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ParaGard®
ParaGard® is a Intrauterine contraceptive device (copper IUD) Small molecule drug developed by FHI 360. It is currently FDA-approved for Contraception in women of reproductive age. Also known as: ParaGard T 380A.
ParaGard is a copper-containing intrauterine device (IUD) that prevents pregnancy by creating a toxic environment for sperm and inhibiting fertilization and implantation.
ParaGard is a copper-containing intrauterine device (IUD) that prevents pregnancy by creating a toxic environment for sperm and inhibiting fertilization and implantation. Used for Contraception in women of reproductive age.
At a glance
| Generic name | ParaGard® |
|---|---|
| Also known as | ParaGard T 380A |
| Sponsor | FHI 360 |
| Drug class | Intrauterine contraceptive device (copper IUD) |
| Target | Copper ion-mediated spermicidal and anti-implantation effects |
| Modality | Small molecule |
| Therapeutic area | Contraception / Reproductive Health |
| Phase | FDA-approved |
Mechanism of action
The device releases copper ions that are spermicidal and create an inflammatory response in the uterus that is hostile to sperm survival and embryo implantation. This multi-mechanism approach provides long-acting reversible contraception without hormonal effects. The copper-mediated mechanism is non-hormonal, making it suitable for users who cannot tolerate or prefer to avoid hormonal contraceptives.
Approved indications
- Contraception in women of reproductive age
Common side effects
- Increased menstrual bleeding and cramping
- Spotting between periods
- Pelvic pain or discomfort
- Expulsion of device
- Perforation of uterus
Key clinical trials
- A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs) (PHASE3)
- Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard (PHASE3)
- A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive) (PHASE4)
- Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk (PHASE4)
- Long-Acting Reversible Contraception (PHASE4)
- Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ParaGard® CI brief — competitive landscape report
- ParaGard® updates RSS · CI watch RSS
- FHI 360 portfolio CI
Frequently asked questions about ParaGard®
What is ParaGard®?
How does ParaGard® work?
What is ParaGard® used for?
Who makes ParaGard®?
Is ParaGard® also known as anything else?
What drug class is ParaGard® in?
What development phase is ParaGard® in?
What are the side effects of ParaGard®?
What does ParaGard® target?
Related
- Drug class: All Intrauterine contraceptive device (copper IUD) drugs
- Target: All drugs targeting Copper ion-mediated spermicidal and anti-implantation effects
- Manufacturer: FHI 360 — full pipeline
- Therapeutic area: All drugs in Contraception / Reproductive Health
- Indication: Drugs for Contraception in women of reproductive age
- Also known as: ParaGard T 380A
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing