TRALEMENT (cupric sulfate)
Tralement is a combination of four essential trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated for use in adult and pediatric patients weighing at least 10 kg. It serves as a source of these minerals for patients receiving parenteral nutrition when oral or enteral nutrition is impossible, insufficient, or contraindicated. The supplement helps maintain systemic levels of these elements to support essential metabolic and enzymatic functions.
How TRALEMENT Works
Tralement functions by providing exogenous sources of four essential trace elements that act as critical cofactors and structural components: * **Zinc:** Acts as a cofactor for numerous enzymes (including DNA and RNA polymerases) and is essential for protein structural folding and biochemical catalysis, such as carbonic anhydrase activity. * **Copper:** Serves as a cofactor for metalloenzymes acting as oxidases (e.g., cytochrome C oxidase, superoxide dismutase) to facilitate the reduction of molecular oxygen. * **Manganese:** Required for the catalytic activity of various enzyme families, including oxidoreductases and hydrolases, and is a key component of enzymes like manganese superoxide dismutase and arginase. * **Selenium:** Converted in vivo to hydrogen selenide, which serves as a pool for the synthesis of selenoproteins (e.g., glutathione peroxidase and thioredoxins) that manage oxidative stress and metabolic signaling.
Details
- Status
- Prescription
- First Approved
- 2020-07-02
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
Companies
TRALEMENT Approval History
What TRALEMENT Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- Other (1)
TRALEMENT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05661682 | TE20001 | Ph 4 | withdrawn | Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety |
| NCT05677126 | TE20002 | Ph 4 | withdrawn | Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN |
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.
TRALEMENT FDA Label Details
Indications & Usage
FDA Label (PDF)Tralement ® is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Tralement is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid) indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
TRALEMENT Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for TRALEMENT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 30 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • 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.