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

Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: bortezomib
Drug: dexamethasone

First Posted Date: 2007-04-11

Last Posted Date: 2016-08-10

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 40

Registration Number: NCT00458822

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Second Line Therapy to Treat Age-related Macular Degeneration (AMD) for Patients Not Responding Well to Lucentis Therapy by Itself

Phase 2

Withdrawn

Conditions: Age Related Macular Degeneration

First Posted Date: 2007-04-06

Last Posted Date: 2017-08-23

Lead Sponsor: Vitreous -Retina- Macula Consultants of New York

Registration Number: NCT00457678

Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Thalidomide
Drug: Dexamethasone

First Posted Date: 2007-03-27

Last Posted Date: 2019-11-18

Lead Sponsor: Celgene

Target Recruit Count: 499

Registration Number: NCT00452569

Locations: 🇵🇱
Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej, Wroclaw, Poland
🇮🇳
Department of Medical Oncology/Regional Cancer Centre, Trivandrum, India
🇮🇳
Department of Medical Oncology, Deenanath Mangeshkar Hospital, Pune, India

and more 82 locations

Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults

Phase 2

Conditions: Airway Obstruction

First Posted Date: 2007-03-26

Last Posted Date: 2007-03-26

Lead Sponsor: Mackay Memorial Hospital

Target Recruit Count: 70

Registration Number: NCT00452062

Locations: 🇨🇳
Mackay Memorial Hospital, Taipei, Taiwan

High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

Phase 3

Completed

Conditions: Idiopathic Thrombocytopenic Purpura

First Posted Date: 2007-03-23

Last Posted Date: 2011-01-13

Lead Sponsor: Cooperative Study Group A for Hematology

Target Recruit Count: 157

Registration Number: NCT00451594

Locations: 🇰🇷
Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of

R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Drug: Rituximab
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Doxorubicin
Drug: Etoposide
Drug: Ifosfamide
Drug: Leucovorin
Drug: Methotrexate
Drug: Thalidomide
Drug: Vincristine
Drug: Mesna
Drug: Filgrastim (G-CSF)
Drug: Granisetron
Drug: Decadron

First Posted Date: 2007-03-22

Last Posted Date: 2015-11-10

Lead Sponsor: University of Miami

Target Recruit Count: 22

Registration Number: NCT00450801

Locations: 🇺🇸
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma

Phase 2

Completed

Conditions: DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: Clarithromycin
Drug: Dexamethasone
Drug: Lenalidomide

First Posted Date: 2007-03-09

Last Posted Date: 2019-11-13

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 32

Registration Number: NCT00445692

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: adriamycin
Drug: dexamethasone
Drug: bortezomib
Drug: vincristine

First Posted Date: 2007-02-28

Last Posted Date: 2014-03-21

Lead Sponsor: Janssen-Cilag International NV

Target Recruit Count: 30

Registration Number: NCT00441168

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

Phase 1

Completed

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Doxorubicin
Drug: Cytarabine
Drug: Methotrexate
Drug: Vincristine
Drug: Triple IT Therapy

First Posted Date: 2007-02-27

Last Posted Date: 2020-02-19

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 31

Registration Number: NCT00440726

Locations: 🇨🇦
Sick Kids, Toronto, Ontario, Canada
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 21 locations

ABT-751 With Chemotherapy for Relapsed Pediatric ALL

Phase 1

Terminated

Conditions: Recurrent Pediatric ALL
Acute Lymphoblastic Leukemia
Refractory Pediatric ALL
Relapsed Pediatric ALL

Interventions: Drug: ABT-751
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Doxorubicin
Drug: Cytarabine
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: 6-thioguanine

First Posted Date: 2007-02-23

Last Posted Date: 2021-03-17

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 9

Registration Number: NCT00439296

Locations: 🇺🇸
Stanford University Medical Center, Palo Alto, California, United States
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States

and more 2 locations

Drug Development Updates

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