Drugs / REACT
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05694169 | Jul 2023 → Mar 2024 | congenital anomaly of kidney and urinary tract, diabetic kidney disease | Prokidney | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-11-06 | Prokidney | Results ProKidney Presents Full Results from the Phase 2 REGEN-007 Trial of Rilparencel at the American Society of Nephrology Kidney Week 2025 prokidney.com ↗ |
| 2025-07-15 | Prokidney | Regulatory ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel prokidney.com ↗
FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetes |
| 2025-07-08 | Prokidney | Results ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes prokidney.com ↗
In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). |
| 2023-11-13 | Prokidney | Results ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates prokidney.com ↗
Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients |
| 2023-01-10 | Prokidney | Results ProKidney Announces Publication of Trial Design for Phase 2 Multicenter Clinical Trial of REACT for Late Stage 4 Diabetes-Related Chronic Kidney Disease prokidney.com ↗ |
| 2022-11-03 | Prokidney | Regulatory ProKidney Receives Allowance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for proact 1 (REGEN-006) and EMA Scientific Advice on Phase 3 Protocols of REACT for Diabetic Chronic Kidney Disease prokidney.com ↗
In a related regulatory development, ProKidney also received favorable scientific advice from the European Medicines Agency (EMA) on the adequacy of its Phase 3 development program, consisting of proact 1 and proact 2, to support an eventual marketing authorization application (MAA). |
| 2022-06-23 | Prokidney | Results ProKidney Corroborates the Mechanism of Action of REACT™ with Cell Marker Analysis in Patients with Diabetic Chronic Kidney Disease prokidney.com ↗
The paper, published in Kidney International Reports, describes observed improvements in renal function and a wide array of clinical parameters in patients with moderate to advanced diabetic CKD treated with REACT™. |
| 2022-05-03 | Prokidney | Regulatory ProKidney highlights key registrational program elements supporting advancement of REACT® prokidney.com ↗
Furthermore, the FDA accepted ProKidney’s proposal for a long-term 5-year clinical follow-up program for all REACT® injected patients, to be enrolled with patients who have previously received REACT® injections in one or both kidneys. |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | REACT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05694169 ↗ |
| Modality | Cell therapy | “Autologous selected renal cells (SRC)” NCT05694169 ↗ |