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

S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: bendamustine hydrochloride
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate

First Posted Date: 2011-08-09

Last Posted Date: 2021-10-29

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 53

Registration Number: NCT01412879

Locations: 🇺🇸
Illinois CancerCare - Galesburg, Galesburg, Illinois, United States
🇺🇸
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
🇺🇸
Wenatchee Valley Medical Center, Wenatchee, Washington, United States

and more 200 locations

Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis

Phase 3

Completed

Conditions: Blepharitis

Interventions: Other: Vehicle
Drug: Azasite
Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Drug: Dexamethasone

First Posted Date: 2011-08-03

Last Posted Date: 2021-11-19

Lead Sponsor: Sun Pharmaceutical Industries Limited

Target Recruit Count: 917

Registration Number: NCT01408082

Locations: 🇺🇸
Eye Research Foundation, Newport Beach, California, United States
🇺🇸
Macy Eye Center, Los Angeles, California, United States
🇺🇸
Center for Sight, Inc., Fall River, Massachusetts, United States

and more 38 locations

Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)

Phase 2

Terminated

Conditions: Vomiting
Nausea

Interventions: Drug: Fosaprepitant dimeglumine
Drug: 5-HT3 RA
Drug: Dexamethasone
Drug: Rescue medication

First Posted Date: 2011-07-29

Last Posted Date: 2018-08-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 111

Registration Number: NCT01405924

Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Phase 1

Completed

Conditions: Childhood T Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Lymphoblastic Lymphoma

Interventions: Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Pegaspargase
Other: Pharmacological Study
Drug: Temsirolimus
Drug: Vincristine Sulfate

First Posted Date: 2011-07-27

Last Posted Date: 2015-07-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT01403415

Locations: 🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States
🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
C S Mott Children's Hospital, Ann Arbor, Michigan, United States

and more 28 locations

Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2011-07-26

Last Posted Date: 2021-03-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT01402284

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Dexamethasone Versus Depo Medrol in Lumbar Epidurals

Not Applicable

Terminated

Conditions: Lumbar Back Pain
Lumbar Spine Disc Herniation
Lumbar Radiculitis

Interventions: Drug: methylprednisolone acetate
Drug: Dexamethasone

First Posted Date: 2011-07-19

Last Posted Date: 2023-11-22

Lead Sponsor: State University of New York - Upstate Medical University

Target Recruit Count: 8

Registration Number: NCT01397552

Locations: 🇺🇸
Upstate Orthpedics, East Syracuse, New York, United States

Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM)

Phase 1

Completed

Conditions: Multiple Myeloma in Relapse

Interventions: Drug: Vorinostat
Drug: Bortezomib
Drug: Doxorubicin
Drug: Dexamethasone

First Posted Date: 2011-07-14

Last Posted Date: 2016-04-06

Lead Sponsor: University Hospital Freiburg

Target Recruit Count: 34

Registration Number: NCT01394354

Locations: 🇩🇪
University Medical Center Freiburg, Freiburg, Germany

Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

Phase 1

Completed

Conditions: Multiple Myeloma

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

First Posted Date: 2011-07-14

Last Posted Date: 2017-08-03

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 35

Registration Number: NCT01393964

Locations: 🇺🇸
University Of Maryland, Baltimore, Maryland, United States
🇺🇸
Investigative Clinical Research Of Indiana, Llc, Indianapolis, Indiana, United States
🇺🇸
Tennessee Oncology, Pllc, Nashville, Tennessee, United States

and more 8 locations

Corticosteroids for Children With Febrile Urinary Tract Infections

Phase 3

Completed

Conditions: Urinary Tract Infection
Acute Urinary Tract Infection

Interventions: Drug: Placebo
Drug: Dexamethasone

First Posted Date: 2011-07-12

Last Posted Date: 2019-07-02

Lead Sponsor: Nader Shaikh

Target Recruit Count: 546

Registration Number: NCT01391793

Locations: 🇺🇸
Nationwide Children's Hospital in Columbus, Columbus, Ohio, United States
🇺🇸
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
Primary Children's Hospital, Salt Lake City, Utah, United States

and more 3 locations

Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2011-06-28

Last Posted Date: 2019-03-21

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 64

Registration Number: NCT01383928

Locations: 🇺🇸
Virginia Cancer Specialists PC, Fairfax, Virginia, United States
🇺🇸
Ohio State University, Columbus, Ohio, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 17 locations

Drug Development Updates

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