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

Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Lenalidomide
Drug: dexamethasone

First Posted Date: 2006-09-19

Last Posted Date: 2024-11-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 68

Registration Number: NCT00378105

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

Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: perifosine
Drug: dexamethasone

First Posted Date: 2006-09-13

Last Posted Date: 2018-02-28

Lead Sponsor: AEterna Zentaris

Target Recruit Count: 67

Registration Number: NCT00375791

Locations: 🇺🇸
Investigative Site, Charlottesville, Virginia, United States

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

First Posted Date: 2006-08-18

Last Posted Date: 2012-04-06

Lead Sponsor: Accelerated Community Oncology Research Network

Target Recruit Count: 32

Registration Number: NCT00366106

Locations: 🇺🇸
Augusta Oncology Associates, PC, Augusta, Georgia, United States
🇺🇸
Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States
🇺🇸
Mid Ohio Oncology/Hematology, Inc., Columbus, Ohio, United States

and more 12 locations

Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

Phase 3

Completed

Conditions: Primary Systemic Amyloidosis (AL)

First Posted Date: 2006-06-26

Last Posted Date: 2007-06-28

Lead Sponsor: University Hospital, Limoges

Target Recruit Count: 100

Registration Number: NCT00344526

Locations: 🇫🇷
Service d'hématologie clinique, Nantes, France
🇫🇷
Hématologie Clinique, Tours, France
🇫🇷
Service d'immuno-hématologie, Hôpital Saint-Louis, Paris, France

and more 5 locations

Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

Not Applicable

Conditions: Leukemia

First Posted Date: 2006-06-23

Last Posted Date: 2013-08-26

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 550

Registration Number: NCT00343369

Locations: 🇩🇪
Dr. von Haunersches Kinderspital der Universitaet Muenchen, Munich, Germany
🇩🇪
Kreskrankenhaus Kinderabteilung, Heide, Germany
🇩🇪
Universitaets - Kinderklinik, Leipzig, Germany

and more 13 locations

Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

Not Applicable

Completed

Conditions: Male Breast Cancer
Nausea and Vomiting
Stage IIIA Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer

Interventions: Drug: cyclophosphamide
Drug: palonosetron hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Procedure: quality-of-life assessment
Procedure: nausea and vomiting therapy
Procedure: management of therapy complications
Drug: ondansetron hydrochloride
Other: survey administration

First Posted Date: 2006-06-23

Last Posted Date: 2017-07-11

Lead Sponsor: University of Washington

Target Recruit Count: 41

Registration Number: NCT00343863

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

Phase 3

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Nausea and Vomiting

Interventions: Drug: APF530
Drug: dexamethasone
Drug: Palonosetron Hydrochloride
Other: placebo

First Posted Date: 2006-06-23

Last Posted Date: 2017-02-23

Lead Sponsor: Heron Therapeutics

Target Recruit Count: 1428

Registration Number: NCT00343460

Locations: 🇺🇸
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
Palo Verde Hematology Oncology - Glendale, Glendale, Arizona, United States
🇺🇸
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States

and more 49 locations

Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

First Posted Date: 2006-06-16

Last Posted Date: 2006-06-16

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 50

Registration Number: NCT00337506

Locations: 🇫🇷
Jean-Luc HAROUSSEAU, Nantes, France

Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2006-06-09

Last Posted Date: 2013-01-09

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 101

Registration Number: NCT00335348

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

Phase 2

Terminated

Conditions: Lymphoma

Interventions: Biological: Rituximab
Drug: Cytarabine
Drug: Dexamethasone
Drug: Leucovorin
Drug: Methotrexate
Drug: Procarbazine
Drug: Vincristine

First Posted Date: 2006-06-08

Last Posted Date: 2023-07-03

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 26

Registration Number: NCT00335140

Locations: 🇺🇸
West Michigan Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
🇺🇸
Bronson Methodist Hospital, Kalamazoo, Michigan, United States

and more 65 locations

Drug Development Updates

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