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A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

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Trial Profile

A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2026

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At a glance

  • Drugs Hypericin sodium (Primary)
  • Indications Cutaneous T-cell lymphoma
  • Focus Therapeutic Use
  • Acronyms FLASH2
  • Sponsors Soligenix

Most Recent Events

  • 08 May 2026 According to Soligenix media release, If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte™ therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
  • 28 Apr 2026 Status changed from recruiting to discontinued, according to Soligenix media release.
  • 28 Apr 2026 According to Soligenix media release, company intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)."

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