MAXIDEX (dexamethasone sodium phosphate) · Novartis
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Details
- Status
- Discontinued
- First Approved
- 1962-06-20
- Routes
- OPHTHALMIC
- Dosage Forms
- OINTMENT, SUSPENSION/DROPS
MAXIDEX Approval History
What MAXIDEX Treats
9 indicationsMAXIDEX is approved for 9 conditions since its original approval in 1962. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammatory Conditions
- Allergic Conjunctivitis
- Acne Rosacea
- Superficial Punctate Keratitis
- Herpes Zoster Keratitis
- Iritis
- Cyclitis
- Infective Conjunctivitis
- Corneal Injury
MAXIDEX 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.
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Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
11 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 |
| NCT00881673 | C-09-005 | Ph 2 | withdrawn | To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge |
| NCT01030601 IDDMECS | IDDMECS | Ph 2 | completed | Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) |
| NCT00631358 results posted | ORE 14351 | Ph 4 | completed | Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention |
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.
MAXIDEX FDA Label Details
Indications & Usage
FDA Label (PDF)Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.