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A Pivotal, Randomized, Double-blind, Vehicle-controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

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Trial Profile

A Pivotal, Randomized, Double-blind, Vehicle-controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2024

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At a glance

  • Drugs Paromomycin (Primary) ; Gentamicin
  • Indications Cutaneous leishmaniasis
  • Focus Therapeutic Use

Most Recent Events

  • 31 Oct 2024 According to an Appili Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has provided positive feedback regarding the development strategy for ATI-1801, and agreed on the necessary registration package to support a New Drug Application
  • 13 Feb 2024 According to an Appili Therapeutics media release, In January 2024, Appili requested a meeting with the FDA to discuss the previously generated Phase 3 data and agree on the necessary registration package to support a New Drug Application submission
  • 13 Nov 2023 According to an Appili Therapeutics media release, company plans to meet with the FDA later this year to discuss the previously generated Phase 3 data and agree on the necessary registration package to support a new drug application (NDA) submission.

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