CALCIUM GLUCONATE IN SODIUM CHLORIDE (calcium gluconate) · HQ SPCLT PHARMA
Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-06-15
- Patent Cliff
- 2037
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
CALCIUM GLUCONATE IN SODIUM CHLORIDE Approval History
What CALCIUM GLUCONATE IN SODIUM CHLORIDE Treats
1 indicationsCALCIUM GLUCONATE IN SODIUM CHLORIDE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypocalcemia
Same approved indications as CALCIUM GLUCONATE (same active ingredient).
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05958342 CAVALIER | STUDY23040043 W81XWH-6-D-0024 | Ph 2 | recruiting | CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial |
| NCT05953376 | 3115 | Ph 3 | withdrawn | Empiric Calcium in Massive Transfusion |
| NCT07217899 | HUM00259931 | Ph 2 | recruiting | Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony |
| NCT06820645 CALM | 15231 | Ph 2, Ph 3 | not yet recruiting | Calcium Administration in Life-saving Management During Massive Hemorrhage |
| NCT01099449 results posted | N08CB NCCTG-N08CB, CDR0000669660 | Ph 3 | completed | Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy |
| NCT04958044 | eCaEP2021 | Ph 1 | completed | Endoscopic Assisted Calcium Electroporation in Esophageal Cancer |
| NCT02875587 | Cabergoline/calcium gluconate | Ph 2 | completed | Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome |
| NCT03473613 | Ashraf Elmantwe 1 | Ph 3 | completed | Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention |
| NCT00998738 results posted | RC08CC NCI-2009-01229, RC08CC | Ph 3 | terminated | Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast 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.
CALCIUM GLUCONATE IN SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established. • Calcium Gluconate in Sodium Chloride Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. • Limitations of Use: The safety of Calcium Gluconate Injection for long term use has not been established.
CALCIUM GLUCONATE IN SODIUM CHLORIDE Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 22 active patents
Trial Analysis
- • 9 total trials
- • Stage: Expansion
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment