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

The Danish Out-of-Hospital Cardiac Arrest Study

Phase 3

Recruiting

Conditions: Out-Of-Hospital Cardiac Arrest
Post-Cardiac Arrest Syndrome

Interventions: Procedure: Backrest elevation
Procedure: Early wakeup call
Drug: Dexamethasone
Drug: Olanzapine

First Posted Date: 2023-06-09

Last Posted Date: 2023-09-21

Lead Sponsor: Christian Hassager

Target Recruit Count: 1000

Registration Number: NCT05895838

Locations: 🇩🇰
The Department of Intensive Care, Aalborg University Hospital, Aalborg, Aalborg, Denmark
🇩🇰
Dept. of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Capital Region Of Denmark, Denmark
🇩🇰
The Department of Intensive Care, Aarhus University Hospital, Aarhus, Aarhus, Denmark

and more 2 locations

Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone

Phase 3

Recruiting

Conditions: Pediatric Cancer

Interventions: Drug: Ondansetron
Drug: Dexamethasone

First Posted Date: 2023-05-24

Last Posted Date: 2023-07-21

Lead Sponsor: Immune Oncology Research Institute

Target Recruit Count: 40

Registration Number: NCT05872893

Locations: 🇦🇲
Hematology Center named after prof. R. Yeolyan, Yerevan, Armenia

Immune Thrombocytopenia Management in Adults

Phase 4

Recruiting

Conditions: Immune Thrombocytopenia Purpura

Interventions: Drug: Dexamethasone
Drug: Prednisolone and Azathioprine
Drug: Rituximab
Drug: Eltrombopag
Drug: Romiplostim

First Posted Date: 2023-05-16

Last Posted Date: 2023-05-16

Lead Sponsor: Nahda University

Target Recruit Count: 467

Registration Number: NCT05861297

Locations: 🇪🇬
EL-Kasr elineiy, Cairo, Egypt

EFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD

Not Applicable

Conditions: Asthma in Children

Interventions: Drug: Dexamethasone
Drug: Prednisolone

First Posted Date: 2023-05-09

Last Posted Date: 2023-05-09

Lead Sponsor: DR. MOHAMMAD ALI ARIF

Target Recruit Count: 192

Registration Number: NCT05850143

Locations: 🇵🇰
Asim Nawaz Niazi, Islamabad, Pakistan

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Phase 1

Recruiting

Conditions: Lymphoblastic Leukemia

Interventions: Drug: Dexamethasone
Drug: Mitoxantrone
Drug: PEG asparaginase
Drug: Bortezomib
Drug: Vorinostat
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Blinatumomab
Drug: Ziftomenib

First Posted Date: 2023-05-08

Last Posted Date: 2024-11-25

Lead Sponsor: Tanja Andrea Gruber

Target Recruit Count: 90

Registration Number: NCT05848687

Locations: 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States

and more 22 locations

Antenatal Dexamethasone for Late Preterm Deliveries

Phase 1

Recruiting

Conditions: Preterm Birth
Respiratory Distress of Newborn

Interventions: Drug: Dexamethasone

First Posted Date: 2023-05-03

Last Posted Date: 2024-02-08

Lead Sponsor: Chulalongkorn University

Target Recruit Count: 294

Registration Number: NCT05841121

Locations: 🇻🇳
Danang HOspital for Women and Children, Da Nang, Vietnam

Selinexor and Lenalidomide for Consolidation and Maintenance Treatment in Multiple Myeloma Post-transplant

Phase 2

Withdrawn

Conditions: Multiple Myeloma
Myeloma-Associated Amyloidosis

Interventions: Drug: Selinexor
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2023-04-20

Last Posted Date: 2024-07-10

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT05820763

Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.

Not Applicable

Recruiting

Conditions: Angioimmunoblastic T-cell Lymphoma
Peripheral T-Cell Lymphoma, Not Otherwise Specified

Interventions: Drug: Rituximab
Drug: Gemcitabine
Drug: Dexamethasone
Drug: Cisplatin
Drug: PD-1 monoclonal antibody

First Posted Date: 2023-04-20

Last Posted Date: 2023-04-20

Lead Sponsor: Ou Bai, MD/PHD

Target Recruit Count: 34

Registration Number: NCT05821192

Locations: 🇨🇳
The First Bethune Hospital of Jilin University, Changchun, Jilin, China

Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure (STERO-AHF)

Phase 2

Recruiting

Conditions: Acute Heart Failure

Interventions: Drug: Dexamethasone
Drug: Prednisone

First Posted Date: 2023-04-12

Last Posted Date: 2023-12-04

Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Target Recruit Count: 120

Registration Number: NCT05809011

Locations: 🇮🇹
ASST Spedali Civili di Brescia, Brescia, Italy

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

Phase 3

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Isatuximab
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2023-04-07

Last Posted Date: 2024-05-29

Lead Sponsor: University of Heidelberg Medical Center

Target Recruit Count: 514

Registration Number: NCT05804032

Locations: 🇦🇹
Phyrn-Eisenwurzen Klinikum Steyr, Steyr, Austria
🇦🇹
Universitätsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz, Salzburg, Austria
🇩🇪
Charité, III. Medizinische Abteilung (Hämatologie/Onkologie), Berlin, Germany

and more 78 locations

Drug Development Updates

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