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

Diuretic Efficacy of Dexamethasone in Heart Failure

Phase 1

Suspended

Conditions: Heart Failure, Congestive

First Posted Date: 2005-12-08

Last Posted Date: 2008-07-04

Lead Sponsor: Hebei Medical University

Target Recruit Count: 60

Registration Number: NCT00263302

Locations: 🇨🇳
Kunshen Liu, Shijiazhuang, Hebei, China
🇨🇳
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2

Terminated

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia

Interventions: Biological: alemtuzumab
Drug: asparaginase
Drug: methotrexate
Drug: dexamethasone
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: vincristine

First Posted Date: 2005-12-07

Last Posted Date: 2015-05-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT00262925

Locations: 🇺🇸
Mercy Hospital and Medical Center, Chicago, Illinois, United States
🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸
Rush - Copley Medical Center, Aurora, Illinois, United States

and more 55 locations

Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma

Phase 2

Conditions: Lymphoma, Mantle-Cell

First Posted Date: 2005-12-05

Last Posted Date: 2006-10-18

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 16

Registration Number: NCT00261612

Locations: 🇦🇹
Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology, Vienna, Austria

Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

Phase 1

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Dietary Supplement: ascorbic acid
Drug: arsenic trioxide
Drug: bortezomib
Drug: dexamethasone
Drug: thalidomide
Drug: Aspirin

First Posted Date: 2005-11-24

Last Posted Date: 2013-04-29

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 5

Registration Number: NCT00258245

Locations: 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation

Phase 3

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Velcade (Bortezomib)
Drug: Thalidomide
Drug: Dexamethasone

First Posted Date: 2005-11-22

Last Posted Date: 2021-10-18

Lead Sponsor: European Society for Blood and Marrow Transplantation

Target Recruit Count: 269

Registration Number: NCT00256776

Locations: 🇧🇪
Saint Joseph, Gilly, Belgium
🇨🇭
Stadtdpital Triemli, Zurich, Switzerland
🇦🇹
Medizinische Universitaet Wien, Vienna, Austria

and more 70 locations

RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer

Phase 1

Terminated

Conditions: Breast Cancer

Interventions: Drug: Docetaxel
Drug: RAD001
Drug: Dexamethasone

First Posted Date: 2005-11-15

Last Posted Date: 2023-10-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT00253318

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

Phase 2

Completed

Conditions: Waldenstrom's Macroglobulinemia

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Rituximab

First Posted Date: 2005-11-09

Last Posted Date: 2016-04-08

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 23

Registration Number: NCT00250926

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach

Phase 2

Terminated

Conditions: Non-Hodgkin's Lymphoma
Cancer

Interventions: Drug: Vincristine
Drug: VP-16
Drug: Rituximab
Drug: Dexamethasone
Drug: Levofloxacin

First Posted Date: 2005-11-08

Last Posted Date: 2015-08-03

Lead Sponsor: New Mexico Cancer Care Alliance

Target Recruit Count: 17

Registration Number: NCT00250718

Locations: 🇺🇸
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

Not Applicable

Completed

Conditions: Cancer

Interventions: Drug: dexamethasone
Drug: aprepitant
Drug: ondansetron
Drug: placebo

First Posted Date: 2005-11-04

Last Posted Date: 2017-05-09

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 40

Registration Number: NCT00248547

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer

Phase 2

Completed

Conditions: Stage IV Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer

Interventions: Drug: Gemcitabine
Drug: Carboplatin
Drug: Dexamethasone

First Posted Date: 2005-11-01

Last Posted Date: 2014-03-07

Lead Sponsor: Susanne Arnold

Target Recruit Count: 60

Registration Number: NCT00247416

Locations: 🇺🇸
Markey Cancer Center, Lexington, Kentucky, United States
🇺🇸
St. Claire Regional Medical Center, Morehead, Kentucky, United States
🇺🇸
Commonwealth Cancer Center, Danville, Kentucky, United States

and more 4 locations

Drug Development Updates

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