Dexamethasone: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Dexamethasone appears in the FDA drug-label database. Marketed as Dexamethasone.
- Drug class
- Corticosteroid (FDA established pharmacologic class)
- Mechanism of action
- Corticosteroid Hormone Receptor Agonists (as stated on the FDA label)
FDA-approved use
A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of seconda…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). — West-Ward Pharmaceuticals Corp. | Class III (FDA: unlikely to cause harm) | Terminated | 2017-11-06 |
| Labeling: Incorrect or missing package insert. — Sandoz Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2019-10-17 |
| Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. — Eugia US LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-05-23 |
| Temperature Abuse — Sandoz Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-08-13 |
| cGMP deviations: Temperature abuse — Mckesson Medical-Surgical Inc. Corporate Office | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-04-13 |
Phase breakdown
Conditions being studied
Recruiting trials involving Dexamethasone
- A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
- A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
- A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
- A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
- Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
- Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
- FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients
- High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy
- Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery
- Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
- Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors
- PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
- Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
- Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
- Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
- Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
Common questions
Is Dexamethasone FDA-approved?
Yes, marketed as Dexamethasone.
How many recruiting trials involve Dexamethasone?
17 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.