Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LMB763
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 ...
Top 3 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Rilparencel |
Nidufexor is an investigational small molecule developed by Novartis AG for diabetic nephropathy, a kidney complication of diabetes. It is a Phase 2 drug candidate and has not been approved for any indication. It was studied in a single completed Phase 2 clinical trial.
Nidufexor was studied as a treatment for diabetic nephropathy, a kidney condition that occurs in people with diabetes. It was evaluated in a Phase 2 trial in adults with the condition. It remains investigational and is not approved for treating diabetic nephropathy or any other indication.
Nidufexor targets NR1H4, also known as the farnesoid X receptor, and acts as an agonist at this receptor. NR1H4 is a nuclear receptor involved in metabolic and bile acid signaling. Nidufexor is a small molecule agonist designed to activate this target.
Nidufexor is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the Phase 2 clinical trial of nidufexor in diabetic nephropathy. The drug remains an investigational asset in the company's pipeline.
Nidufexor is in Phase 2 development. Its only clinical trial, a completed Phase 2 study in diabetic nephropathy, has finished and no trials are currently active. Nidufexor is investigational and has not received FDA approval for any indication.
Nidufexor was evaluated in one Phase 2 trial, NCT03804879, titled Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy. The completed trial enrolled 83 adults across the United States, Argentina, Czechia, Germany, Jordan, Lebanon, and Turkey, and was randomized, double-blind, and placebo-controlled.