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 With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Acute Undifferentiated Leukemia
Acute Lymphoblastic Leukemia
Childhood T Acute Lymphoblastic Leukemia

Interventions: Drug: Asparaginase
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Procedure: Echocardiography
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Lestaurtinib
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Procedure: Multigated Acquisition Scan
Drug: Pegaspargase
Other: Pharmacological Study
Drug: Prednisone
Drug: Therapeutic Hydrocortisone
Drug: Vincristine Sulfate

First Posted Date: 2007-11-12

Last Posted Date: 2024-07-15

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 218

Registration Number: NCT00557193

Locations: 🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

and more 167 locations

Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

Phase 2

Completed

Conditions: Diffuse Large B-Cell Lymphoma
POOR PROGNOSIS

Interventions: Drug: Rituximab
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Prednisone
Drug: Granulocyte-colony-stimulating factor
Drug: Mitoxantrone
Drug: Cytarabine ARA-C
Drug: Dexamethasone
Drug: Carmustine BCNU
Drug: Etoposide
Drug: Melphalan
Radiation: Radiotherapy
Procedure: PBSC reinfusion

First Posted Date: 2007-11-09

Last Posted Date: 2007-11-09

Lead Sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Target Recruit Count: 94

Registration Number: NCT00556127

Locations: 🇮🇹
Centro Trapianti Midollo Osseo, P.O. Businco, Cagliari, Italy
🇮🇹
Ospedale S. Gerardo, Monza, Italy
🇮🇹
Osp. maggiore della Carità, Novara, Italy

and more 11 locations

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: PD 0332991

First Posted Date: 2007-11-09

Last Posted Date: 2015-03-19

Lead Sponsor: Pfizer

Target Recruit Count: 53

Registration Number: NCT00555906

Locations: 🇺🇸
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
🇺🇸
Barnes-Jewish Hospital, St. Louis, Missouri, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

and more 15 locations

Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

First Posted Date: 2007-11-07

Last Posted Date: 2019-11-12

Lead Sponsor: Celgene

Target Recruit Count: 15

Registration Number: NCT00555100

Locations: 🇯🇵
Keio University Hospital, Tokyo, Japan
🇯🇵
Niigata Cancer Center Hospital, Niigata, Japan
🇯🇵
National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan

and more 2 locations

Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

Phase 3

Completed

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

Interventions: Drug: dexamethasone
Drug: dronabinol
Drug: palonosetron hydrochloride
Other: placebo

First Posted Date: 2007-11-04

Last Posted Date: 2020-10-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 62

Registration Number: NCT00553059

Locations: 🇺🇸
University of Texas M.D. Anderson, Houston, Texas, United States
🇺🇸
CCOP - Greenville, Greenville, South Carolina, United States
🇺🇸
Cancer Research for the Ozarks, Springfield, Missouri, United States

and more 1 locations

Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: dexamethasone
Drug: thalidomide
Drug: lenalidomide

First Posted Date: 2007-10-03

Last Posted Date: 2018-06-06

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 5

Registration Number: NCT00538824

Locations: 🇺🇸
Weill Medical College of Cornell University, New York, New York, United States

Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: thalomid
Drug: lenalidomide
Drug: clarithromycin
Drug: dexamethasone

First Posted Date: 2007-10-03

Last Posted Date: 2021-05-24

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 26

Registration Number: NCT00538733

Locations: 🇺🇸
Weill Medical College of Cornell University, New York, New York, United States

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma

Phase 1

Completed

Conditions: Renal Cancer
Lymphoma
Non-small Cell Lung Cancer
Solid Tumors
Ovarian Cancer
Small Cell Lung Cancer
Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Dexamethasone

First Posted Date: 2007-09-18

Last Posted Date: 2017-08-15

Lead Sponsor: Amgen

Target Recruit Count: 184

Registration Number: NCT00531284

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Tower Cancer Research Foundation, Beverly Hills, California, United States
🇺🇸
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States

and more 4 locations

Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease

Phase 3

Terminated

Conditions: Anemia, Sickle Cell

Interventions: Drug: Dexamethasone
Drug: Placebo

First Posted Date: 2007-09-17

Last Posted Date: 2013-04-09

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 12

Registration Number: NCT00530270

Locations: 🇺🇸
University of California - Davis, Sacramento, California, United States
🇺🇸
Kosair Children's Hospital, Louisville, Kentucky, United States
🇺🇸
Children's Hospital Boston, Boston, Massachusetts, United States

and more 3 locations

LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Phase 4

Completed

Conditions: Acute Lymphoblastic Leukemia

First Posted Date: 2007-09-10

Last Posted Date: 2010-01-05

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 100

Registration Number: NCT00526305

Locations: 🇪🇸
Hospital General de Segovia, Segovia, Spain
🇪🇸
Hospital Universitario de Canarias, Tenerife, Spain
🇪🇸
H.U. Virgen del Rocio, Sevilla, Spain

and more 46 locations

Drug Development Updates

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