FDA · United States
dexamethasone sodium phosphate — FDA regulatory status
dexamethasone sodium phosphate (DEXAMETHASONE SODIUM PHOSPHATE) 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
- DEXAMETHASONE SODIUM PHOSPHATE
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Glucocorticoid receptor agonist
- Target
- Glucocorticoid receptor
- Structured fields
- 8
Sponsor / originator context: Amneal Pharma Europe Ltd. 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: Glucocorticoid receptor agonist. Target: Glucocorticoid receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 169 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 |
|---|---|---|---|
| 20190009 | Phase 3 | Amgen | 2023-508214-42-00 |
| 20190360 | Phase 3 | Amgen | 2023-503640-14-00 |
| 20200041 | Phase 3 | Amgen | 2023-505989-29-00 |
| 20230016 | Phase 3 | Amgen | 2023-506235-15-00 |
| 207495 | Phase 3 | GSK Glaxo Smith | 2023-508962-14-00 |
| 207499 | Phase 3 | GSK Glaxo Smith | 2023-506877-37-00 |
| 207503 | Phase 3 | GSK Glaxo Smith | 2023-510537-28-00 |
| 214828 | Phase 3 | GSK Glaxo Smith | 2024-516030-35-00 |
| 54767414MMY3019 | Phase 3 | Janssen-Cilag International N.V | 2023-507312-13-00 |
| 64007957MMY3005 | Phase 3 | Janssen-Cilag International N.V | 2023-503442-30-00 |
| 64007957MMY3006 | Phase 3 | Janssen-Cilag International N.V | 2023-503444-13-00 |
| 64407564MMY3002 | Phase 3 | Janssen-Cilag International N.V | 2023-503467-41-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12331126 | OX40-binding polypeptides and uses thereof | US |
| 12311059 | Process for the preparation of erythrocytes loaded with one or more substances of pharmaceutical interest and so obtained erythrocytes | US |
| 12285435 | Multivesicular liposome formulations of dexamethasone | US |
| 12084502 | CD33-binding polypeptides and uses thereof | US |
| 12043667 | CLEC12a binding polypeptides and uses thereof | US |
| 12012459 | OX40-binding polypeptides and uses thereof | US |
| 11965017 | Serpin fusion polypeptides and methods of use thereof | US |
| 11919963 | CD123-binding polypeptides and uses thereof | US |
| 11866507 | Multispecific polypeptide constructs having constrained CD3 binding and methods of using the same | US |
| 11827691 | Serpin fusion polypeptides and methods of use thereof | US |
| 11566078 | PDL1-binding proteins | US |
| 11560428 | CD33-binding polypeptides and uses thereof | US |
Related hubs
FAQ
What is the FDA approval status of dexamethasone sodium phosphate?
dexamethasone sodium phosphate 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 dexamethasone sodium phosphate 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 dexamethasone sodium phosphate?
This spoke lists 169 published programs associated with dexamethasone sodium phosphate in our pipeline index.