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

Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery

Phase 4

Withdrawn

Conditions: Post Operative Pain

Interventions: Drug: Dexamethasone

First Posted Date: 2019-03-15

Last Posted Date: 2023-09-26

Lead Sponsor: Henry Ford Health System

Registration Number: NCT03877549

Locations: 🇺🇸
Henry Ford Hospital, Detroit, Michigan, United States

Evaluation of Corticosteroid in Systemic Inflammatory Response Syndrome

Phase 4

Completed

Conditions: Systemic Inflammatory Response Syndrome

Interventions: Drug: solumedrol
Drug: Dexamethasone phosphate

First Posted Date: 2019-03-15

Last Posted Date: 2021-06-14

Lead Sponsor: Assiut University

Target Recruit Count: 60

Registration Number: NCT03876041

Locations: 🇪🇬
Assuit university hospital, Assiut, Assuit, Egypt

Post-operative Analgesic Effects of Dexamethasone Added to Bupivacaine in Transversusabdominis Plane (TAP) Block

Phase 2

Completed

Conditions: Postoperative Analgesia

Interventions: Drug: Dexamethasone
Drug: Bupivacaine

First Posted Date: 2019-03-05

Last Posted Date: 2020-04-28

Lead Sponsor: Assiut University

Target Recruit Count: 90

Registration Number: NCT03863977

Locations: 🇪🇬
Assiut university hospitals, Assiut, Assiut Governorate, Egypt

Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty

Phase 4

Completed

Conditions: Pain, Postoperative
Urethral Stricture

Interventions: Drug: Oxycodone
Drug: Acetaminophen
Drug: Ibuprofen 800 mg
Drug: Gabapentin
Drug: celebrex
Drug: Bupivacaine
Drug: Dexamethasone

First Posted Date: 2019-03-01

Last Posted Date: 2023-08-01

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 60

Registration Number: NCT03859024

Locations: 🇺🇸
University of Alabama of Birmingham, Birmingham, Alabama, United States

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 3

Completed

Conditions: Relapsed or Refractory Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2019-03-01

Last Posted Date: 2024-08-13

Lead Sponsor: Amgen

Target Recruit Count: 454

Registration Number: NCT03859427

Locations: 🇺🇸
Oncology Consultants PA, Houston, Texas, United States
🇳🇱
Gelre Ziekenhuizen, Apeldoorn, Netherlands
🇳🇱
Spaarne Gasthuis, Hoofddorp, Netherlands

and more 105 locations

Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma

Phase 1

Withdrawn

Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
t(11;14) Negative

Interventions: Drug: Dexamethasone
Drug: Ixazomib
Drug: Ixazomib Citrate
Drug: Venetoclax

First Posted Date: 2019-02-27

Last Posted Date: 2019-03-26

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT03856112

IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery

Early Phase 1

Completed

Conditions: Lower Limb Injury

Interventions: Drug: Placebos
Drug: Dexamethasone Sodium Phosphate

First Posted Date: 2019-02-26

Last Posted Date: 2021-07-21

Lead Sponsor: University of Arizona

Target Recruit Count: 50

Registration Number: NCT03855059

Locations: 🇺🇸
Banner University Medical Center, Tucson, Arizona, United States

Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

Phase 3

Terminated

Conditions: Malignant Neoplasm

Interventions: Other: Placebo
Drug: Dexamethasone
Other: Questionnaire
Other: Quality-of-Life Assessment
Drug: Everolimus

First Posted Date: 2019-02-15

Last Posted Date: 2024-11-25

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 39

Registration Number: NCT03839940

Locations: 🇺🇸
Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States
🇺🇸
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
🇺🇸
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States

and more 316 locations

Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Phase 2

Withdrawn

Conditions: Recurrent Plasma Cell Myeloma

Interventions: Biological: Daratumumab
Drug: Dexamethasone
Drug: Pomalidomide

First Posted Date: 2019-02-15

Last Posted Date: 2022-06-15

Lead Sponsor: Academic and Community Cancer Research United

Registration Number: NCT03841565

Locations: 🇺🇸
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸
State University of New York Upstate Medical University, Syracuse, New York, United States

and more 2 locations

DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

Phase 2

Recruiting

Conditions: Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Transformed Lymphoma

Interventions: Drug: Rituximab
Drug: Etoposide
Drug: Vincristine
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Cisplatin
Drug: Cytarabine

First Posted Date: 2019-02-12

Last Posted Date: 2022-01-26

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 118

Registration Number: NCT03837873

Locations: 🇨🇳
the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
🇨🇳
Hunan Cancer Hospital, Changsha, Hunan, China
🇨🇳
the First Affiliated Hospital of Jilin University, Changchun, Jilin, China

and more 3 locations

Drug Development Updates

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