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

Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Lymphoblastic Leukemia
Philadelphia Chromosome-Positive

Interventions: Biological: Blinatumomab
Drug: dasatinib
Drug: dexamethasone
Drug: methotrexate

First Posted Date: 2020-04-01

Last Posted Date: 2024-07-24

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 17

Registration Number: NCT04329325

Locations: 🇺🇸
Mount Sinai Hospital, New York, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia

Phase 2

Completed

Conditions: COVID-19

Interventions: Drug: Dexamethasone
Drug: Siltuximab

First Posted Date: 2020-04-01

Last Posted Date: 2023-09-21

Lead Sponsor: Judit Pich Martínez

Target Recruit Count: 163

Registration Number: NCT04329650

Locations: 🇪🇸
Hospital Universitari Mútua de Terrassa, Terrassa, Spain
🇪🇸
Hospital Universitario de Salamanca, Salamanca, Spain
🇪🇸
Hospital Clínic de Barcelona, Barcelona, Spain

and more 1 locations

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial

Phase 3

Active, not recruiting

Conditions: COVID-19

Interventions: Drug: LSALT Peptide
Drug: Artesunate
Drug: Imatinib
Drug: Infliximab
Drug: Dexamethasone

First Posted Date: 2020-04-01

Last Posted Date: 2023-10-13

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 2900

Registration Number: NCT04330690

Locations: 🇨🇦
Health Sciences Centre, Winnipeg, Manitoba, Canada
🇨🇦
Trillium Health Partners -Mississauga Site, Mississauga, Ontario, Canada
🇨🇦
Grey Nuns Community Hospital, Edmonton, Alberta, Canada

and more 50 locations

COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III

Phase 3

Terminated

Conditions: Coronavirus Infection
Pneumonia, Viral
Acute Respiratory Distress Syndrome

Interventions: Drug: Dexamethasone

First Posted Date: 2020-03-31

Last Posted Date: 2020-08-07

Lead Sponsor: Hospital Sirio-Libanes

Target Recruit Count: 299

Registration Number: NCT04327401

Locations: 🇧🇷
Fundação Social Rural de Colatina, Colatina, Esoírito Santo, Brazil
🇧🇷
Hospital Maternidade E Pronto Socorro Santa Lucia Ltda, Poços De Caldas, Minas Gerais, Brazil
🇧🇷
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil

and more 18 locations

Role of Dexamethasone in Multimodal Analgesia for Postoperative Pain in Thoracic Surgery

Completed

Conditions: Dexamethasone Adverse Reaction
Analgesia
Postoperative Pain
Postoperative Thoracic Procedure Complication

Interventions: Drug: Dexamethasone

First Posted Date: 2020-03-30

Last Posted Date: 2020-03-30

Lead Sponsor: University of Trieste

Target Recruit Count: 62

Registration Number: NCT04325984

Locations: 🇮🇹
Cattinara Hospital, Trieste, Italy

Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19

Phase 4

Terminated

Conditions: Acute Respiratory Distress Syndrome Caused by COVID-19

Interventions: Drug: Dexamethasone

First Posted Date: 2020-03-27

Last Posted Date: 2021-02-03

Lead Sponsor: Dr. Negrin University Hospital

Target Recruit Count: 19

Registration Number: NCT04325061

Locations: 🇪🇸
Intensive Care Unit, Hospital Universitario La Paz, Madrid, Spain
🇪🇸
AVI, Hospital Clinic, Barcelona, Spain
🇪🇸
Department of Anesthesia, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain

and more 21 locations

Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia

Conditions: Immune Thrombocytopenia

Interventions: Drug: Dexamethasone

First Posted Date: 2020-03-24

Last Posted Date: 2020-09-09

Lead Sponsor: Shandong University

Target Recruit Count: 60

Registration Number: NCT04320225

A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation

Phase 2

Recruiting

Conditions: Gastric Cancer
Stomach Cancer

Interventions: Drug: Paclitaxel
Drug: Carboplatin
Drug: Dexamethasone
Drug: Diphenhydramine
Drug: Famotidine
Drug: Palonosetron
Radiation: 3D conformal or intensity modulated radiotherapy
Procedure: Surgical resection
Radiation: Adjuvant Chemotherapy

First Posted Date: 2020-03-16

Last Posted Date: 2023-11-14

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 29

Registration Number: NCT04308837

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Mount Sinai St. Luke's, New York, New York, United States
🇺🇸
Mount Sinai West, New York, New York, United States

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

Phase 2

Recruiting

Conditions: Relapse Multiple Myeloma
Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Drug: Daratumumab SC
Drug: Clarithromycin
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2020-03-10

Last Posted Date: 2024-06-26

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 40

Registration Number: NCT04302324

Locations: 🇺🇸
Weill Cornell Medicine - Multiple Myeloma Center, New York, New York, United States

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Drug: Farletuzumab ecteribulin
Drug: Prednisone
Drug: Prednisolone
Drug: Dexamethasone

First Posted Date: 2020-03-09

Last Posted Date: 2024-12-09

Lead Sponsor: Eisai Inc.

Target Recruit Count: 142

Registration Number: NCT04300556

Locations: 🇺🇸
Chattanooga's Program In Women's Oncology, Chattanooga, Tennessee, United States
🇺🇸
Arizona Clinical Research Center - Hunt - PPDS, Tucson, Arizona, United States
🇺🇸
University of Arkansas For Medical Sciences, Little Rock, Arkansas, United States

and more 50 locations

Drug Development Updates

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