MIUDELLA (copper)
Miudella is a copper-containing intrauterine system used to prevent pregnancy in females of reproductive potential. It provides continuous contraceptive protection for a period of up to three years. This device helps patients who are looking for a long-term method to avoid conception.
How MIUDELLA Works
This device works by continuously releasing copper into the uterine cavity. The presence of copper enhances contraceptive effectiveness by interfering with sperm transport and preventing the fertilization of an egg.
Details
- Status
- Prescription
- First Approved
- 2025-02-24
- Patent Cliff
- 2037
- Routes
- INTRAUTERINE
- Dosage Forms
- SYSTEM
MIUDELLA Approval History
What MIUDELLA Treats
1 indicationsMIUDELLA is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prevention of pregnancy
MIUDELLA Boxed Warning
RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare provider...
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare providers are trained on the proper insertion of Miudella prior to first use [see Warnings and Precautions (5.2) ]. WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ]. Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare providers are trained on the proper insertion of Miudella prior to first use [see Warnings and Precautions (5.2) ].
MIUDELLA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MIUDELLA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01777919 GLIODIS | PK-18081973 | Ph 2 | not yet recruiting | Disulfiram/Copper Combination In The Treatment of Newly Diagnosed Glioblastoma Multiform |
| NCT04265274 | BREAST-SK-001 | Ph 2 | withdrawn | Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer. |
| NCT02963051 | Pro00071007 | Ph 1 | terminated | A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIUDELLA FDA Label Details
Indications & Usage
FDA Label (PDF)MIUDELLA is indicated for the treatment of Prevention of pregnancy.
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [se...
MIUDELLA Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for MIUDELLA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 14 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.