Overview
Dexamethasone, or MK-125, is a corticosteroid fluorinated at position 9 used to treat endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Developed in 1957, it is structurally similar to other corticosteroids like hydrocortisone and prednisolone. Dexamethasone was granted FDA approval on 30 October 1958. In a press release for the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial on 16 June 2020, dexamethasone was recommended for use in COVID-19 patients with severe respiratory symptoms. Dexamethasone reduced deaths by approximately one third in patients requiring ventilation and by one fifth in those requiring oxygen.
Indication
Dexamethasone and ciprofloxacin otic suspension is indicated for bacterial infections with inflammation in acute otitis media and acute otitis externa. Intramuscular and intravenous injections are indicated for a number of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Oral tablets are indicated for the treatment of multiple myeloma. An intravitreal implant is indicated for some forms of macular edema and non-infectious posterior uveitis affecting the posterior of the eye. Various ophthalmic formulations are indicated for inflammatory conditions of the eye.
Associated Conditions
- Acute Gouty Arthritis
- Acute Leukemia
- Acute Otitis Externa
- Acute Otitis Media (AOM)
- Adrenocortical Hyperfunction
- Adrenocortical Insufficiency
- Allergic Conjunctivitis (AC)
- Alopecia Areata (AA)
- Ankylosing Spondylitis (AS)
- Aspiration Pneumonitis
- Asthma
- Atopic Dermatitis
- Berylliosis
- Bullous dermatitis herpetiformis
- Bursitis
- Chorioretinitis
- Choroiditis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Conjunctivitis
- Contact Dermatitis
- Cushing's Syndrome
- Dermatitis
- Diabetic Macular Edema (DME)
- Discoid Lupus Erythematosus (DLE)
- Drug hypersensitivity reaction
- Edema of the cerebrum
- Epicondylitis
- Episcleritis
- Erythroblastopenia
- Eye Infections
- Eye allergy
- Glaucoma
- Hypercalcemia
- Immune Thrombocytopenia (ITP)
- Infection
- Inflammation
- Inflammation of the External Auditory Canal
- Intraocular Inflammation
- Iridocyclitis
- Iritis
- Keloids Scars
- Keratitis
- Lichen Planus (LP)
- Lichen simplex chronicus
- Loeffler's syndrome
- Lymphoma
- Macular Edema
- Meningitis caused by Mycobacterium Tuberculosis
- Middle ear inflammation
- Mucosal Inflammation of the eye
- Multiple Myeloma (MM)
- Muscle Inflammation caused by Cataract Surgery of the eye
- Mycosis Fungoides (MF)
- Necrobiosis lipoidica diabeticorum
- Non-infectious Posterior Uveitis
- Ocular Infections, Irritations and Inflammations
- Ocular Inflammation
- Ocular Inflammation and Pain
- Ocular Irritation
- Ocular Itching
- Ophthalmia, Sympathetic
- Optic Neuritis
- Otitis Externa
- Pemphigus
- Perennial Allergic Rhinitis (PAR)
- Phlyctenular keratoconjunctivitis
- Postoperative Infections of the eyes caused by susceptible bacteria
- Posttraumatic Osteoarthritis
- Regional Enteritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Rosacea
- Sarcoidosis
- Scleritis
- Seasonal Allergic Rhinitis
- Secondary thrombocytopenia
- Serum Sickness
- Severe Seborrheic Dermatitis
- Stevens-Johnson Syndrome
- Synovitis
- Systemic Lupus Erythematosus
- Tenosynovitis
- Trichinosis
- Tuberculosis (TB)
- Ulcerative Colitis
- Uveitis
- Vernal Keratoconjunctivitis
- Acquired immune hemolytic anemia
- Acute rheumatic carditis
- Anterior eye segment inflammation
- Corticosteroid-responsive dermatoses
- Ear infection-not otherwise specified caused by susceptible bacteria
- Exfoliative erythroderma
- Granuloma annulare lesions
- Non-suppurative Thyroiditis
- Ocular bacterial infections
- Severe Psoriasis
- Steroid-responsive inflammation of the eye
- Swelling of the eyes
- Varicella-zoster virus acute retinal necrosis
- Watery itchy eyes
Research Report
Dexamethasone (DB01234): A Comprehensive Pharmacological and Clinical Monograph
Executive Summary
Dexamethasone is a potent, long-acting synthetic glucocorticoid that has been a cornerstone of medical therapy for over six decades. First granted regulatory approval in 1958 [1], this small molecule drug (DrugBank ID: DB01234; CAS: 50-02-2) has demonstrated remarkable therapeutic longevity and versatility. Its clinical utility is rooted in powerful anti-inflammatory and immunosuppressive actions, which are mediated primarily through agonism of the intracellular glucocorticoid receptor.[2] This interaction modulates the expression of a vast network of genes, leading to the suppression of pro-inflammatory pathways and the enhancement of anti-inflammatory signals.
