Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLBS201 · 1 trial · 1 indication
Proportion of patients with a treatment-emergent serious adverse event
| Arm | Type | Description |
|---|---|---|
| CLBS201 | EXPERIMENTAL | CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation. |
| Name | Type | Description |
|---|---|---|
| CLBS201 | DRUG | 1 x 10\^6 to 300 x 10\^6 autologous CD34+ cells |
Inclusion Criteria: 1. Adults aged 18 to 75 years, inclusive 2. Documented diagnosis of type 2 diabetes 3. eGFR of 30 to \<45 mL/min/1.73m at the screening visit. 4. UACR 300 mg/g to ≤ 5000 mg/g Exclusion Criteria: 1. Hemoglobin \< 10 g/dL 2. Hemoglobin A1c ≥8% at the time of screening 3. Acute k...
CLBS201 is an investigational small molecule being developed for chronic kidney disease. It was studied in patients with chronic kidney disease and type 2 diabetes mellitus. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
CLBS201 is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LSTA. The company is conducting clinical research on this investigational drug for chronic kidney disease.
CLBS201 is in Phase 1 clinical development. A Phase 1 clinical trial of CLBS201 in patients with chronic kidney disease and type 2 diabetes mellitus has been completed. The drug remains investigational and has not received FDA approval.
CLBS201 has one completed Phase 1 clinical trial, registered as NCT04990427, which studied the drug in patients with chronic kidney disease and type 2 diabetes mellitus. The trial enrolled 6 participants in the United States and has been completed.
No, CLBS201 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial of CLBS201 for chronic kidney disease has been completed, but the drug has not yet received regulatory approval.