DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE (dexamethasone sodium phosphate)
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is indicated for the treatment of Adrenocortical Insufficiency; Acute Adrenocortical Insufficiency; Congenital Adrenal Hyperplasia; Nonsuppurative Thyroiditis; Hypercalcemia associated with cancer; Post-Traumatic Osteoarthritis; Synovitis; Rheumatoid Arthritis; Acute Bursitis; Epicondylitis.
Details
- Status
- Prescription
- First Approved
- 2003-04-11
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Approval History
What DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Treats
10 indicationsDEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is approved for 10 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Acute Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Nonsuppurative Thyroiditis
- Hypercalcemia associated with cancer
- Post-Traumatic Osteoarthritis
- Synovitis
- Rheumatoid Arthritis
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06664853 OLE_NEAT results posted | IEDAT-05-2024 | Ph 3 | terminated | Open-Label Extension of EryDex Study IEDAT-04-2022 |
| NCT06193200 NEAT results posted | IEDAT-04-2022 | Ph 3 | completed | Evaluate the Neurological Effects of EryDex on Subjects With A-T |
| NCT03031730 results posted | NCI-2017-00099 NCI-2017-00099, NCI10076 | Ph 1 | terminated | Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma |
| NCT04537026 | IRB 131761 | Ph 1, Ph 2 | completed | Sterile Amniotic Fluid Filtrate Epidural Injection. |
| NCT06951087 | 2019-K068 81974129, 82171038, 82101101 | Ph 3 | enrolling by invitation | Intravitreal and Intracameral DEX in NPDR |
| NCT03606980 results posted | CHKDSM-001 | Ph 2 | terminated | Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics |
| NCT03332316 | R17104M 2017-002185-51 | Ph 4 | completed | Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery |
| NCT02421419 results posted | IRB - 001858 | Ph 4 | terminated | Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture |
| NCT01030601 IDDMECS | IDDMECS | Ph 2 | completed | Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) |
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.
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is indicated for the treatment of Adrenocortical Insufficiency; Acute Adrenocortical Insufficiency; Congenital Adrenal Hyperplasia; Nonsuppurative Thyroiditis; Hypercalcemia associated with cancer; Post-Traumatic Osteoarthritis; Synovitis; Rheumatoid Arthritis; Acute Bursitis; Epicondylitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.