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A phase 3 study of KETABET

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A phase 3 study of KETABET

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2021

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At a glance

  • Drugs Ketamine+betaine microneedle patch (Primary)
  • Indications Depressive disorders
  • Focus Therapeutic Use

    • Most Recent Events

    • 19 Oct 2021 According to a PharmaTher media release, the company has entered in to an agreement with Alcalmi Corporation (CDMO) for manufacturing of the ketamine products for FDA Phase 3 clinical studies and global commercialization, supply expected in H2-2022.
    • 20 Sep 2021 New trial record
    • 13 Sep 2021 According to a PharmaTher media release, if the Phase 2 clinical study is positive, the company will request a meeting with the FDA to discuss its plan and obtain an agreement to move this phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.

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