Drugs / RBT-1
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03893799 | Aug 2019 → Apr 2020 | chronic kidney disease | Renibus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT06021457 | Oct 2023 → Jun 2025 | — | Renibus Therapeutics, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | Renibus Therapeutics, Inc. | Results Renibus Therapeutics Announces Oral Presentation on Phase 3 PROTECT Trial Data for RBT-1 at the American Association for Thoracic Surgery (AATS) Annual Meeting renibus.com ↗
The PROTECT study did not meet its primary endpoint, a hierarchical composite (win ratio) of death, dialysis-requiring AKI, 30-day cardiopulmonary readmission, and ICU days (WR 0.87 [0.66, 1.15], p=0.33), and key secondary endpoints were also not statistically significant. |
| 2024-10-03 | Renibus Therapeutics, Inc. | Results Renibus Therapeutics Presents Two Posters on RBT-1 , a First-in-Class Preconditioning Agent, at the Academy of Managed Care Pharmacy (AMCP) Nexus 2024 Meeting renibus.com ↗
From the completed Phase 2 clinical trial, RBT-1 demonstrated the potential to reduce post-operative complications for patients and significantly lower healthcare costs in cardiac surgery patients, including those undergoing CABG and valve procedures. |
| 2024-01-09 | Renibus Therapeutics, Inc. | Results Renibus Announces Publication of Results from Phase 2 Study Evaluating RBT-1 as a Pre-Conditioning Agent to Reduce Post-Operative Complications Following Cardiothoracic Surgery renibus.com ↗
Renibus Announces Publication of Results from Phase 2 Study Evaluating RBT-1 as a Pre-Conditioning Agent to Reduce Post-Operative Complications Following Cardiothoracic Surgery |
| 2023-09-11 | Renibus Therapeutics, Inc. | Results Renibus Presents Phase 2 Results on RBT-1, a First-in-Class Preconditioning Agent, at the American Society for Enhanced Recovery and Perioperative Medicine (ASER PM) 2023 Meeting renibus.com ↗
The data presented at ASER PM 2023 demonstrated that RBT-1 increased cytoprotective protein levels and improved clinical outcomes in a recently completed Phase 2 study. |
| 2023-07-11 | Renibus Therapeutics, Inc. | Regulatory Renibus Therapeutics Announces Breakthrough Therapy Designation from US FDA for RBT-1 for the Reduction in Risk of Post-Operative Complications in Patients Undergoing Cardiothoracic Surgery renibus.com ↗ |
| 2023-05-05 | Renibus Therapeutics, Inc. | Results Renibus Reports Positive Final Results from Phase 2 Study of RBT-1, a First-in-Class Preconditioning Agent for Patients Undergoing Cardiothoracic Surgery, at the American Association for Thoracic Surgery (AATS) Meeting renibus.com ↗
RBT-1 treated patients demonstrated a highly significant increase in anti-inflammatory and antioxidant biomarkers of cytoprotective preconditioning, which was the primary endpoint of the study. |
| 2023-01-19 | Renibus Therapeutics, Inc. | Results Renibus Therapeutics Announces Oral Presentation on RBT-1 Phase 2 Results at 2023 Society of Critical Care Medicine (SCCM) Meeting renibus.com ↗
RBT-1 met the primary biomarker endpoint as well as several key clinical endpoints; positive data supports the potential for RBT-1 to improve postoperative outcomes in cardiothoracic surgery |
| 2023-01-05 | Renibus Therapeutics, Inc. | Results Renibus Therapeutics Announces Positive 30-Day Topline Data from RBT-1 Phase 2 Trial renibus.com ↗
Renibus Therapeutics® (“Renibus”), a clinical-stage biotech company focusing on the prevention and treatment of cardio-renal diseases, today announced positive 30-day topline data from RBT-1 in a Phase 2 trial. |
| 2022-11-07 | Renibus Therapeutics, Inc. | Results Renibus Therapeutics Presents Interim Phase 2 Data: RBT-1 Improves Post-Operative Outcomes in Cardiac Surgery Patients During Oral Session at AHA Scientific Sessions 2022 renibus.com ↗
RBT-1 interim results from a randomized double-blind placebo-controlled study showed statistically significant reductions in days on ventilator and days in ICU. |
| 2020-06-09 | Renibus Therapeutics, Inc. | Results Renibus Therapeutics® Announces Abstract Presentation at the 2020 European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Annual Congress renibus.com ↗
These same cytoprotective proteins were also increased in healthy volunteers and patients with Stage 3/4 CKD enrolled in a Phase 1 study of RBT-1 (NCT03893799). |
All press releases naming this drug 17 releases
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 | RBT-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06021457 ↗ |
| Route | Intravenous | “Single intravenous administration” NCT03893799 ↗ |