Triamcinolone acetonide sustained-release - Flexion Therapeutics

Drug Profile

Triamcinolone acetonide sustained-release - Flexion Therapeutics

Alternative Names: FX-006; Zilretta

Latest Information Update: 16 Feb 2017

Price : $50

At a glance

  • Originator Flexion Therapeutics
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antipsoriatics; Antirheumatics; Eye disorder therapies; Fluorinated steroids; Glucocorticoids; Pregnadienes; Small molecules
  • Mechanism of Action Cytokine inhibitors; Glucocorticoid receptor agonists; Matrix metalloproteinase inhibitors
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Musculoskeletal pain
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Musculoskeletal pain
  • Phase II Osteoarthritis

Most Recent Events

  • 07 Feb 2017 FDA assigns PDUFA action date of 06/10/2017 for triamcinolone acetonide sustained-release for Musculoskeletal pain (associated with knee osteoarthritis)
  • 07 Feb 2017 US FDA accepts NDA for triamcinolone acetonide sustained-release for Musculoskeletal pain (associated with knee osteoarthritis) for review
  • 06 Feb 2017 Flexion Therapeutics plans a phase III trial for Musculoskeletal pain (associated with knee osteoarthritis) in USA (Intra-articular) (NCT03046446)
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