Drug intelligence / Profile preview

miudella

Development stage
Approved
Lead developer
Sebela Pharmaceuticals
Modality
Covalent Small Molecules → Small Molecules, DNA Intercalators/Alkylators → Nucleic Acid-Directed Small Molecules → Small Molecules, Light/Condition-Responsive Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
Administration
Intrauterine
01

Overview

Miudella is a next-generation, hormone-free, low-dose copper intrauterine device (IUD) approved by the FDA in 2025 for the prevention of pregnancy in females of reproductive potential for up to three years. It consists of a small and flexible nitinol frame with super-elastic properties and less than half the amount of copper compared to currently available U.S. copper IUDs. The device continuously releases a small amount of copper into the uterine cavity, which interferes with sperm transport and fertilization without affecting ovulation. Miudella is inserted by a healthcare professional and must be removed or replaced after three years. It is available only through a restricted REMS program to ensure proper insertion technique due to risks associated with improper placement. Common adverse reactions include heavy menstrual bleeding, dysmenorrhea (painful periods), intermenstrual bleeding, pelvic discomfort or pain, procedural pain or hemorrhage, post-procedural hemorrhage, and dyspareunia (pain during intercourse). Clinical trials demonstrated high contraceptive efficacy (99% over 3 years) with favorable tolerability[1][2][4][5][6][7][8].

Brand names
Miudella
Other names
copper intrauterine systemcopper IUDcopper intrauterine devicelow-dose copper IUD

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