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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 Aug 2026

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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
  • Phase III Endometrial hyperplasia
  • No development reported Menopausal syndrome

Most Recent Events

  • 30 Jul 2026 Bayer withdraws a phase III trial in Endometrial hyperplasia in USA, Canada, China due to enrollment challenges, including difficulties identifying eligible patients, participation requirements, and site burden. The decision was unrelated to safety and does not change Mirena's benefit-risk profile (NCT06904274)
  • 17 Jun 2026 Bayer terminates a phase III trial in Endometrial hyperplasia in USA, Canada, China due to enrollment challenges, including difficulties identifying eligible patients, participation requirements, and site burden. The decision was not safety-related and does not affect Mirena's benefit-risk profile (NCT06904274)
  • 24 Nov 2025 Phase-III clinical trials in Endometrial hyperplasia in USA (Intrauterine) (NCT06904274)

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