Prednisone: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Prednisone appears in the FDA drug-label database. Marketed as PredniSONE.
- Drug class
- Corticosteroid (FDA established pharmacologic class)
- Mechanism of action
- Corticosteroid Hormone Receptor Agonists (as stated on the FDA label)
FDA-approved use
Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndr…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg — Par Pharmaceutical Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2020-03-04 |
| Labeling: Missing Label; missing label on blister card — Boehringer Ingelheim Roxane Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2013-06-14 |
| Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. — West-Ward Pharmaceutical | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-10-03 |
| Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets — Strides Pharma Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-07-19 |
Phase breakdown
Conditions being studied
Recruiting trials involving Prednisone
- A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
- A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
- A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
- A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
- A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
- A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
- A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
- 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
- Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
- Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
- Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
- Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
- Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
- Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
- Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
- Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
- Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
- REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
- Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
- Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
- Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
- Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
- Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.
- 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)
- Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
- Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
- Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
- The CARDIOPROTECT Trial
Common questions
Is Prednisone FDA-approved?
Yes, marketed as PredniSONE.
How many recruiting trials involve Prednisone?
32 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.