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

Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

Phase 3

Completed

Conditions: Leukemia
Lymphoma

Interventions: Biological: filgrastim
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: etoposide
Drug: methotrexate
Drug: ifosfamide
Drug: vincristine sulfate

First Posted Date: 2003-05-21

Last Posted Date: 2013-08-21

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 83

Registration Number: NCT00005977

Locations: 🇺🇸
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
🇺🇸
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
🇺🇸
Texas Oncology P.A., Dallas, Texas, United States

and more 116 locations

A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

Phase 2

Completed

Conditions: Liposarcoma
Leiomyosarcoma

Interventions: Drug: Yondelis
Drug: Dexamethasone

First Posted Date: 2003-05-19

Last Posted Date: 2014-09-08

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Target Recruit Count: 271

Registration Number: NCT00060944

Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma

Phase 1

Completed

Conditions: Lymphoma, Low-Grade
Lymphoma, Small Lymphocytic
Lymphoma, Small Cleaved-Cell, Follicular
Lymphoma, Mixed-Cell, Follicular

First Posted Date: 2003-05-12

Last Posted Date: 2015-01-19

Lead Sponsor: CTI BioPharma

Target Recruit Count: 30

Registration Number: NCT00060684

Locations: 🇺🇸
Greater Baltimore Medical Center, Baltimore, Maryland, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Arizona Clinical Research Center, Tucson, Arizona, United States

and more 1 locations

Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: Colorectal Cancer
Metastatic Cancer

Interventions: Drug: FOLFOX regimen
Drug: dexamethasone
Drug: floxuridine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery

First Posted Date: 2003-05-07

Last Posted Date: 2024-07-03

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 38

Registration Number: NCT00059930

Locations: 🇺🇸
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

Phase 3

Completed

Conditions: Fatigue
Anemia
Prostate Cancer

First Posted Date: 2003-05-07

Last Posted Date: 2023-06-15

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 282

Registration Number: NCT00060398

Locations: 🇺🇸
Mercy Hospital and Medical Center, Chicago, Illinois, United States
🇺🇸
Swedish Covenant Hospital, Chicago, Illinois, United States
🇺🇸
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States

and more 137 locations

Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: filgrastim
Drug: cytarabine
Drug: cyclophosphamide
Drug: methotrexate
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate

First Posted Date: 2003-04-25

Last Posted Date: 2018-11-14

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 19

Registration Number: NCT00003311

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

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: CC-5013
Drug: Dexamethasone

First Posted Date: 2003-03-07

Last Posted Date: 2017-10-19

Lead Sponsor: Celgene

Target Recruit Count: 353

Registration Number: NCT00056160

Locations: 🇺🇸
Ohio State University, Columbus, Ohio, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Clinical Research Consultants, Inc., Hoover, Alabama, United States

and more 46 locations

Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

Phase 2

Completed

Conditions: Prostate Cancer

First Posted Date: 2003-02-06

Last Posted Date: 2011-03-08

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 15

Registration Number: NCT00054522

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-02-06

Last Posted Date: 2022-10-03

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 24

Registration Number: NCT00054158

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma

Phase 3

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-20

Lead Sponsor: Lymphoma Trials Office

Target Recruit Count: 500

Registration Number: NCT00006250

Locations: 🇬🇧
St. Thomas' Hospital, London, England, United Kingdom
🇬🇧
Birmingham Heartlands Hospital, Birmingham, England, United Kingdom
🇬🇧
Craigavon Area Hospital, Craigavon, Northern Ireland, United Kingdom

and more 56 locations

Drug Development Updates

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