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

Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

Not Applicable

Completed

Conditions: Post Surgical Pain

Interventions: Drug: Bupivacaine 0.25%
Drug: Dexamethasone
Drug: normal saline

First Posted Date: 2012-09-24

Last Posted Date: 2017-05-04

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 89

Registration Number: NCT01690663

Locations: 🇺🇸
Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States

Hydroxychloroquine, Cyclophosphamide, Dexamethasone, and Sirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Hydroxychloroquine
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Sirolimus

First Posted Date: 2012-09-21

Last Posted Date: 2017-09-07

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 18

Registration Number: NCT01689987

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

Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, for the Treatment of Patients With Relapsed Myeloma

Phase 1

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2012-09-18

Last Posted Date: 2013-04-05

Lead Sponsor: Gruppo Italiano Studio Linfomi

Target Recruit Count: 60

Registration Number: NCT01686386

Locations: 🇮🇹
U. O. C. Ematologia - Azienda Ospedaliera Cosenza, Cosenza, Italy

Dovitinib Combined With Bortezomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Phase 1

Withdrawn

Conditions: Multiple Myeloma

Interventions: Drug: Dovitinib
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2012-09-07

Last Posted Date: 2013-02-20

Lead Sponsor: University of Florida

Registration Number: NCT01680796

Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

Phase 3

Completed

Conditions: Interaction Between Antiemetic Drugs and Paracetamol

Interventions: Drug: ondansetron
Drug: Droperidol
Drug: Dexamethasone

First Posted Date: 2012-09-05

Last Posted Date: 2016-10-27

Lead Sponsor: University Hospital, Lille

Target Recruit Count: 66

Registration Number: NCT01679093

Locations: 🇫🇷
Hôpital Claude Huriez, CHRU, Lille, France

A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Dexamethasone

First Posted Date: 2012-09-03

Last Posted Date: 2022-09-23

Lead Sponsor: Amgen

Target Recruit Count: 116

Registration Number: NCT01677858

Locations: 🇺🇸
California Cancer Associates for Research and Excellence, Fresno, California, United States
🇺🇸
James R. Berenson M.D. Inc., West Hollywood, California, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 30 locations

Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Phase 1

Completed

Conditions: Stress

Interventions: Drug: Metyrapone
Drug: Dexamethasone
Drug: Cortrosyn
Drug: Corticorelin ovine triflutate

First Posted Date: 2012-08-27

Last Posted Date: 2018-04-23

Lead Sponsor: University of Michigan

Target Recruit Count: 256

Registration Number: NCT01673087

Locations: 🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States

A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: ASP7487, Velcade, Dexamethasone

First Posted Date: 2012-08-27

Last Posted Date: 2018-09-13

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 19

Registration Number: NCT01672736

Locations: 🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
University Of Chicago Medical Center, Chicago, Illinois, United States
🇨🇦
Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada

and more 3 locations

Dexamethasone Dyspnea Study

Phase 2

Completed

Conditions: Advanced Cancers
Hematologic Disorder
Solid Tumors

Interventions: Drug: Dexamethasone
Behavioral: Questionnaires
Drug: Placebo
Device: Spirometer
Other: Phone Calls

First Posted Date: 2012-08-21

Last Posted Date: 2021-02-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 52

Registration Number: NCT01670097

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

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

Phase 2

Withdrawn

Conditions: Blastic Phase Chronic Myelogenous Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
B-cell Adult Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions: Drug: nilotinib
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: methotrexate
Drug: cytarabine
Drug: prednisone
Drug: mesna
Drug: dexamethasone
Drug: leucovorin calcium

First Posted Date: 2012-08-21

Last Posted Date: 2015-10-30

Lead Sponsor: Mayo Clinic

Registration Number: NCT01670084

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Drug Development Updates

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