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 Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

Phase 1

Completed

Conditions: Primary Mediastinal B-cell Lymphoma (PMBCL)
Transformed Follicular Lymphoma (TFL)
High Grade B-cell Lymphoma (HGBCL)
Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Relapsed Diffuse Large B-Cell Lymphoma

Interventions: Biological: Axicabtagene Ciloleucel
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Levetiracetam
Drug: Tocilizumab
Drug: Dexamethasone
Drug: Doxorubicin
Drug: High-dose methylprednisolone
Drug: Prednisone
Drug: Bendamustine
Drug: Vincristine
Drug: Rituximab
Drug: Ifosfamide
Drug: Carboplatin
Drug: Methylprednisolone
Drug: Etoposide
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Cisplatin

First Posted Date: 2015-01-28

Last Posted Date: 2024-06-04

Lead Sponsor: Kite, A Gilead Company

Target Recruit Count: 307

Registration Number: NCT02348216

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
University of California Los Angeles (UCLA), Santa Monica, California, United States
🇨🇦
Princess Margaret, Toronto, Ontario, Canada

and more 33 locations

Protracted Effect of the Ultrasound-guided Saphenous Block

Phase 4

Completed

Conditions: Arthrosis, Unspecified, Ankle and Foot

Interventions: Drug: Bupivacaine-adrenaline
Other: Sodium chloride
Drug: Dexamethasone

First Posted Date: 2015-01-26

Last Posted Date: 2016-02-12

Lead Sponsor: University of Aarhus

Target Recruit Count: 40

Registration Number: NCT02346110

Locations: 🇩🇰
Department of Anesthesiology, Aarhus University Hospital, Aarhus, Midtjylland, Denmark

Selinexor and Backbone Treatments of Multiple Myeloma Patients

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Bortezomib
Drug: Lenalidomide
Drug: Daratumumab
Drug: Carfilzomib
Drug: Ixazomib
Drug: Belantamab Mafodotin
Drug: Mezigdomide
Drug: Elotuzumab
Drug: Clarithromycin

First Posted Date: 2015-01-21

Last Posted Date: 2024-05-07

Lead Sponsor: Karyopharm Therapeutics Inc

Target Recruit Count: 300

Registration Number: NCT02343042

Locations: 🇺🇸
Sarah Cannon-Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Swedish Cancer Institute, Seattle, Washington, United States

and more 21 locations

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

Phase 3

Active, not recruiting

Conditions: Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA

Interventions: Drug: Arsenic Trioxide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Idarubicin
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Tretinoin

First Posted Date: 2015-01-15

Last Posted Date: 2024-11-07

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 158

Registration Number: NCT02339740

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸
Rady Children's Hospital - San Diego, San Diego, California, United States
🇺🇸
Naval Medical Center -San Diego, San Diego, California, United States

and more 171 locations

Selinexor Treatment of Refractory Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Dexamethasone

First Posted Date: 2015-01-13

Last Posted Date: 2023-01-26

Lead Sponsor: Karyopharm Therapeutics Inc

Target Recruit Count: 202

Registration Number: NCT02336815

Locations: 🇺🇸
Jonnsson Comprehensive Cancer Center / University of Los Angeles, Los Angeles, California, United States
🇺🇸
Hackensack University Medical Center / John Therurer Cancer Center, Hackensack, New Jersey, United States
🇺🇸
Sylvester, University of Miami, Miami, Florida, United States

and more 58 locations

Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2015-01-12

Last Posted Date: 2020-11-06

Lead Sponsor: Amgen

Target Recruit Count: 107

Registration Number: NCT02335983

Locations: 🇺🇸
Saint Francis Hospital Cancer Center, Greenville, South Carolina, United States
🇺🇸
Greenville Health System, Greenville, South Carolina, United States
🇺🇸
Morton Coleman, MD, New York, New York, United States

and more 27 locations

Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia

Phase 3

Completed

Conditions: Purpura, Thrombocytopenic, Idiopathic

Interventions: Drug: Dexamethasone
Drug: Prednisone

First Posted Date: 2015-01-08

Last Posted Date: 2017-06-09

Lead Sponsor: University Hospital, Essen

Target Recruit Count: 26

Registration Number: NCT02334813

Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Biological: Isatuximab
Drug: Carfilzomib
Drug: Dexamethasone

First Posted Date: 2015-01-07

Last Posted Date: 2024-04-01

Lead Sponsor: Thomas Martin, MD

Target Recruit Count: 83

Registration Number: NCT02332850

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States

and more 3 locations

Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study

Early Phase 1

Completed

Conditions: Distal Radius Fracture
Osteoarthritis

Interventions: Drug: Saline
Drug: Dexamethasone

First Posted Date: 2014-12-17

Last Posted Date: 2020-04-13

Lead Sponsor: Mayo Clinic

Target Recruit Count: 43

Registration Number: NCT02318433

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Dexamethasone and Wound Healing After Thyroid Surgery

Not Applicable

Completed

Conditions: Wound Infection

Interventions: Drug: saline
Drug: Dexamethasone

First Posted Date: 2014-12-01

Last Posted Date: 2015-11-30

Lead Sponsor: Quanhong Zhou

Target Recruit Count: 220

Registration Number: NCT02304250

Locations: 🇨🇳
Shanghai 6Th People'S Hospital, Shanghai, Shanghai, China

Drug Development Updates

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