Hydrocortisone clinical trials
Hydrocortisone is named as an intervention in 22 current clinical trials in our Canada, Australia, Israel, France, Denmark, Sweden, Mexico, Taiwan, China, Germany, Italy, Czechia, Japan, South Korea, Singapore, Ireland, UK, USA, Spain, Netherlands, Austria, Turkey, Brazil, Switzerland, Poland, Norway, Portugal, Belgium and Egypt registers. 16 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Merck Sharp & Dohme LLC (2). The most-studied condition is Acute Lymphoblastic Leukemia. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Hydrocortisone is approved
All regulators →Of the three regulators tracked here, the first to approve Hydrocortisone was the US, on 21 Dec 1951. It is approved in 2 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of adrenal insufficiency (20 Mar 2007, withdrawn)
- 1 EU safety letter (DHPC), latest: safety signal for Alkindi, 4 Feb 2021
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Hydrocortisone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Hydrocortisone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 23 Feb 2043 (US 12133914).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Hydrocortisone
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Hydrocortisone works
All drug targets →- Glucocorticoid receptor agonist AgonistTarget: NR3C1 nuclear receptor subfamily 3 group C member 1✓ In ChEMBL and the Guide to Pharmacology
- Ulcerative colitisPhase 3
- HemorrhoidPhase 2
- Thickened skinPhase 1
- Atopic eczemaPhase 1
- Major depressive disorderEarly phase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1091, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2868, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Hydrocortisone
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Hydrocortisone. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Frequency of application of topical corticosteroids for atopic eczema NICE TA81 | Recommended | 25 Aug 2004 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Hydrocortisone
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 23 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Hydrocortisone
- ChEMBL
- CHEMBL1091
- DrugBank
- DB14539
- PubChem CID
- 5744
- CAS number
- 50-03-3
- FDA UNII
- 3X7931PO74
- Wikidata
- Q27102474
- Wikipedia
- Hydrocortisone acetate
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Hydrocortisone
22 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Hydrocortisone in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Hydrocortisone. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Hydrocortisone across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
23 single-substance products containing Hydrocortisone on the HPRA medicines list.
- Cortopin 1% w/w CreamPinewood Laboratories Ltd · PA0281/071/002 · Marketed
- HC45 Hydrocortisone Acetate Cream (Hydrocortisone Acetate 1% w/w)Karo Pharma AB · PA22650/008/001 · Marketed
- Hydrocortisone 1% w/w CreamOvelle Limited · PA0206/030/001 · Marketed
- Hydrocortisone 10 mg TabletsRenata Pharmaceuticals (Ireland) Limited · PA22865/003/001 · Marketed
- Hydrocortisone 5 mg TabletsRenata Pharmaceuticals (Ireland) Limited · PA22865/003/003 · Marketed
Supply shortages
No entry for Hydrocortisone in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Hydrocortisone
42 conditionsAll 42 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Lymphoblastic Leukemia | 3 |
| Adrenal Insufficiency | 2 |
| Prostate Cancer Metastatic | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Prostatic Neoplasms | 1 |
| Septic Shock | 1 |
| B Acute Lymphoblastic Leukemia | 1 |
| Mixed Phenotype Acute Leukemia | 1 |
| T Acute Lymphoblastic Leukemia | 1 |
| Sepsis | 1 |
| Ocular Inflammation | 1 |
| Ocular Prostheses | 1 |
| Inflammation in Cardiac Surgery | 1 |
| Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial | 1 |
| Polymyalgia Rheumatica | 1 |
| Giant Cell Arteritis | 1 |
| Polymyalgia Rheumatica (PMR) | 1 |
| Giant Cell Arteritis (GCA) | 1 |
| Community Acquired Pneumonia (CAP) | 1 |
| Chronic Obstructive Pulmonary Disease (COPD) | 1 |
| Mild Autonomous Cortisol Secretion (MACS) | 1 |
| Diabetes Mellitus (Type 2) | 1 |
| Recurrent B Acute Lymphoblastic Leukemia | 1 |
| Acute Lymphoblastic Leukemia, Pediatric | 1 |
| CNS Embryonal Tumor | 1 |
| CNS, Medulloblastoma | 1 |
| Atypical Teratoid Rhabdoid Tumor | 1 |
| Medulloblastoma, Childhood | 1 |
| Acute Myeloid Leukemia | 1 |
| Down Syndrome | 1 |
| Childhood Cancer | 1 |
| Leukemia, Lymphoblastic, Acute, Philadelphia-Positive | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | 1 |
| Hematologic Malignancy | 1 |
| AML | 1 |
| ALL | 1 |
| BPDCN | 1 |
| Pancreatitis | 1 |
| Pancreatitis, Acute | 1 |
| Corticosteroid | 1 |
| Hydrocortisone | 1 |
| Post Spinal Anaesthesia Hypotension | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Merck Sharp & Dohme LLC | 2 |
| Children's Oncology Group | 2 |
| Copenhagen Respiratory Research | 2 |
| Northern Jiangsu People's Hospital | 1 |
| Assistance Publique - Hôpitaux de Paris | 1 |
| Agnes | 1 |
| Centre Hospitalier Universitaire, Amiens | 1 |
| Tiohundra AB | 1 |
| Marianne Christina Klose | 1 |
| Marianne Andersen | 1 |
| Beckey Trinh | 1 |
| National Cancer Institute (NCI) | 1 |
| Dana-Farber Cancer Institute | 1 |
| C17 Council | 1 |
| National Hospital Organization Nagoya Medical Center | 1 |
+ 4 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Hydrocortisone trials
How many clinical trials are testing Hydrocortisone?
22 current trials in our Canada, Australia, Israel, France, Denmark, Sweden, Mexico, Taiwan, China, Germany, Italy, Czechia, Japan, South Korea, Singapore, Ireland, UK, USA, Spain, Netherlands, Austria, Turkey, Brazil, Switzerland, Poland, Norway, Portugal, Belgium and Egypt registers name Hydrocortisone as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Hydrocortisone trials recruiting patients?
Yes. 16 of the 22 trials are recruiting: 4 with sites in Canada, 5 with sites in Australia, 5 with sites in Israel, 5 with sites in France, 5 with sites in Denmark, 3 with sites in Sweden, 3 with sites in Mexico, 3 with sites in Taiwan, 3 with sites in China, 2 with sites in Germany, 2 with sites in Italy, 2 with sites in Czechia, 2 with sites in Japan, 3 with sites in South Korea, 2 with sites in Singapore, 2 with sites in Ireland, 2 with sites in UK, 2 with sites in USA, 2 with sites in Spain, 1 with sites in Netherlands, 1 with sites in Austria, 2 with sites in Turkey, 2 with sites in Brazil, 1 with sites in Poland, 1 with sites in Norway and 1 with sites in Portugal. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Hydrocortisone clinical trials?
Merck Sharp & Dohme LLC (2), Children's Oncology Group (2), Copenhagen Respiratory Research (2) and Northern Jiangsu People's Hospital (1), among 19 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Hydrocortisone clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Hydrocortisone licensed in Ireland?
Yes. The HPRA medicines list includes 23 single-substance products containing Hydrocortisone, for example Cortopin 1% w/w Cream (Pinewood Laboratories Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Hydrocortisone shortage?
Not in the lists we track: Hydrocortisone has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Hydrocortisone works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Hydrocortisone works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Hydrocortisone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.