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

Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: ACY-241
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2015-03-27

Last Posted Date: 2024-07-09

Lead Sponsor: Celgene

Target Recruit Count: 85

Registration Number: NCT02400242

Locations: 🇺🇸
Gabrail Cancer Center Research, Canton, Ohio, United States
🇺🇸
University of Miami Medical Center, Miami, Florida, United States
🇺🇸
Local Institution - 104, Boston, Massachusetts, United States

and more 14 locations

Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia

Phase 2

Completed

Conditions: Waldenstrom's Macroglobulinemia

Interventions: Drug: Ixazomib
Drug: Dexamethasone
Drug: Rituximab

First Posted Date: 2015-03-27

Last Posted Date: 2020-09-02

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 26

Registration Number: NCT02400437

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Phase 3

Completed

Conditions: Leukemia, Acute Lymphoblastic

Interventions: Drug: Dexamethasone
Drug: Blinatumomab
Drug: Vincrisitne
Drug: Daunorubicin
Drug: Methotrexate
Drug: Ifosfamide
Drug: PEG-asparaginase
Drug: Erwinia-asparaginase

First Posted Date: 2015-03-20

Last Posted Date: 2024-05-29

Lead Sponsor: Amgen

Target Recruit Count: 111

Registration Number: NCT02393859

Locations: 🇬🇧
Research Site, Sutton, United Kingdom

Study of Selinexor (KPT- 330), Lenalidomide, & Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

Phase 1

Withdrawn

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2015-03-17

Last Posted Date: 2023-01-26

Lead Sponsor: Karyopharm Therapeutics Inc

Registration Number: NCT02389543

Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant

Phase 2

Active, not recruiting

Conditions: Plasma Cell Myeloma
Residual Disease

Interventions: Drug: Ixazomib Citrate
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2015-03-17

Last Posted Date: 2024-08-15

Lead Sponsor: University of Chicago

Target Recruit Count: 42

Registration Number: NCT02389517

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

Prevention of POV After Paediatric Tonsillectomy

Phase 4

Completed

Conditions: Vomiting

Interventions: Device: Acupuncture
Drug: Dexamethasone

First Posted Date: 2015-03-13

Last Posted Date: 2016-01-22

Lead Sponsor: Assiut University

Target Recruit Count: 120

Registration Number: NCT02387918

Locations: 🇪🇬
Faculty of Medicine Assuit University, Egypt, Assuit, Egypt

Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Alemtuzumab
Drug: Etoposide
Drug: Dexamethasone
Drug: Methotrexate
Behavioral: Phone Call
Drug: Tocilizumab

First Posted Date: 2015-03-11

Last Posted Date: 2024-01-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT02385110

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia

Phase 4

Conditions: Postoperative Nausea and Vomiting

Interventions: Drug: Dexamethasone + Ondansetron
Drug: PLACEBO
Drug: Ondansetron
Drug: Dexamethasone

First Posted Date: 2015-03-11

Last Posted Date: 2015-03-11

Lead Sponsor: University of Catania

Target Recruit Count: 1200

Registration Number: NCT02386059

Locations: 🇮🇹
Federico II University, Naples, Italy
🇮🇹
Polytechnic University of Marche, Ancona, Marche, Italy
🇮🇹
University of Catania, Catania, Sicily, Italy

and more 1 locations

Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Not Applicable

Withdrawn

Conditions: Malignant Neoplasm
Ototoxicity

Interventions: Drug: Dexamethasone
Other: Placebo
Drug: Cisplatin

First Posted Date: 2015-03-06

Last Posted Date: 2017-11-09

Lead Sponsor: Aaron Moberly

Registration Number: NCT02382068

Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Lenalidomide
Drug: Elotuzumab
Drug: Bortezomib
Drug: Dexamethasone
Procedure: Stem Cell Mobilization

First Posted Date: 2015-03-02

Last Posted Date: 2024-09-30

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 40

Registration Number: NCT02375555

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

and more 4 locations

Drug Development Updates

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