Hydrocortisone: clinical trials recruiting now
3
Recruiting trials
6
Conditions studied
32
US states with sites
46
Countries
FDA drug label
- FDA-approved
- Yes. Hydrocortisone appears in the FDA drug-label database. Marketed as anti itch.
- Drug class
- Corticosteroid (FDA established pharmacologic class)
- Mechanism of action
- Corticosteroid Hormone Receptor Agonists (as stated on the FDA label)
FDA-approved use
Uses • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| Failed Stability Specifications — Perrigo New York | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-05-07 |
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| CGMP Deviations — KENIL HEALTHCARE PRIVATE LIMITED | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2025-04-24 |
| Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. — Taro Pharmaceuticals Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2023-11-06 |
Phase breakdown
Phase 3 2
Phase 4 1
Conditions being studied
| Condition | Trials |
|---|---|
| Prostate cancer | 2 |
| COPD | 1 |
| Chronic Obstructive Pulmonary Disease (COPD) | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Prostate Cancer Metastatic | 1 |
| Prostatic Neoplasms | 1 |
Recruiting trials involving Hydrocortisone
- 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)
- Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Common questions
Is Hydrocortisone FDA-approved?
Yes, marketed as anti itch.
How many recruiting trials involve Hydrocortisone?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.