Spironolactone clinical trials
Spironolactone is named as an intervention in 17 current clinical trials in our China, France, Netherlands, India, Germany, Sweden, Mexico, Denmark, Canada, Brazil and Egypt registers. 12 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Second Affiliated Hospital of Nanchang University (2). The most-studied condition is Primary Aldosteronism. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Spironolactone is approved
All regulators →Of the three regulators tracked here, the first to approve Spironolactone was the US, on 21 Jan 1960. It is approved in 2 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of limbal stem cell deficiency (23 Feb 2026, positive)
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.
Spironolactone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Spironolactone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 8 listed patents; the last listed expires 28 Oct 2036 (US 9757394).
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 Spironolactone
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 Spironolactone works
All drug targets →- Mineralocorticoid receptor antagonist AntagonistTarget: NR3C2 nuclear receptor subfamily 3 group C member 2✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Duchenne muscular dystrophyPhase 3
- Hypertension resistant to conventional therapyPhase 3
- Myocardial fibrosisPhase 3
- Peritoneal FibrosisPhase 3
- Abnormal glucose tolerancePhase 3
- AcnePhase 3
- Acute respiratory distress syndromePhase 3
- Atrial fibrillationPhase 3
- Autosomal dominant polycystic kidney diseasePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1393, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2875, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Spironolactone
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 11 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: QaialdoEMA product information: package leaflet and summary of product characteristics in every EU language.
- 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 Spironolactone
- ATC code
- C03DA01
- ChEMBL
- CHEMBL1393
- DrugBank
- DB00421
- PubChem CID
- 5833
- CAS number
- 52-01-7
- FDA UNII
- 27O7W4T232
- Wikidata
- Q422188
- Wikipedia
- Spironolactone
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 Spironolactone
17 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.
Spironolactone in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Spironolactone. 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.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
AFTER - Treatment of women with Acne vulgaris - Evaluation of the eFficacy of isoTretinoin low-dose vs spironolactonE in the attack phase and spiRonolactone in the maintenance phase:
A 2-step randomized controlled trial
2025-520773-39-00 · CTIS ↗ · Skin and Connective Tissue Diseases
|
Phase 3 | Authorised | Assistance Publique Hopitaux De Paris | France |
|
Withdrawal of neurohormonal therapy in patients with non-ischemic cardiomyopathy, no late gadolinium enhancement, and negative genetic testing, who have exhibited super-response to cardiac resynchronization therapy. DRUGLESS-CRT clinical trial.
2025-521780-12-00 · CTIS ↗ · Cardiovascular Diseases
|
Phase 3 | Ongoing | Andrea Di Marco | Spain |
Spironolactone 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)
11 single-substance products containing Spironolactone on the HPRA medicines list.
- Aldactone 100 mg Film-coated tabletsPfizer Healthcare Ireland Unlimited Company · PA0822/110/003 · Marketed
- Aldactone 25 mg Film-coated TabletsPfizer Healthcare Ireland Unlimited Company · PA0822/110/001 · Marketed
- Aldactone 50 mg Film-coated tabletsPfizer Healthcare Ireland Unlimited Company · PA0822/110/002 · Marketed
- Spironolactone 100 mg film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/119/003 · Marketed
- Spironolactone 25 mg film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/119/001 · Marketed
Supply shortages
- Spironolactone TabletUS (FDA) · Resolved · updated 10 Dec 2025
- Spironolacton Accord 50 mg FilmtablettenGermany (BfArM) · Production problem · 20 Oct 2026 to 31 Dec 2026
Conditions studied with Spironolactone
22 conditionsAll 22 conditions
| Condition (as registered) | Trials |
|---|---|
| Primary Aldosteronism | 4 |
| Chronic Kidney Diseases | 2 |
| Hypertension | 2 |
| MASLD | 1 |
| NCOR Gene Mutations | 1 |
| Spironolactone | 1 |
| ASD | 1 |
| Idiopathic Hyperaldosteronism | 1 |
| Hyperaldosteronism | 1 |
| Alport Syndrome | 1 |
| Hereditary Kidney Disease | 1 |
| Pediatric Kidney Disease | 1 |
| Thin Basement Membrane Disease | 1 |
| Rheumatoid Arthritis | 1 |
| Arrhythmogenic Right Ventricular Dysplasia | 1 |
| CKD | 1 |
| Cardiovascular Diseases | 1 |
| Heart Failure | 1 |
| Heart Failure With Preserved Ejection Fraction | 1 |
| Systolic Heart Failure | 1 |
| HIV | 1 |
| Acne Vulgaris | 1 |
Sponsors
lead sponsor per trialBy 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 Spironolactone trials
How many clinical trials are testing Spironolactone?
17 current trials in our China, France, Netherlands, India, Germany, Sweden, Mexico, Denmark, Canada, Brazil and Egypt registers name Spironolactone as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Spironolactone trials recruiting patients?
Yes. 12 of the 17 trials are recruiting: 6 with sites in China, 2 with sites in France, 2 with sites in Netherlands, 1 with sites in Germany, 1 with sites in Sweden and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Spironolactone clinical trials?
Second Affiliated Hospital of Nanchang University (2), Third Military Medical University (2), Institute of Liver and Biliary Sciences, India (1) and Qilu Hospital of Shandong University (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Spironolactone licensed in Ireland?
Yes. The HPRA medicines list includes 11 single-substance products containing Spironolactone, for example Aldactone 100 mg Film-coated tablets (Pfizer Healthcare Ireland Unlimited Company). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Spironolactone shortage?
The registers we track list 2 entries for Spironolactone: US FDA: resolved; 1 German notice. Shortages are product- and country-specific; check with a pharmacist.
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 Spironolactone 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 Spironolactone 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 Spironolactone (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.