Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IW-1973 · 2 trials · 2 indications
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those adverse events (AEs) that started or worsened in severity after the administration of study drug. Causality relationship to study drug was per Investigator assessment. Number of participants with TEAEs and study drug-related TEAEs is presented.
Peak VO2 was obtained from Cardiopulmonary Exercise Test (CPET), which was used to evaluate the effect of praliciguat on peak exercise capacity. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an analysis of covariance (ANCOVA) model with treatment group and atrial fibrillation stratification factors as categorical variable terms and Baseline peak VO2 value as a covariate. Milliliter O2 per kilogram per minute = mL O2/kg/min
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. Causality relationship to study drug was per Investigator assessment.
Urine samples were collected for the analysis of UACR. UACR (milligrams per gram \[mg/g\]) was calculated as urine albumin (mg per deciliter \[mg/dL\]) / urine creatinine (g/dL). Change from Baseline was calculated as the average of the UCAR values at Weeks 8 and 12 minus the Baseline value. Data were analyzed using a mixed-effects model repeated measures (MMRM) analysis with change from Baseline in log-transformed UACR as the response variable, treatment, visit, treatment-by visit interaction, and Baseline estimated glomerular filtration rate stratum as fixed effects, Baseline log-transformed UACR and Baseline mean arterial pressure as covariates, and unstructured as the variance-covariance structure.
| Arm | Type | Description |
|---|---|---|
| IW-1973 High Dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Placebo to match experimental drug |
| IW-1973 Low Dose | EXPERIMENTAL | Administered daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| IW-1973 | DRUG | Oral Tablet |
| Placebo Oral Tablet | DRUG | Oral Tablet |
| Placebo | DRUG | Oral Tablet |
Inclusion Criteria: 1. Patient is an ambulatory male or female ≥45 years old at the Screening Visit 2. Patient has heart failure with ejection fraction (EF) of ≥40% 3. Patient has a peak VO2 measuring \<80% of age- and sex-adjusted normal values 4. Patient has evidence in medical history supporting...
IW-1973 is an investigational small molecule being studied for Type 2 Diabetes Mellitus with Diabetic Nephropathy and Heart Failure with Preserved Ejection Fraction (HFpEF). It has completed Phase 2 clinical trials for both indications, but it is not approved and remains in clinical development.
IW-1973 is a soluble guanylate cyclase (sGC) stimulator. It works by stimulating sGC, an enzyme involved in the nitric oxide signaling pathway, which plays a role in vascular function. This mechanism is being studied for its potential effects in diabetic nephropathy and heart failure with preserved ejection fraction.
IW-1973 is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company is conducting clinical research on this investigational drug for cardiovascular and kidney-related conditions.
IW-1973 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in diabetic nephropathy and one in heart failure with preserved ejection fraction. The drug is investigational and has not received FDA approval.
IW-1973 has completed two Phase 2 trials. NCT03217591 evaluated the drug in 156 patients with Type 2 Diabetes Mellitus and Diabetic Nephropathy in the United States. NCT03254485 studied its effect on exercise capacity in 196 patients with Heart Failure with Preserved Ejection Fraction in the United States and Canada.
IW-1973 is also known as praliciguat. The drug is referred to by both names in clinical research, and it is being developed by Akebia Therapeutics. It is an investigational soluble guanylate cyclase stimulator studied for diabetic nephropathy and heart failure with preserved ejection fraction.