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Dexamethasone sodium phosphate injectable gel - Scilex Holding

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Drug Profile

Dexamethasone sodium phosphate injectable gel - Scilex Holding

Alternative Names: Dexamethasone sodium phosphate viscous gel; SEMDEXA; SP 102

Latest Information Update: 15 Jan 2024

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At a glance

  • Originator Semnur Pharmaceuticals
  • Developer Scilex Holding
  • Class Anti-inflammatories; Antiallergics; Antiemetics; Antihyperglycaemics; Antineoplastics; Antirheumatics; Eye disorder therapies; Fluorinated steroids; Glucocorticoids; Ketones; Non-opioid analgesics; Phosphates; Pregnadienetriols; Small molecules; Sodium compounds; Steroids; Vestibular disorder therapies
  • Mechanism of Action Glucocorticoid receptor agonists; Immunosuppressants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Sciatica

Most Recent Events

  • 02 Nov 2023 Scilex plans a clinical trial for Sciatica (Epidural, Injection) in the first half of 2024
  • 02 Nov 2023 Scilex announces intention to submit NDA to the US FDA for Sciatica utilizing the 505(b) regulatory pathway
  • 02 Nov 2023 Scilex Holding Company announces a positive Type C meeting with the US FDA reaching agreement on the advancement of clinical development of dexamethasone sodium phosphate injectable gel and on the requirements to file a new NDA

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