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RE-021 · 1 trial · 1 indication
Primary efficacy objective is to determine the change in UP/C in FSGS patients receiving RE-021 (Sparsentan) from baseline to 8 weeks over a range of dose levels compared to treatment with irbesartan as active control.
| Arm | Type | Description |
|---|---|---|
| RE-021 (Sparsentan) 200 mg - Double-Blind Period | EXPERIMENTAL | RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration. |
| RE-021 (Sparsentan) 400 mg - Double-Blind Period | EXPERIMENTAL | RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration. |
| RE-021 (Sparsentan) 800 mg - Double-Blind Period | EXPERIMENTAL | RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration. |
| Irbesartan 300 mg - Double-Blind Period | ACTIVE_COMPARATOR | The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks. Patients at \</= 50kg will receive 150mg irbesartan for the 8 week duration. |
| RE-021 (Sparsentan) - Open-Label Extension Period | EXPERIMENTAL | Includes all subjects who completed the Double-Blind period and enrolled in the Open-Label Extension period of the study. All subjects who completed the Double-Blind period were evaluated for response and safety at the Week 8 visit to determine eligibility for continued treatment on their assigned doses in an Open-Label Extension period for up to 496 additional weeks. Subjects treated with irbesartan during the Double-Blind period were offered sparsentan treatment at the dose they would have received according to the Double-Blind dose cohort in which they were enrolled. |
| Name | Type | Description |
|---|---|---|
| RE-021 (Sparsentan) | DRUG | Oral, once-daily |
| Irbesartan | DRUG | Oral, once-daily |
Inclusion Criteria 1. Biopsy-proven FSGS OR documentation of a genetic mutation in a podocyte protein associated with the disease. 2. Urine protein/creatinine ratio (Up/C) at or above 1.0 g/g. 3. Estimated glomerular filtration rate (eGFR) \>30. 4. Mean seated blood pressure (BP) \>100/60 mmHg and ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | frexalimab, brivekimig, rilzabrutinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Praliciguat |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| Vera Therapeutics, Inc. Class A | VERA | 1 | PHASE2 | Atacicept |
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.'