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?

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

Next Previous
Search
Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Dec 2024

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 Sotagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms inTandem3
  • Sponsors Lexicon Pharmaceuticals

    • Most Recent Events

    • 20 Dec 2024 According to a Lexicon Pharmaceuticals media release, company announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
    • 31 Oct 2024 According to a Lexicon Pharmaceuticals media release, the company announced the outcome of the USFDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the companys New Drug Application (NDA) for Zynquista (sotagliflozin), as an adjunct to insulin therapy for glycemic control in adults with T1D and CKD. The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks in adults with T1D and CKD.
    • 01 Aug 2024 According to a Lexicon Pharmaceuticals media release, company has resubmitted its NDA for ZYNQUISTA as an adjunct to insulin in adults with type 1 diabetes and CKD on June 20, 2024. FDA notified the company that it considers the resubmission to be a complete response to its 2019 action letter regarding the NDA and provided a PDUFA goal date of December 20, 2024. Preparations are underway for an early 2025 launch.

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

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
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