Levonorgestrel - Bayer Healthcare Pharmaceuticals
Alternative Names: BAY 865028; Levonorgestrel IUS; Levonova; LNG IUS; LNG-IUS - Bayer; Menopausal levonorgestrel system; Mirena; MLSLatest Information Update: 14 Apr 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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)