Loteprednol etabonate

Drug Profile

Loteprednol etabonate

Alternative Names: Alrex; CDDD-5604; Lotemax; Loteprednol; P-5604

Latest Information Update: 19 Aug 2016

Price : $50

At a glance

  • Originator Pharmos Corporation
  • Developer Bausch & Lomb; IVAX Corporation; Meda
  • Class Androstadienes; Anti-inflammatories; Antiallergics; Eye disorder therapies; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Allergic conjunctivitis; Ocular inflammation
  • Registered Ocular pain
  • Phase II Keratoconjunctivitis sicca
  • Discontinued Allergic asthma; Allergic rhinitis; Skin disorders

Most Recent Events

  • 05 Aug 2016 Meda has been acquired by Mylan
  • 25 May 2016 Valeant Pharmaceuticals plans a phase III trial for Ocular pain and Ocular inflammation in USA (Ophthalmic, Gel) (NCT02786901)
  • 19 May 2016 Launched for Ocular inflammation in Israel (Ophthalmic) before May 2016
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