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 Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab IV
Drug: Lenalidomide
Drug: Daratumumab SC
Drug: Dexamethasone

First Posted Date: 2014-09-30

Last Posted Date: 2024-12-20

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 737

Registration Number: NCT02252172

Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma

Phase 3

Conditions: Multiple Myeloma

Interventions: Drug: Clarithromycin
Drug: Thalidomide
Drug: Cyclophosphamide
Drug: Dexamethasone

First Posted Date: 2014-09-25

Last Posted Date: 2017-09-06

Lead Sponsor: Jinling Hospital, China

Target Recruit Count: 130

Registration Number: NCT02248428

Locations: 🇨🇳
Jinling Hospital, Nanjing, Jiangsu, China

Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture

Phase 4

Terminated

Conditions: Hip Fracture

Interventions: Drug: Saline
Drug: Dexamethasone

First Posted Date: 2014-09-25

Last Posted Date: 2015-09-14

Lead Sponsor: University of Aarhus

Target Recruit Count: 7

Registration Number: NCT02248870

Locations: 🇩🇰
Aarhus University Hospital, Aarhus, Denmark

A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome (MDS)

Phase 1

Terminated

Conditions: Myelodysplastic Syndromes

Interventions: Drug: cenersen
Drug: Dexamethasone

First Posted Date: 2014-09-17

Last Posted Date: 2021-02-21

Lead Sponsor: Eleos, Inc.

Target Recruit Count: 9

Registration Number: NCT02243124

Locations: 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.

Phase 4

Recruiting

Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease

Interventions: Drug: Dexamethasone
Drug: Prednisone

First Posted Date: 2014-09-11

Last Posted Date: 2023-04-06

Lead Sponsor: Rabin Medical Center

Target Recruit Count: 80

Registration Number: NCT02237820

Locations: 🇮🇱
Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel

Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Dexamethasone

First Posted Date: 2014-09-10

Last Posted Date: 2014-09-10

Lead Sponsor: Hvidovre University Hospital

Target Recruit Count: 19

Registration Number: NCT02235584

Locations: 🇩🇰
Bispebjerg University Hospital, Copenhagen NV, Denmark

The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage

Completed

Conditions: Tonsillectomy
Adenotonsillectomy

Interventions: Drug: Dexamethasone

First Posted Date: 2014-08-28

Last Posted Date: 2017-07-26

Lead Sponsor: Nicole Elsey

Target Recruit Count: 9843

Registration Number: NCT02228135

Locations: 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States

Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy

Not Applicable

Terminated

Conditions: Gallbladder Polyp
Asymptomatic Gallstones Without Cholecystitis

Interventions: Drug: Lidocaine
Drug: Dexamethasone

First Posted Date: 2014-08-25

Last Posted Date: 2019-03-19

Lead Sponsor: Yonsei University

Target Recruit Count: 8

Registration Number: NCT02224170

Locations: 🇰🇷
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea, Seoul, Korea, Republic of

Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Completed

Conditions: Stage II Multiple Myeloma
Stage I Multiple Myeloma
Stage III Multiple Myeloma

Interventions: Drug: Bendamustine hydrochloride
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2014-08-25

Last Posted Date: 2019-09-13

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 24

Registration Number: NCT02224729

Locations: 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies

Phase 1

Terminated

Conditions: Lymphoid Hematological Malignancies
Relapsed and Refractory Multiple Myeloma

Interventions: Drug: CB-5083
Drug: Dexamethasone

First Posted Date: 2014-08-22

Last Posted Date: 2018-02-27

Lead Sponsor: Cleave Biosciences, Inc.

Target Recruit Count: 120

Registration Number: NCT02223598

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
RCCA MD, Bethesda, Maryland, United States

and more 5 locations

Drug Development Updates

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