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

Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia (ALL)
Ph-positive Adult Acute Lymphoblastic Leukemia (ALL)
B-cell Adult Acute Lymphoblastic Leukemia (ALL)
T-cell Adult Acute Lymphoblastic Leukemia (ALL)

Interventions: Drug: Bortezomib
Drug: Doxorubicin hydrochloride (HCl)
Drug: PEG-Asparaginase
Drug: Vincristine sulfate
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate

First Posted Date: 2013-01-16

Last Posted Date: 2018-11-14

Lead Sponsor: Stanford University

Target Recruit Count: 18

Registration Number: NCT01769209

Locations: 🇺🇸
Stanford University, School of Medicine, Stanford, California, United States

Dexamethasone and Lower Extremity Block Duration

Phase 4

Terminated

Conditions: Analgesia Duration

Interventions: Drug: Dexamethasone
Drug: Bupivacaine

First Posted Date: 2012-12-27

Last Posted Date: 2017-06-27

Lead Sponsor: University of Chicago

Target Recruit Count: 4

Registration Number: NCT01756586

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

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2012-12-21

Last Posted Date: 2024-02-20

Lead Sponsor: Cristina Gasparetto

Target Recruit Count: 56

Registration Number: NCT01754402

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

Phase 1

Completed

Conditions: Plasma Cell Myeloma

Interventions: Drug: isatuximab SAR650984
Drug: lenalidomide
Drug: dexamethasone

First Posted Date: 2012-12-17

Last Posted Date: 2023-07-13

Lead Sponsor: Sanofi

Target Recruit Count: 57

Registration Number: NCT01749969

Locations: 🇺🇸
Investigational Site Number 840004, San Francisco, California, United States
🇺🇸
Investigational Site Number 840003, Columbus, Ohio, United States
🇺🇸
Investigational Site Number 840001, Tampa, Florida, United States

and more 2 locations

Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer

Not Applicable

Completed

Conditions: Dysphagia
Pain
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma

Interventions: Drug: Dexamethasone
Procedure: Quality-of-Life Assessment
Other: Placebo
Other: Questionnaire Administration
Procedure: Transoral Robotic Surgery

First Posted Date: 2012-12-13

Last Posted Date: 2018-06-19

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 76

Registration Number: NCT01748942

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

Phase 3

Completed

Conditions: Diabetic Macular Edema

Interventions: Drug: dexamethasone intravitreal implant (OZURDEX)

First Posted Date: 2012-12-12

Last Posted Date: 2015-12-02

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 24

Registration Number: NCT01748487

Locations: 🇨🇦
UHN, Toronto Western Hospital, Toronto, Ontario, Canada

Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14)

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: POMALIDOMIDE
Drug: Dexamethasone

First Posted Date: 2012-12-10

Last Posted Date: 2015-12-04

Lead Sponsor: University Hospital, Lille

Target Recruit Count: 63

Registration Number: NCT01745640

Locations: 🇫🇷
CHRU-Hôpital Sud Amiens, Amiens, France
🇫🇷
Hôpital Haut-Leveque, PESSAC cedex, France
🇫🇷
Chru Lille, Lille, France

and more 17 locations

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Pomalidomide
Procedure: stem cell
Drug: Dexamethasone
Drug: Clarithromycin

First Posted Date: 2012-12-10

Last Posted Date: 2024-07-03

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 23

Registration Number: NCT01745588

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
North Shore LIJ, New Hyde Park, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

and more 6 locations

Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

Phase 4

Terminated

Conditions: Community-acquired Pneumonia

Interventions: Drug: Dexamethasone
Drug: Placebo

First Posted Date: 2012-12-06

Last Posted Date: 2019-04-18

Lead Sponsor: St. Antonius Hospital

Target Recruit Count: 413

Registration Number: NCT01743755

Locations: 🇳🇱
St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands
🇳🇱
OLVG, Amsterdam, Noord-Holland, Netherlands
🇳🇱
Canisius Wilhelmina Hospital, Nijmegen, Gelderland, Netherlands

and more 1 locations

Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis

Not Applicable

Completed

Conditions: Postoperative Vomiting

Interventions: Drug: Dexamethasone + ondansetron + Droperidol
Drug: Dexamethasone + ondansetron + Placebo

First Posted Date: 2012-12-04

Last Posted Date: 2014-07-28

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 322

Registration Number: NCT01739985

Locations: 🇫🇷
Necker Hospital, Paris, France

Drug Development Updates

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