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

COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Phase 4

Completed

Conditions: Rupture of Anterior Cruciate Ligament

Interventions: Drug: parecoxib, valdecoxib, etoricoxib
Drug: Dexamethasone
Drug: parecoxib, valdecoxib, parecoxib and dexamethasone

First Posted Date: 2011-05-27

Last Posted Date: 2011-05-27

Lead Sponsor: Asker & Baerum Hospital

Target Recruit Count: 93

Registration Number: NCT01361789

Locations: 🇳🇴
Baerum Hospital, Rud, Norway

Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

Phase 4

Completed

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate
Drug: 6-Mercaptopurine
Drug: Rituximab
Drug: Prednisone
Drug: L-asparaginase

First Posted Date: 2011-05-23

Last Posted Date: 2014-05-20

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 100

Registration Number: NCT01358253

Locations: 🇨🇳
Ruijin Hospital, Shanghai, Shanghai, China

PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

Phase 4

Conditions: Acute Lymphoblastic Leukemia

First Posted Date: 2011-05-23

Last Posted Date: 2022-01-19

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 100

Registration Number: NCT01358201

Locations: 🇪🇸
Hospital de Alcorcón, Alcorcón, Spain
🇪🇸
Hospital Germans Trias i Pujol, Badalona, Spain
🇪🇸
Fundación Hospital Alcorcón, Alcorcón, Spain

and more 70 locations

High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Phase 4

Completed

Conditions: Purpura, Thrombocytopenic, Idiopathic

Interventions: Drug: Prednisone
Drug: Dexamethasone

First Posted Date: 2011-05-19

Last Posted Date: 2016-04-20

Lead Sponsor: Shandong University

Target Recruit Count: 261

Registration Number: NCT01356511

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

Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Amrubicin
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Aspirin
Drug: Pegfilgrastim

First Posted Date: 2011-05-18

Last Posted Date: 2018-09-18

Lead Sponsor: Michaela Liedtke

Target Recruit Count: 14

Registration Number: NCT01355705

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: CEP-18770
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2011-05-06

Last Posted Date: 2023-06-28

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Target Recruit Count: 11

Registration Number: NCT01348919

Locations: 🇺🇸
Teva Investigational Site 1, Augusta, Georgia, United States
🇳🇿
Teva Investigational Site 204, Auckland, New Zealand
🇺🇸
Teva Investigational Site 2, Houston, Texas, United States

and more 5 locations

THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)

Phase 2

Completed

Conditions: Multiple Myeloma

First Posted Date: 2011-04-25

Last Posted Date: 2011-04-25

Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Target Recruit Count: 378

Registration Number: NCT01341262

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Phase 3

Completed

Conditions: Chemotherapy-Induced Nausea and Vomiting

Interventions: Drug: Netupitant and Palonosetron
Drug: Palonosetron
Drug: Dexamethasone

First Posted Date: 2011-04-20

Last Posted Date: 2014-11-26

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 1455

Registration Number: NCT01339260

Locations: 🇺🇸
Cancer Specialists of South Texas, P.A., Corpus Christi, Texas, United States
🇺🇸
The John R Marsh Cancer Center, Hagerstown, Maryland, United States
🇺🇸
Compassionate Cancer Centre Medical Group, Fountain Valley, California, United States

and more 168 locations

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Phase 2

Completed

Conditions: Multiple Myeloma
Renal Insufficiency

Interventions: Drug: BHQ880
Drug: BHQ880 Placebo
Drug: bortezomib
Drug: dexamethasone

First Posted Date: 2011-04-19

Last Posted Date: 2020-12-17

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 9

Registration Number: NCT01337752

Locations: 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom
🇺🇸
University Chicago Hospital Dept. of Univ of Chicago (2), Chicago, Illinois, United States
🇺🇸
Medical Oncology Associates, PS, Spokane, Washington, United States

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Lenalidomide
Drug: Dexamethasone
Biological: Elotuzumab (BMS-901608; HuLuc63)

First Posted Date: 2011-04-14

Last Posted Date: 2022-09-30

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 748

Registration Number: NCT01335399

Locations: 🇮🇱
Local Institution - 4959, Kfar Saba, Israel
🇷🇴
Local Institution - 5352, Bucuresti, Romania
🇵🇱
Local Institution - 5254, Gdansk, Poland

and more 232 locations

Drug Development Updates

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