Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nidufexor · 1 trial · 1 indication
UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin \[mg/L\] / urine creatinine \[mmol/L\]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table.
| Arm | Type | Description |
|---|---|---|
| LMB763 | EXPERIMENTAL | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. |
| Placebo | PLACEBO_COMPARATOR | Placebo was orally administered once daily for 24 weeks in addition to SoC. |
| Name | Type | Description |
|---|---|---|
| Nidufexor | DRUG | 50 mg (two 25 mg) LMB763 capsules for oral administration |
| Placebo | OTHER | Placebo capsules for oral administration |
| Standard of Care (SoC) | DRUG | Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) |
Inclusion Criteria: * Male/female patients, 18-75 years * Written informed consent * Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening * Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| DexCom, Inc. | DXCM | 1 | PHASE3 | Sotagliflozin |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Renal Autologous Cell Therapy |
Nidufexor is an investigational small molecule being studied for the treatment of diabetic nephropathy, a kidney condition that can occur in people with diabetes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Nidufexor is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for diabetic nephropathy.
Nidufexor is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved for any use.
Nidufexor has one completed Phase 2 clinical trial registered as NCT03804879, titled 'Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy.' The trial enrolled 83 participants across the United States, Argentina, Czechia, Germany, Jordan, Lebanon, and Turkey.
Nidufexor is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for diabetic nephropathy. The completed Phase 2 trial was a randomized, double-blind, placebo-controlled study with 83 participants.