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

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Phase 2

Completed

Conditions: Anaplastic Large Cell Lymphoma, ALK-Positive
Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma

Interventions: Drug: Crizotinib
Drug: Brentuximab Vedotin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Ifosfamide
Drug: Methotrexate

First Posted Date: 2013-11-08

Last Posted Date: 2024-04-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 137

Registration Number: NCT01979536

Locations: 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸
Valley Children's Hospital, Madera, California, United States
🇺🇸
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States

and more 151 locations

High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP

Phase 2

Withdrawn

Conditions: Immune Thrombocytopenia

Interventions: Drug: Dexamethasone
Drug: Thalidomide

First Posted Date: 2013-11-05

Last Posted Date: 2016-04-20

Lead Sponsor: Shandong University

Registration Number: NCT01976195

Locations: 🇨🇳
Qilu hospital, Shandong University, Jinan, Shandong, China

Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery

Phase 4

Completed

Conditions: Foot and Ankle Procedures

Interventions: Drug: Saline
Drug: Dexamethasone

First Posted Date: 2013-11-03

Last Posted Date: 2016-05-06

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 60

Registration Number: NCT01975285

Locations: 🇺🇸
Cedars Sinai Medical center, Los Angeles, California, United States

Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Thalidomide®
Drug: Cyclophosphamide
Drug: Velcade®
Drug: Dexaméthasone

First Posted Date: 2013-10-29

Last Posted Date: 2015-10-07

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 358

Registration Number: NCT01971658

Locations: 🇫🇷
CHRU - Hôpital A.Michallon, Grenoble, France
🇫🇷
Centre Hospitalier Argenteuil, Argenteuil, France
🇫🇷
Hôpital Avicenne, Bobigny, France

and more 59 locations

Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

Phase 3

Completed

Conditions: Knee Injury

Interventions: Drug: Dexamethasone
Drug: Ropivacaine

First Posted Date: 2013-10-29

Last Posted Date: 2018-12-11

Lead Sponsor: Nationwide Children's Hospital

Target Recruit Count: 77

Registration Number: NCT01971645

Locations: 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States

Study of Carfilzomib in Combination w/Dexamethasone in Patients w/Newly Diagnosed Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Dexamethasone

First Posted Date: 2013-10-25

Last Posted Date: 2017-11-24

Lead Sponsor: Emory University

Target Recruit Count: 1

Registration Number: NCT01969565

Locations: 🇺🇸
Winship Cancer Institute-Emory University, Atlanta, Georgia, United States

A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP

Phase 2

Completed

Conditions: Thrombocytopenia

Interventions: Drug: Oseltamivir
Drug: Dexamethasone

First Posted Date: 2013-10-18

Last Posted Date: 2020-08-25

Lead Sponsor: Shandong University

Target Recruit Count: 96

Registration Number: NCT01965626

Locations: 🇨🇳
Qilu hospital, Shandong University, Jinan, Shandong, China

A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma in Relapse

Interventions: Drug: Panobinostat
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Bortezomib

First Posted Date: 2013-10-18

Last Posted Date: 2021-09-05

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 21

Registration Number: NCT01965353

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Ibrutinib
Drug: Carfilzomib
Drug: Dexamethasone

First Posted Date: 2013-10-14

Last Posted Date: 2021-12-21

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 84

Registration Number: NCT01962792

Locations: 🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
University of California Los Angeles, Los Angeles, California, United States

and more 14 locations

The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery

Phase 4

Completed

Conditions: Pain

Interventions: Other: Placebo
Drug: Dexamethasone
Drug: Morphine
Drug: Zofran
Drug: Paracetamol
Drug: Ibuprofen

First Posted Date: 2013-10-01

Last Posted Date: 2015-10-27

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 160

Registration Number: NCT01953978

Locations: 🇩🇰
Glostrup University Hospital, Glostrup, Denmark

Drug Development Updates

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