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

Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block

Recruiting

Conditions: Heart Block Second Degree
Heart Block Complete

Interventions: Drug: Dexamethasone
Other: No Dexamethasone

First Posted Date: 2020-09-22

Last Posted Date: 2024-05-22

Lead Sponsor: The Hospital for Sick Children

Target Recruit Count: 350

Registration Number: NCT04559425

Locations: 🇧🇬
National Heart Hospital, Sofia, Bulgaria
🇫🇮
Hospital District of Helsinki and Uusimaa, Helsinki, Finland
🇵🇱
Centre of Postgraduate Medical Education Poland, Warsaw, Poland

and more 24 locations

The PRIME Study: A Randomized, Controlled, Prospective Study

Phase 4

Recruiting

Conditions: Patient Preference
Grade of Post-Operative Cystoid Macular Edema
Rate of Post-Operative Cystoid Macular Edema
Patient Outcomes
Post-Operative Inflammation

Interventions: Drug: Topical Prednisolone
Drug: Dextenza

First Posted Date: 2020-09-16

Last Posted Date: 2020-09-16

Lead Sponsor: Vance Thompson Vision - MT

Target Recruit Count: 20

Registration Number: NCT04549935

Locations: 🇺🇸
Briana Parker, Bozeman, Montana, United States

Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis

Phase 1

Active, not recruiting

Conditions: Hemophagocytic Lymphohistiocytosis

Interventions: Drug: Ruxolitinib
Drug: Dexamethasone
Drug: Etoposide

First Posted Date: 2020-09-16

Last Posted Date: 2024-08-28

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 62

Registration Number: NCT04551131

Locations: 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
John Hopkins University, Baltimore, Maryland, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States

and more 10 locations

Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

Early Phase 1

Completed

Conditions: Post Operative Nausea and Vomiting

Interventions: Drug: Dexamethasone
Drug: Mirtazapine 30 MG

First Posted Date: 2020-09-14

Last Posted Date: 2024-10-08

Lead Sponsor: Ain Shams University

Target Recruit Count: 90

Registration Number: NCT04547842

Locations: 🇪🇬
Ain Shams University, Cairo, Abassia, Egypt

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Phase 2

Suspended

Conditions: Down Syndrome
Recurrent B Acute Lymphoblastic Leukemia

Interventions: Procedure: Biospecimen Collection
Radiation: 3-Dimensional Conformal Radiation Therapy
Biological: Blinatumomab
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cytarabine
Drug: Dexamethasone
Drug: Calaspargase Pegol
Drug: Hydrocortisone Sodium Succinate
Procedure: Lumbar Puncture
Drug: Methotrexate
Biological: Nivolumab
Drug: Mercaptopurine
Drug: Pegaspargase
Drug: Pegcrisantaspase
Drug: Vincristine Sulfate

First Posted Date: 2020-09-14

Last Posted Date: 2024-10-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 300

Registration Number: NCT04546399

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Corewell Health Dearborn Hospital, Dearborn, Michigan, United States
🇺🇸
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States

and more 200 locations

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Phase 4

Recruiting

Conditions: Acute Hypoxemic Respiratory Failure

Interventions: Drug: Dexamethasone

First Posted Date: 2020-09-10

Last Posted Date: 2024-02-20

Lead Sponsor: Dr. Negrin University Hospital

Target Recruit Count: 980

Registration Number: NCT04545242

Locations: 🇪🇸
Hospital Clínic (Hepatic ICU), Barcelona, Spain
🇪🇸
Hospital Universitario de Cruces (Anesthesia), Barakaldo, Vizcaya, Spain
🇪🇸
Hospital Universitario del Henares (ICU), Coslada, Madrid, Spain

and more 37 locations

Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

Phase 4

Terminated

Conditions: Pain, Postoperative

Interventions: Drug: Dexamethasone
Drug: Analgesics

First Posted Date: 2020-09-09

Last Posted Date: 2024-12-27

Lead Sponsor: Duke University

Target Recruit Count: 24

Registration Number: NCT04541147

Locations: 🇺🇸
Duke University Medical Center and affiliated practices, Durham, North Carolina, United States

Sterile Amniotic Fluid Filtrate Epidural Injection.

Phase 1

Recruiting

Conditions: Lumbar Spinal Stenosis

Interventions: Drug: Amniotic Fluid Allograft
Drug: Dexamethasone sodium phosphate

First Posted Date: 2020-09-03

Last Posted Date: 2024-12-10

Lead Sponsor: University of Utah

Target Recruit Count: 112

Registration Number: NCT04537026

Locations: 🇺🇸
University of Utah Orthopaedic Center, Salt Lake City, Utah, United States

Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency

Phase 4

Conditions: Congenital Adrenal Hyperplasia

Interventions: Drug: Hydrocortisone
Drug: Dexamethasone
Drug: Prednisone

First Posted Date: 2020-09-02

Last Posted Date: 2020-09-02

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 120

Registration Number: NCT04536662

Locations: 🇨🇳
Ruijin hospital,Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma

Conditions: Relapsed and/or Refractory Multiple Myeloma

First Posted Date: 2020-09-01

Last Posted Date: 2021-03-18

Lead Sponsor: Oncopeptides AB

Registration Number: NCT04534322

Locations: 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸
Gabrail Cancer Center, Canton, Ohio, United States
🇺🇸
Texas Oncology, Dallas, Texas, United States

and more 8 locations

Drug Development Updates

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