The therapeutic scope of dexamethasone is exceptionally broad, spanning numerous medical disciplines. It is an established treatment for a wide array of endocrine, rheumatic, allergic, dermatologic, and hematologic disorders.[3] In oncology, it serves a dual role as both a direct cytotoxic agent in hematological malignancies, most notably multiple myeloma, and as an indispensable supportive care medication for managing treatment-related complications such as cerebral edema and chemotherapy-induced nausea and vomiting.[5] Its enduring relevance was dramatically highlighted during the COVID-19 pandemic, where it was identified as a life-saving intervention for patients with severe respiratory disease, capable of mitigating the hyperinflammatory response that drives acute respiratory distress syndrome.[1]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/23 | Phase 4 | Recruiting | Poznan University of Medical Sciences | ||
2025/01/23 | Phase 4 | Recruiting | Poznan University of Medical Sciences | ||
2025/01/23 | Phase 2 | Recruiting | |||
2025/01/22 | Phase 4 | Completed | |||
2025/01/21 | Phase 1 | Recruiting | |||
2025/01/20 | Phase 1 | Recruiting | |||
2025/01/06 | Not Applicable | Completed | Minia University | ||
2024/12/30 | Phase 4 | Not yet recruiting | |||
2024/12/24 | Phase 4 | Not yet recruiting | |||
2024/12/19 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0799 | AURICULAR (OTIC) | 1 mg in 1 mL | 4/19/2022 | |
| Physicians Total Care, Inc. | 54868-6099 | INTRAVENOUS, INTRAMUSCULAR | 10 mg in 1 mL | 11/5/2010 | |
| Proficient Rx LP | 71205-012 | ORAL | 1.5 mg in 1 1 | 3/1/2020 | |
| Eugia US LLC | 55150-239 | INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, SOFT TISSUE | 4 mg in 1 mL | 2/16/2024 | |
| ANI Pharmaceuticals, Inc. | 70954-404 | ORAL | 6 mg in 1 1 | 3/4/2024 | |
| A-S Medication Solutions | 50090-2313 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 12/3/2018 | |
| ANI Pharmaceuticals, Inc. | 70954-401 | ORAL | 1.5 mg in 1 1 | 3/4/2024 | |
| Bryant Ranch Prepack | 63629-7850 | ORAL | 1 mg in 1 1 | 6/27/2020 | |
| Blenheim Pharmacal, Inc. | 10544-212 | ORAL | 4 mg in 1 1 | 3/17/2015 | |
| Proficient Rx LP | 71205-330 | OPHTHALMIC | 1 mg in 1 g | 1/1/2021 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dexamethasone Acetate Tablets | 国药准字H20056794 | 化学药品 | 片剂 | 6/19/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H14021843 | 化学药品 | 片剂 | 7/28/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H41022697 | 化学药品 | 片剂 | 4/15/2025 | |
| Dexamethasone Acetate Tablets | 国药准字H32021354 | 化学药品 | 片剂 | 7/30/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H41020174 | 化学药品 | 片剂 | 6/9/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H45020246 | 化学药品 | 片剂 | 8/13/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H45020490 | 化学药品 | 片剂 | 8/18/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H22022035 | 化学药品 | 片剂 | 8/21/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H44022312 | 化学药品 | 片剂 | 9/29/2020 | |
| Dexamethasone Acetate Tablets | 国药准字H21023243 | 化学药品 | 片剂 | 8/26/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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