NDAINTRAUTERINESYSTEM
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
MIUDELLA (copper) by Sebela Pharmaceuticals is miudella. First approved in 2025.
Drug data last refreshed 48m ago · AI intelligence enriched 6h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIUDELLA is a copper-containing intrauterine device (IUD) approved by the FDA on February 24, 2025, for contraception. The device prevents pregnancy by interfering with sperm transport and egg fertilization through copper ion release. It represents a non-hormonal, long-acting reversible contraceptive option.
Growth10.3 years to LOE
Early-stage growth product with no current direct competitors creates opportunity for market-building and team expansion within Sebela's contraceptive portfolio.
Mechanism of Action
Miudella. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg.
Pharmacologic Class:
Copper-containing Intrauterine Device
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
Started Jul 2026
120 enrolled
Vaginal Microbial Diversity
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
Started Nov 2024
50 enrolled
Prostate Cancer (Post Prostatectomy)
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
Started Apr 2024
235 enrolled
Prostate CancerProstate AdenocarcinomaBiochemical Recurrence of Malignant Neoplasm of Prostate
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Started Apr 2024
439 enrolled
Prostate CancerProstate Adenocarcinoma
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
Started Jan 2024
1 enrolled
Hepatolenticular Degeneration; Wilson
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.