Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

Next Previous
Trial Profile

Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Oct 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Sparsentan (Primary) ; Irbesartan
  • Indications Focal segmental glomerulosclerosis
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms DUET
  • Sponsors Travere Therapeutics

Most Recent Events

  • 27 Aug 2025 According to a Travere Therapeutics media release, a supplemental New Drug Application (sNDA) for FILSPARI in FSGS is currently under review with the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.
  • 27 Aug 2025 According to a Travere Therapeutics media release, the reduction of FILSPARI liver monitoring REMS from monthly to every three months from the onset of treatment was supported by safety data from this trial.
  • 15 May 2025 According to Travere Therapeutics Inc media release, based on results from DUPLEX Study and the DUET Study,the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026, is currently planning to hold an advisory committee meeting to discuss the application.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top