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

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

Phase 1

Completed

Conditions: Neoplasm Malignant

Interventions: Drug: SAR408701
Drug: dexamethasone
Drug: naphazoline
Drug: diphenhydramine

First Posted Date: 2017-10-27

Last Posted Date: 2023-01-09

Lead Sponsor: Sanofi

Target Recruit Count: 34

Registration Number: NCT03324113

Locations: 🇯🇵
Investigational Site Number 3920002, Nagoya-Shi, Japan
🇯🇵
Investigational Site Number 3920003, Kashiwa-Shi, Japan
🇯🇵
Investigational Site Number 3920001, Sunto-Gun, Japan

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Phase 3

Active, not recruiting

Conditions: Plasma Cell Myeloma

Interventions: Drug: Isatuximab SAR650984
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2017-10-24

Last Posted Date: 2024-11-27

Lead Sponsor: Sanofi

Target Recruit Count: 475

Registration Number: NCT03319667

Locations: 🇺🇸
Investigational Site Number: 8400006, Fort Myers, Florida, United States
🇺🇸
Investigational Site Number: 8400004, Saint Petersburg, Florida, United States
🇺🇸
Investigational Site Number: 8400007, Kansas City, Missouri, United States

and more 101 locations

Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

Phase 2

Active, not recruiting

Conditions: Myeloma

Interventions: Drug: Carfilzomib
Drug: Lenalidomide
Device: PET-CT
Drug: Dexamethasone

First Posted Date: 2017-10-19

Last Posted Date: 2023-05-06

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 53

Registration Number: NCT03314636

Locations: 🇸🇪
Skåne University Hospital, Lund, Sweden
🇩🇰
Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
🇩🇰
Odense University Hospital, Odense, Denmark

and more 1 locations

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Dexamethasone
Drug: Daratumumab
Drug: Venetoclax
Drug: Bortezomib

First Posted Date: 2017-10-19

Last Posted Date: 2024-06-17

Lead Sponsor: AbbVie

Target Recruit Count: 156

Registration Number: NCT03314181

Locations: 🇦🇺
Eastern Health /ID# 165850, Box Hill, Victoria, Australia
🇨🇦
Cross Cancer Institute /ID# 203114, Edmonton, Alberta, Canada
🇯🇵
Kameda General Hospital /ID# 225246, Kamogawa-shi, Chiba, Japan

and more 37 locations

Effect of Local Intraoperative Steroid on Dysphagia After ACDF

Phase 3

Completed

Conditions: Dysphagia

Interventions: Drug: Dexamethasone
Drug: Methylprednisolone

First Posted Date: 2017-10-17

Last Posted Date: 2020-11-20

Lead Sponsor: Rush University Medical Center

Target Recruit Count: 140

Registration Number: NCT03311425

Use of Local Intraoperative Steroid in MIS TLIF

Phase 3

Completed

Conditions: Dysphasia

Interventions: Drug: Methylprednisolone
Drug: Dexamethasone

First Posted Date: 2017-10-12

Last Posted Date: 2020-11-20

Lead Sponsor: Rush University Medical Center

Target Recruit Count: 105

Registration Number: NCT03308084

Local Anaesthetic and Steroid in the Ureter

Not Applicable

Conditions: Pain, Postoperative
Ureter Stone

Interventions: Drug: Placebos
Drug: Dexamethasone Sodium Phosphate
Drug: Levobupivacaine

First Posted Date: 2017-09-28

Last Posted Date: 2018-01-17

Lead Sponsor: The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Target Recruit Count: 150

Registration Number: NCT03296189

Locations: 🇮🇪
Adelaide and Meath incorporating National Children's hopsital, Dublin, Ireland

A Novel Analgesia Technique for ACL Reconstruction

Phase 4

Active, not recruiting

Conditions: Anterior Cruciate Ligament Injury

Interventions: Drug: Bupivacaine
Device: Ultrasound
Drug: Dexamethasone

First Posted Date: 2017-09-26

Last Posted Date: 2023-08-30

Lead Sponsor: Hospital for Special Surgery, New York

Target Recruit Count: 78

Registration Number: NCT03292926

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

A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: daratumumab
Drug: carfilzomib
Drug: lenalidomide
Drug: dexamethasone

First Posted Date: 2017-09-25

Last Posted Date: 2024-07-05

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 75

Registration Number: NCT03290950

Locations: 🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

Phase 2

Active, not recruiting

Conditions: Smoldering Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Lenalidomide
Drug: Daratumumab
Drug: Dexamethasone

First Posted Date: 2017-09-20

Last Posted Date: 2023-12-12

Lead Sponsor: International Myeloma Foundation

Target Recruit Count: 87

Registration Number: NCT03289299

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States

and more 7 locations

Drug Development Updates

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