020-02-06 | ReAlta Life Sciences, Inc. | Regulatory ReAlta Life Sciences Announces FDA Orphan Drug Designation for PIC1 for the Treatment of Hypoxic-Ischemic Encephalopathy realtalifesciences.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RLS-0071 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06343792 ↗ |
| Action | Inhibit | “specifically inhibits multiple inflammatory pathways” NCT05351671 ↗ |
| Modality | Peptide | “RLS-0071 is a novel peptide” NCT05778188 ↗ |
| Route | Intravenous | “RLS-0071 is administered as an IV infusion” NCT05298787 ↗ |