MIRENA

Peak

levonorgestrel

NDAINTRAUTERINESYSTEM
Approved
Dec 2000
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
24

Mechanism of Action

demonstrated. Studies of Mirena and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium .

Pharmacologic Class:

Progestin

Clinical Trials (5)

NCT07272889Phase 1Not Yet Recruiting

Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)

Started Dec 2025
NCT06904274Phase 3Recruiting

Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months

Started Nov 2025
207 enrolled
Endometrial Hyperplasia
NCT07013643Phase 1Recruiting

A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

Started Jun 2025
75 enrolled
Healthy Participants
NCT06942936Phase 1Completed

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

Started May 2025
51 enrolled
Healthy Participants
NCT06657105Phase 1Completed

A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential

Started Nov 2024
22 enrolled
Healthy Participants

Loss of Exclusivity

LOE Date
Sep 16, 2029
43 months away
Patent Expiry
Sep 16, 2029

Patent Records (2)

Patent #ExpiryTypeUse Code
11850182
Sep 14, 2029
Product
U-3819
10561524
Sep 16, 2029
U-2948