Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nefecon · 1 trial · 1 indication
Part A primary endpoint: The ratio of Urine Protein to Creatinine Ratio (UPCR) (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline. Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram
Part B Primary endpoint: Time-weighted average of estimated glomerular filtration rate (eGFR) recordings observed at each time point over 2 years. The eGFR (CKD-EPI) at 2 years (which must have been repeated to provide a second value obtained within 14 to 35 days) was the geometric mean of the 2 assessments.
| Arm | Type | Description |
|---|---|---|
| Nefecon | EXPERIMENTAL | Nefecon 16 mg once daily by mouth for 9 months. |
| Placebo oral capsule | PLACEBO_COMPARATOR | Placebo oral capsule once daily by mouth for 9 months. |
| Name | Type | Description |
|---|---|---|
| Nefecon | DRUG | Nefecon 16 mg for daily administration by mouth for 9 months. |
| Placebo oral capsule | DRUG | Placebo capsules for daily administration by mouth for 9 months. |
Inclusion Criteria: 1. Female or male patients ≥18 years 2. Biopsy-verified IgA nephropathy 3. Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines 4. U...
Nefecon is an investigational small molecule being studied for the treatment of Primary IgA Nephropathy, a kidney disease. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy and safety in patients with this condition.
Nefecon is a small molecule being developed for Primary IgA Nephropathy. The specific molecular target of Nefecon has not been disclosed in the available information. The drug is being studied for its effects on this kidney condition, but its precise mechanism of action is not publicly detailed.
Nefecon is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research on this drug for the treatment of Primary IgA Nephropathy. cbdMD, Inc. is responsible for the development and potential commercialization of Nefecon.
Nefecon is currently in Phase 3 clinical development for Primary IgA Nephropathy. This is the final stage of clinical trials before potential regulatory submission. The drug is still investigational and has not been approved by the FDA or other regulatory agencies. A Phase 3 trial has been completed to evaluate its safety and efficacy.
Nefecon has one completed Phase 3 clinical trial registered under NCT03643965, titled "Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy." This randomized, double-blind, placebo-controlled trial enrolled 365 participants across multiple countries including the United States, Argentina, Australia, and several European and Asian nations.
Nefecon is not known to have any alternative names or be the same as other drugs. It is a distinct investigational small molecule being developed by cbdMD, Inc. for Primary IgA Nephropathy. No other names or aliases for this drug have been identified in the available information.