Dexamethasone

Generic Name: Dexamethasone

Brand Names: Baycadron, Ciprodex, Decadron, Dexamethasone Intensol, Dextenza, Dioptrol, Hexadrol, Hidex 6-day Taper, Maxidex, Maxitrol, Neofordex, Ozurdex, Taperdex 12 Day Taper, Taperdex 6 Day Taper, Taperdex 7-day Taper, Tobradex, Zcort 7 Day Taper

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₉FO_₅

CAS Number: 50-02-2

Unique Ingredient Identifier: 7S5I7G3JQL

Background: 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

Associated Therapies: -

Clinical Trials

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors

Phase 2

Completed

Conditions: Chemotherapy-Induced Nausea and Vomiting

Interventions: Drug: Fosaprepitant
Drug: Dexamethasone
Drug: 5HT3

First Posted Date: 2012-11-29

Last Posted Date: 2016-05-25

Lead Sponsor: Lawrence Einhorn

Target Recruit Count: 65

Registration Number: NCT01736917

Locations: 🇺🇸
Nebraska Cancer Specialists, Omaha, Nebraska, United States
🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Siteman Cancer Center, St. Louis, Missouri, United States

and more 1 locations

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Pomalidomide
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2012-11-28

Last Posted Date: 2023-06-06

Lead Sponsor: Celgene

Target Recruit Count: 559

Registration Number: NCT01734928

Locations: 🇺🇸
Western Kentucky Hematology and Oncology Group, PSC, Paducah, Kentucky, United States
🇺🇸
Local Institution - 132, Bangor, Maine, United States
🇺🇸
St. Agnes - Medical Center, Baltimore, Maryland, United States

and more 318 locations

Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Phase 3

Withdrawn

Conditions: Purpura
Idiopathic Thrombocytopenic Purpura

Interventions: Drug: recombinant human thrombopoietin (rhTPO); rituximab
Drug: Dexamethasone

First Posted Date: 2012-11-27

Last Posted Date: 2016-04-20

Lead Sponsor: Shandong University

Registration Number: NCT01734057

Locations: 🇨🇳
Qilu Hospital, Shandong University, Jinan, Shandong, China

Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections

Phase 4

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Drug: Dexamethasone
Drug: Placebo

First Posted Date: 2012-11-27

Last Posted Date: 2019-10-15

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 122

Registration Number: NCT01734161

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP

Phase 3

Completed

Conditions: Purpura
Idiopathic Thrombocytopenic Purpura

Interventions: Drug: recombinant human thrombopoietin (rhTPO); dexamethasone
Drug: Dexamethasone

First Posted Date: 2012-11-27

Last Posted Date: 2016-04-20

Lead Sponsor: Shandong University

Target Recruit Count: 158

Registration Number: NCT01734044

Locations: 🇨🇳
Qilu Hospital, Shandong University, Jinan, Shandong, China

Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

Phase 4

Completed

Conditions: Multiple Myeloma

Interventions: Procedure: Autologous peripheral blood stem cell transplant
Drug: Lenalidomide
Procedure: Stem cell collection
Drug: Dexamethasone
Drug: Melphalan
Drug: G-CSF
Drug: Cyclophosphamide
Drug: Mesna

First Posted Date: 2012-11-22

Last Posted Date: 2020-02-05

Lead Sponsor: Columbia University

Target Recruit Count: 60

Registration Number: NCT01731886

Locations: 🇺🇸
Columbia University, New York, New York, United States

Efficacy Study of Dexamethasone to Treat the Acute Respiratory Distress Syndrome

Phase 4

Completed

Conditions: Acute Respiratory Distress Syndrome

Interventions: Drug: Dexamethasone

First Posted Date: 2012-11-22

Last Posted Date: 2019-02-18

Lead Sponsor: Dr. Negrin University Hospital

Target Recruit Count: 277

Registration Number: NCT01731795

Locations: 🇪🇸
Hospital Clinico de Valencia, Valencia, Spain
🇪🇸
Hospital Universitario Dr. Negrin, Las Palmas de Gran Canaria, Spain

First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD

Phase 1

Terminated

Conditions: Light Chain Deposition Disease
Primary Systemic Amyloidosis

Interventions: Drug: pomalidomide
Drug: bortezomib
Drug: dexamethasone
Other: Laboratory Biomarker Analysis

First Posted Date: 2012-11-19

Last Posted Date: 2023-05-09

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 18

Registration Number: NCT01728259

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 2 locations

Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Phase 4

Completed

Conditions: Epithelial Defect After Phototherapeutic Keratectomy

Interventions: Drug: Dexamethasone
Drug: Loteprednol etabonate

First Posted Date: 2012-11-12

Last Posted Date: 2014-03-17

Lead Sponsor: Khon Kaen University

Target Recruit Count: 32

Registration Number: NCT01724892

Locations: 🇹🇭
Onsiri Thanathanee, Khon Kaen, Thailand
🇹🇭
Srinagarind Hospital, Khon Kaen, Thailand

Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma

Phase 1

Completed

Conditions: Retinal Lymphoma
Central Nervous System Lymphoma
Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma
Intraocular Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma

Interventions: Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Pomalidomide

First Posted Date: 2012-11-06

Last Posted Date: 2019-07-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 29

Registration Number: NCT01722305

Locations: 🇺🇸
Dana-Farber Harvard Cancer Center, Boston, Massachusetts, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

and more 4 locations

Drug Development Updates

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