Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
R2R01 · 1 trial · 1 indication
The outcome will be measured as: • Nature, of treatment-emergent adverse events (TEAEs).
The outcome will be measured as frequency of treatment-emergent adverse events (TEAEs).
| Arm | Type | Description |
|---|---|---|
| R2R01 at a dose of 5.0 mg | EXPERIMENTAL | Drug |
| R2R01 at a dose of 2.5 mg | EXPERIMENTAL | Drug |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| R2R01 | DRUG | R2R01 (i.e., 5.0 mg and 2.5 mg, or alternative doses, as recommended by the SRC) |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF). * At least 18 years of age. * Subject is scheduled for non-emergent CABG (sing...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
R2R01 is an investigational small molecule being developed for Acute Kidney Injury (AKI). It is currently being studied in patients at high risk for cardiac surgery-associated acute kidney injury, a serious complication that can occur after heart surgery. The drug is in Phase 2 clinical development and has not been approved by regulatory authorities.
R2R01 is a relaxin agonist, meaning it activates relaxin receptors in the body. Relaxin is a hormone that can promote vasodilation and improve blood flow, which may help protect the kidneys from injury. By targeting these receptors, R2R01 aims to reduce the risk of acute kidney injury in high-risk patients undergoing cardiac surgery.
R2R01 is being developed by Baxter International Inc., a global medical products company traded on the New York Stock Exchange under the ticker symbol BAX. Baxter is conducting clinical trials to evaluate the safety and efficacy of R2R01 for the prevention of acute kidney injury in patients undergoing cardiac surgery.
R2R01 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is recruiting participants to assess the drug's effectiveness and safety in preventing acute kidney injury following cardiac surgery.
R2R01 is being studied in a Phase 2 clinical trial registered as NCT07625553. This randomized, double-blind, placebo-controlled trial is recruiting 430 adults in Italy who are at high risk for cardiac surgery-associated acute kidney injury. The study is currently active and enrolling participants, with no completed trials for R2R01 to date.
R2R01 is a relaxin agonist, not the same as the natural hormone relaxin. While relaxin is a peptide hormone, R2R01 is a small molecule designed to activate the same receptors. This synthetic approach may offer advantages in stability and delivery compared to the natural hormone, though both target the relaxin pathway.