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 of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 1

Completed

Conditions: Acute Lymphoblastic Leukemia (ALL)

Interventions: Drug: Carfilzomib
Drug: Dexamethasone
Drug: Mitoxantrone
Drug: PEG-asparaginase
Drug: Vincristine
Drug: Intrathecal (IT) Methotrexate
Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
Drug: 6-Mercaptopurine
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin

First Posted Date: 2014-12-01

Last Posted Date: 2024-07-16

Lead Sponsor: Amgen

Target Recruit Count: 130

Registration Number: NCT02303821

Locations: 🇺🇸
Childrens Healthcare of Atlanta, Egleston, Atlanta, Georgia, United States
🇺🇸
West Virginia University Medicine Childrens, Morgantown, West Virginia, United States
🇹🇷
Medical Park Bahcelievler Hastanesi, Istanbul, Turkey

and more 116 locations

Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Not Applicable

Conditions: Cervical Radiculopathy

Interventions: Procedure: SNR steroid (dexamethasone) injection
Procedure: CTF steroid (dexamethasone) injection
Drug: Dexamethasone
Device: Ultrasound
Radiation: C arm

First Posted Date: 2014-11-20

Last Posted Date: 2014-11-21

Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Target Recruit Count: 60

Registration Number: NCT02295709

Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Dexamethasone
Drug: Prednisone
Drug: Methylprednisolone
Drug: Lenalidomide
Drug: Pomalidomide

First Posted Date: 2014-11-19

Last Posted Date: 2023-11-01

Lead Sponsor: Oncotherapeutics

Target Recruit Count: 45

Registration Number: NCT02294357

Locations: 🇺🇸
James R Berenson, MD, Inc., West Hollywood, California, United States
🇺🇸
Blood & Cancer Center of East Texas, Tyler, Texas, United States
🇺🇸
California Cancer Associates for Research & Excellence (cCARE), Encinitas, California, United States

and more 4 locations

Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma

Phase 1

Completed

Conditions: Contiguous Stage II Adult Lymphoblastic Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia

Interventions: Drug: carfilzomib
Drug: cyclophosphamide
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: dexamethasone
Drug: methotrexate
Drug: cytarabine
Drug: leucovorin calcium
Drug: methylprednisolone
Biological: rituximab
Other: laboratory biomarker analysis

First Posted Date: 2014-11-18

Last Posted Date: 2022-03-10

Lead Sponsor: Mehrdad Abedi, MD

Target Recruit Count: 10

Registration Number: NCT02293109

Locations: 🇺🇸
University of California Davis, Sacramento, California, United States

The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Phase 4

Completed

Conditions: Osteoarthritis

Interventions: Drug: Bupivacaine
Drug: Morphine
Drug: Methylprednisolone
Drug: Cefazolin
Drug: Normal saline
Drug: Midazolam
Drug: Propofol
Drug: Dexamethasone
Device: 8 MHz. Chiba needle, 22 G / 4 inches

First Posted Date: 2014-11-17

Last Posted Date: 2019-01-11

Lead Sponsor: Hospital for Special Surgery, New York

Target Recruit Count: 111

Registration Number: NCT02292082

Locations: 🇺🇸
Hospital for Special Surgery, New York, New York, United States

Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma

Phase 2

Completed

Conditions: Relapse/Refractory Multiple Myeloma

Interventions: Drug: LBH589 (panobinostat)
Drug: bortezomib
Drug: dexamethasone

First Posted Date: 2014-11-14

Last Posted Date: 2019-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 31

Registration Number: NCT02290431

Locations: 🇯🇵
Novartis Investigative Site, Tokushima, Japan

1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: MK-3475
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2014-11-13

Last Posted Date: 2019-11-05

Lead Sponsor: Ashraf Badros

Target Recruit Count: 48

Registration Number: NCT02289222

Locations: 🇺🇸
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States

Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

Phase 2

Conditions: Rectal Cancer

Interventions: Other: General condition
Other: Blood pressure
Other: Patient Reported Outcome
Other: Clinical findings
Other: Hematology/blood chemistry
Other: Coagulation and fibrinolysis system
Other: Urinalysis
Other: Medication check
Other: Adverse event
Other: Thyroid function test
Other: Contrast-enhanced torso CT
Other: Brain MRI
Drug: Dexamethasone
Drug: Placebo
Drug: Regorafenib
Drug: Proton pump inhibitor

First Posted Date: 2014-11-11

Last Posted Date: 2014-11-13

Lead Sponsor: Clinical Research Support Center Kyush

Target Recruit Count: 74

Registration Number: NCT02288078

Locations: 🇯🇵
Saiseikai Fukuoka General Hospital, Fukuoka, Japan

SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

Phase 1

Completed

Conditions: Plasma Cell Myeloma

Interventions: Drug: Isatuximab SAR650984
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2014-11-05

Last Posted Date: 2021-07-09

Lead Sponsor: Sanofi

Target Recruit Count: 54

Registration Number: NCT02283775

Locations: 🇺🇸
Investigational Site Number 840011, Decatur, Illinois, United States
🇺🇸
Investigational Site Number 840015, Salt Lake City, Utah, United States
🇺🇸
Investigational Site Number 840005, Seattle, Washington, United States

and more 10 locations

E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Phase 2

Completed

Conditions: Smoldering Myeloma
Smoldering Multiple Myeloma

Interventions: Drug: Elotuzumab
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2014-10-31

Last Posted Date: 2023-06-09

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 51

Registration Number: NCT02279394

Locations: 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 6 locations

Drug Development Updates

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