Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RE-021, sparsentan · 1 trial · 1 indication
Evaluation of, at minimum, the maximum concentration (Cmax) parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Evaluation of, at minimum, the area under the concentration-time curve from dosing time 0 (AUC(0-last)) parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Evaluation of, at minimum, the area under the concentration curve to infinite (AUC(0-inf)) time parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Evaluation of the ratio, fed/fasted, for the Cmax
Evaluation of the ratio, fed/fasted, for the AUC(0-last)
Evaluation of the ratio, fed/fasted, for the AUC(0-inf)
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: Cmax from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: Area under the plasma concentration-time curve over the last 24-h dosing interval (AUC(0-24)) from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: temporal change parameter (TCP) (AUC(0-24)/AUC(0-inf)) from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
| Arm | Type | Description |
|---|---|---|
| Fasted State | EXPERIMENTAL | Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will be randomized to 1 of 3 dose levels (200mg, 400mg and 800 mg) and will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study Day 1) |
| Fed State | EXPERIMENTAL | Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will have a single dose of sparsentan (200mg, 400mg and 800 mg) in the fed state (high-fat breakfast) on Period 2, Day 1 (Study Day 8) |
| Fed State - Multiple | EXPERIMENTAL | Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will have multiple doses of sparsentan (200mg, 400mg and 800 mg) in the fed state on Period 3, Days 1 to 14 (Study days 12 to 25) |
| Name | Type | Description |
|---|---|---|
| RE-021, sparsentan | DRUG | RE-021, sparsentan - Subjects will be randomized 1 of 3 dose level |
Inclusion Criteria: 1. Healthy males or healthy females of non-childbearing potential 2. Between 18 and 55 years of age, inclusive, at time of signing informed consent 3. Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening 4. Must be willing and able to communicate and participate ...
RE-021, also known as sparsentan, is an investigational small molecule being studied for the treatment of focal segmental glomerulosclerosis (FSGS), a kidney disorder. It has also been evaluated in healthy subjects for pharmacokinetic purposes. The drug is in clinical development by Travere Therapeutics, Inc. (NASDAQ: TVTX).
RE-021 (sparsentan) is a small molecule that targets the endothelin and angiotensin pathways. It acts as a dual endothelin receptor antagonist and angiotensin II receptor blocker, which may help reduce proteinuria and slow kidney damage in conditions like focal segmental glomerulosclerosis.
RE-021 is being developed by Travere Therapeutics, Inc., a biopharmaceutical company listed on NASDAQ under the ticker TVTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in focal segmental glomerulosclerosis and its pharmacokinetics in healthy subjects.
RE-021 has completed a Phase 2 clinical trial in focal segmental glomerulosclerosis and a Phase 1 trial in healthy subjects. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial was randomized, double-blind, and active-controlled, enrolling 109 participants.
RE-021 has been studied in two completed trials. NCT01613118 was a Phase 2 randomized, double-blind, safety and efficacy study in focal segmental glomerulosclerosis, enrolling 109 participants in the United States, Czechia, and Italy. NCT05562362 was a Phase 1 study evaluating the pharmacokinetics of oral sparsentan suspension in 47 healthy subjects in the United Kingdom.
Yes, RE-021 is also known as sparsentan. Clinical trials for the drug use the name sparsentan in their titles, such as NCT01613118, which is titled 'Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis.'