Zoledronic acid - Axsome Therapeutics

Drug Profile

Zoledronic acid - Axsome Therapeutics

Alternative Names: AXS 02; Disodium (1-Hydroxy-2-(1H-Imidazol-1-yl)-1- Phosphonoethyl)Phosphonic Acid - Axsome Therapeutics; Disodium zoledronate tetrahydrate - Axsome Therapeutics; Oral zoledronate

Latest Information Update: 04 Apr 2018

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At a glance

  • Developer Axsome Therapeutics
  • Class Antineoplastics; Bisphosphonates; Calcium regulators; Imidazoles; Osteoporosis therapies; Small molecules
  • Mechanism of Action Bone resorption factor inhibitors; Geranyltranstransferase inhibitors; Osteoclast inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pain
  • New Molecular Entity No

Highest Development Phases

  • Phase III Pain
  • Phase II Back pain

Most Recent Events

  • 27 Mar 2018 Axsome Therapeutics plans a phase III trial for Back pain (chronic low back pain with modic changes)
  • 09 Jan 2018 Axsome Therapeutics terminates the phase III CREATE-1 trial in Pain in USA, Australia, Canada and United Kingdom (NCT02504008)
  • 01 Feb 2017 Axsome receives IND clearance from the US FDA for its phase III trial in Back pain (10-K, March 2017)
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