FDA · United States
calcium chloride — FDA regulatory status
calcium chloride (DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
- Mechanism
- Dihydrofolate reductase inhibitor
- Structured fields
- 7
Sponsor / originator context: Regeneron Ireland Designated Activity Company (DAC). Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Dihydrofolate reductase inhibitor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 91 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 0.2 mg/kg ketamine | Phase 3 | United Therapeutics Europe | NCT02418702 |
| 2.0 mg intravitreal aflibercept | Phase 3 | Regeneron UK | NCT01627249 |
| 20200041 | Phase 3 | Amgen | 2023-505989-29-00 |
| 25% AgNO3 solution followed by 5% NaF | Phase 3 | University of Hong | NCT03423797 |
| APHP200073 | Phase 3 | PARItec | 2024-516018-39-00 |
| APHP230864 | Phase 3 | PARItec | 2024-510943-76-00 |
| GTX-102-CL302 | Phase 3 | Anaxis Pharma | 2024-510917-14-00 |
| ION 682884, ION 682884 | Phase 3 | IONIS PHARMACEUTICALS | 2024-511201-32-00 |
| ION-682884-CS2 | Phase 3 | IONIS PHARMACEUTICALS | 2024-514434-20-00 |
| LUM | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT03601637 |
| NA_00090926 | Phase 3 | United Therapeutics Europe | NCT02367521 |
| Once weekly subcutaneous injection of TransCon hGH | Phase 3 | Ascendis Pharma | NCT02781727 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
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| 2023077094 | TRAITEMENT D'UN TROUBLE DÉPRESSIF MAJEUR | WO |
| 2023130736 | METHODS OF TREATING MIGRAINE | US |
| 11622968 | Heterocyclic modulators of lipid synthesis | US |
| 11612608 | Methods of treating oral mucositis | US |
| 11598782 | Biomarkers and methods for detection of seizures and epilepsy | US |
| 2022380379 | PHARMACEUTICAL COMPOUNDS | US |
| 2021387969 | BICYCLIC AZA COMPOUNDS AS MUSCARINIC M1 AND/OR M4 RECEPTOR AGONISTS | US |
| 3177686 | COMPOSITIONS COMPRENANT DE LA TROPOELASTINE RETICULEE A DE L'ACIDE HYALURONIQUE ET LEURS PROCEDES D'UTILISATION | CA |
Related hubs
FAQ
What is the FDA approval status of calcium chloride?
calcium chloride currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get calcium chloride regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to calcium chloride?
This spoke lists 91 published programs associated with calcium chloride in our pipeline index.