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Levonorgestrel - Bayer Healthcare Pharmaceuticals

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Drug Profile

Levonorgestrel - Bayer Healthcare Pharmaceuticals

Alternative Names: BAY 865028; Levonorgestrel IUS; Levonova; LNG IUS; LNG-IUS - Bayer; Menopausal levonorgestrel system; Mirena; MLS

Latest Information Update: 14 Apr 2025

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At a glance

  • Originator Schering Oy
  • Developer Bayer HealthCare Pharmaceuticals
  • Class Hormonal contraceptives; Hormonal replacements; Norpregnanes; Progesterone congeners; Small molecules
  • Mechanism of Action Progesterone receptor agonists
  • 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

  • Marketed Menorrhagia; Pregnancy; Uterine diseases
  • No development reported Menopausal syndrome

Most Recent Events

  • 08 Apr 2025 Bayer plans the phase III SUNFLOWER trial for Endometrial hyperplasia (In adolescents, In adults, In the elderly) in USA, China (Intrauterine), in June 2025 , (NCT06904274)
  • 16 May 2023 Efficacy data from a clinical trial in menorrhagia released by Bayer
  • 19 Aug 2022 The US FDA approves a supplemental new drug application (sNDA) of intrauterine device 52mg levonorgestrel-releasing intrauterine system for up to 8 years in Pregnancy (Prevention) in USA (Intrauterine)

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