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

Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma

Phase 2

Completed

Conditions: Myeloma

Interventions: Drug: Nelfinavir
Drug: bortezomib
Drug: Dexamethasone

First Posted Date: 2014-07-11

Last Posted Date: 2019-06-26

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 34

Registration Number: NCT02188537

Locations: 🇨🇭
Universitaetsspital-Basel, Basel, Switzerland
🇨🇭
Istituto Oncologico Svizzera Italiana IOSI, Bellinzona, Switzerland
🇨🇭
Hopital Fribourgeois, Fribourg, Switzerland

and more 9 locations

Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Liposomal doxorubicin
Drug: Dexamethasone

First Posted Date: 2014-07-10

Last Posted Date: 2023-01-04

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 28

Registration Number: NCT02186834

Locations: 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Phase I/II Study of Carfilzomib, Pomalidomide and Dexamethasone in Relapsed And/Or Refractory Multiple Myeloma Patients (CPD)

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2014-07-10

Last Posted Date: 2023-07-03

Lead Sponsor: Stichting European Myeloma Network

Target Recruit Count: 57

Registration Number: NCT02185820

Locations: 🇮🇹
Dipartimento di Biotecnologie Molecolari e Scienze per la Salute, Torino, Italy

Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas

Phase 1

Completed

Conditions: Lymphoma, T-Cell, Cutaneous
Hodgkin Disease
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse

Interventions: Drug: Romidepsin
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Dexamethasone
Drug: Pegfilgrastim

First Posted Date: 2014-07-03

Last Posted Date: 2020-11-17

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 24

Registration Number: NCT02181218

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Study of Pomalidomide, Cyclophosphamide, Dexamethasone in Relapsed/Refractory Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma, Refractory
Multiple Myeloma in Relapse

Interventions: Drug: Pomalidomide
Drug: Cyclophosphamide
Drug: Dexamethasone

First Posted Date: 2014-06-27

Last Posted Date: 2019-06-18

Lead Sponsor: Ajai Chari

Target Recruit Count: 35

Registration Number: NCT02176213

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients

Phase 4

Withdrawn

Conditions: Post Operative Pain Control

Interventions: Drug: Gabapentin
Drug: Acetaminophen
Drug: Celecoxib
Drug: Dexamethasone
Drug: Oxycodone

First Posted Date: 2014-06-10

Last Posted Date: 2017-05-19

Lead Sponsor: University of North Carolina, Chapel Hill

Registration Number: NCT02160301

Locations: 🇺🇸
UNC Chapel Hill Hospital, Chapel Hill, North Carolina, United States

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Elotuzumab
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2014-06-09

Last Posted Date: 2019-07-16

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 84

Registration Number: NCT02159365

Locations: 🇺🇸
Baptist Health Medical Group Oncology, Miami, Florida, United States
🇺🇸
Investigative Clinical Research Of Indiana, Llc, Indianapolis, Indiana, United States
🇺🇸
Comprehensive Blood And Cancer Center, Bakersfield, California, United States

and more 26 locations

Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery

Phase 2

Terminated

Conditions: Surgery, Hand

Interventions: Drug: Ropivacaine
Other: Placebo
Drug: Dexamethasone

First Posted Date: 2014-06-03

Last Posted Date: 2014-09-11

Lead Sponsor: Duke University

Target Recruit Count: 5

Registration Number: NCT02154048

An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

Phase 2

Completed

Conditions: Immune Thrombocytopenia

Interventions: Drug: Dexamethasone

First Posted Date: 2014-06-02

Last Posted Date: 2016-04-20

Lead Sponsor: Shandong University

Target Recruit Count: 58

Registration Number: NCT02153060

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

Velcade, Thalidomide, Dexamethasone and Panobinostat Treatment and Panobinostat Maintenance in Multiple Myeloma

Phase 1

Conditions: Multiple Myeloma

Interventions: Drug: Velcade
Drug: Thalidomide
Drug: Dexamethasone
Drug: Panobinostat

First Posted Date: 2014-05-23

Last Posted Date: 2015-06-26

Lead Sponsor: Prof Jamie Cavenagh

Target Recruit Count: 54

Registration Number: NCT02145715

Locations: 🇬🇧
Birmingham Heartlands Hospital, Birmingham, UK, United Kingdom
🇬🇧
St Bartholomew's Hospital, London, United Kingdom
🇬🇧
University College London Hospitals NHS Foundation Trust, London, United Kingdom

and more 2 locations

Drug Development Updates

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