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

Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: Oral antiandrogen
Drug: Dexamethasone
Radiation: Radiation therapy
Drug: Prednisone
Drug: LHRH agonist
Drug: docetaxel

First Posted Date: 2006-02-07

Last Posted Date: 2022-06-21

Lead Sponsor: Radiation Therapy Oncology Group

Target Recruit Count: 612

Registration Number: NCT00288080

Locations: 🇺🇸
DeCesaris Cancer Institute at Anne Arundel Medical Center, Annapolis, Maryland, United States
🇺🇸
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
🇺🇸
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States

and more 251 locations

Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

Phase 2

Completed

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Adriblastin
Drug: dexamethasone
Drug: Chlorambucil
Drug: rituximab
Drug: cyclophosphamide
Drug: alkeran
Procedure: Total body irradiation (8Gy/4fr)
Drug: vincristine

First Posted Date: 2006-02-02

Last Posted Date: 2009-02-12

Lead Sponsor: French Innovative Leukemia Organisation

Target Recruit Count: 39

Registration Number: NCT00285389

Locations: 🇫🇷
Regional university hospital, Rennes, France
🇫🇷
REgional Hospital, Tours, France

Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin

First Posted Date: 2006-01-31

Last Posted Date: 2013-02-28

Lead Sponsor: University Hospital, Limoges

Target Recruit Count: 40

Registration Number: NCT00283985

Locations: 🇫🇷
Service d'Hématologie, Evry, France
🇫🇷
Département Maladies du Sang, Angers, France
🇫🇷
CH Annecy, Annecy, France

and more 22 locations

Combination Chemotherapy, Total-Body Irradiation, and Alemtuzumab in Treating Patients Undergoing an Autologous Stem Cell Transplant for Stage I, Stage II, Stage III, or Stage IV Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia

First Posted Date: 2006-01-13

Last Posted Date: 2016-09-26

Lead Sponsor: German CLL Study Group

Target Recruit Count: 30

Registration Number: NCT00276809

Locations: 🇩🇪
Medizinische Hochschule Hannover, Hannover, Germany
🇩🇪
Universitatsklinikum Heidelberg, Heidelberg, Germany
🇩🇪
University Hospital Schleswig-Holstein - Kiel Campus, Kiel, Germany

and more 9 locations

Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

Phase 3

Completed

Conditions: Kidney Failure, Chronic

Interventions: Drug: Thymoglobulin
Drug: Daclizumab
Other: Plasmapheresis
Drug: Mycophenolate mofetil
Drug: Tacrolimus
Drug: Dexamethasone
Drug: Prednisone
Drug: Cytogam

First Posted Date: 2006-01-12

Last Posted Date: 2018-01-18

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 56

Registration Number: NCT00275509

Locations: 🇺🇸
The Johns Hopkins University, School of Medicine, Baltimore, Maryland, United States

Prednisolone or Dexamethasone Combined With Chemotherapy in Treating Young Patients With Newly Diagnosed Lymphoblastic Lymphoma

Phase 3

Terminated

Conditions: Lymphoma

First Posted Date: 2006-01-11

Last Posted Date: 2013-07-10

Lead Sponsor: Children's Cancer and Leukaemia Group

Target Recruit Count: 600

Registration Number: NCT00275106

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, England, United Kingdom
🇬🇧
Royal Manchester Children's Hospital, Manchester, England, United Kingdom
🇩🇪
Kinderklinik, Giessen, Germany

and more 18 locations

Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Biological: filgrastim
Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: etoposide
Drug: fludarabine phosphate
Drug: melphalan
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2006-01-11

Last Posted Date: 2018-05-11

Lead Sponsor: German CLL Study Group

Target Recruit Count: 169

Registration Number: NCT00275015

Locations: 🇩🇪
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, Germany
🇩🇪
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch, Berlin, Germany
🇩🇪
Internistische Praxis - Trier, Trier, Germany

and more 50 locations

Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Myelofibrosis/Myeloproliferative Disorder

Phase 2

Completed

Conditions: Myelodysplastic/Myeloproliferative Diseases
Myelodysplastic Syndromes
Chronic Myeloproliferative Disorders
Leukemia

First Posted Date: 2006-01-11

Last Posted Date: 2020-07-27

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 15

Registration Number: NCT00274820

Locations: 🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection

Phase 3

Completed

Conditions: Surgical Wound Infection
Surgery, Colon

First Posted Date: 2006-01-09

Last Posted Date: 2016-06-29

Lead Sponsor: The Cleveland Clinic

Target Recruit Count: 2000

Registration Number: NCT00273377

Locations: 🇮🇪
Mater Misericordiae Hospital, Dublin, Ireland
🇺🇸
Outcomes Research Institute, Louisville, Kentucky, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 1 locations

Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: dexamethasone
Drug: thalidomide
Drug: zoledronic acid

First Posted Date: 2005-12-08

Last Posted Date: 2011-07-21

Lead Sponsor: Gleneagles Hospital

Target Recruit Count: 56

Registration Number: NCT00263484

Locations: 🇮🇳
Christian Medical College, Vellore, Tamil Nadu, India
🇮🇳
Tata Memorial Hospital, Mumbai, India
🇰🇷
Chonnam National University Hwasun Hospital, Kwangju, Korea, Republic of

and more 7 locations

Drug Development Updates

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