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A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty

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Trial Profile

A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Bupivacaine (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Pharmacokinetics; Registrational
  • Acronyms SPARK
  • Sponsors Allay Therapeutics

Most Recent Events

  • 05 Jun 2025 According to Allay Therapeutics Media Release, company announced the completion of a 57.5M Series D financing round with leading global investors.Proceeds from the financing supports the Companys Phase 2b registration trial evaluating ATX101 for the treatment of post-surgical pain following total knee replacement (TKA).
  • 04 Dec 2024 According to Allay Therapeutics Media Release, company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for its lead investigational product ATX101 for treatment of postsurgical pain following TKA procedures in adults. This Breakthrough Therapy designation was granted based on clinical data from a Phase 2 exploratory dose-ranging trial for the treatment of Post-Surgical Pain following Total Knee Arthroplasty (TKA), or replacement.
  • 26 Jun 2024 Status changed from active, no longer recruiting to discontinued.

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