Everolimus clinical trials
Everolimus is named as an intervention in 53 current clinical trials in our USA, China, France, Spain, South Korea, UK, Italy, Australia, Belgium, Canada, Germany, Netherlands, Taiwan, Japan, Israel, Brazil, Turkey, Mexico, Poland, Austria, Czechia, Denmark, India, Sweden, Norway, Switzerland, Egypt, Ireland and Singapore registers. 27 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Fudan University (3). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 5 authorised or ongoing trials.
Where Everolimus is approved
All regulators →Of the three regulators tracked here, the first to approve Everolimus was the US, on 30 Mar 2009. It is approved in 3 of the 3 regulators tracked here.
- 4 EU orphan designations, most recently for treatment of gastric cancer (30 Aug 2011, withdrawn)
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.
Everolimus patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Everolimus, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 1 Jul 2028 (US 9006224).
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 Everolimus
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 Everolimus works
All drug targets →- FK506-binding protein 1A inhibitor InhibitorTarget: FKBP1A FKBP prolyl isomerase 1AChEMBL only
- Inhibits MTOR Primary targetTarget: MTOR mechanistic target of rapamycin kinaseGuide to Pharmacology only
- Hepatic fibrosisPhase 3
- SeizurePhase 3
- Acute kidney injuryPhase 3
- Autosomal dominant polycystic kidney diseasePhase 3
- Carcinoid tumorPhase 3
- Chronic graft versus host diseasePhase 3
- Chronic kidney diseasePhase 3
- Cirrhosis of liverPhase 3
- Clear cell renal carcinomaPhase 3
- Diabetes mellitusPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1908360, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5889, 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 Everolimus
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Everolimus. 7 are current, and 5 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Immunosuppressive therapy for kidney transplant in adults NICE TA481 | Recommended Not recommended | 11 Oct 2017 | Current |
| Immunosuppressive therapy for kidney transplant in children and young people NICE TA482 | Recommended Not recommended | 11 Oct 2017 | Current |
| Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease NICE TA449 | Recommended | 28 Jun 2017 | Current |
| Everolimus for advanced renal cell carcinoma after previous treatment NICE TA432 | Recommended | 22 Feb 2017 | Current |
| Everolimus with exemestane for treating advanced breast cancer after endocrine therapy NICE TA421 | Recommended | 21 Dec 2016 | Current |
| Everolimus for preventing organ rejection in liver transplantation NICE TA348 | Not recommended | 22 Jul 2015 | Current |
| Everolimus in combination with exemestane for treating advanced HER2-negative hormone-receptor-positive breast cancer after endocrine therapy NICE TA295 | Not recommended | 28 Aug 2013 | 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 Everolimus
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 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 Everolimus
- ChEMBL
- CHEMBL1908360
- DrugBank
- DB01590
- PubChem CID
- 6442177
- CAS number
- 159351-69-6
- FDA UNII
- 9HW64Q8G6G
- Wikidata
- Q421052
- Wikipedia
- Everolimus
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 Everolimus
53 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.
Everolimus in the EU trials register (CTIS)
5 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Everolimus. 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.
Everolimus 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)
8 single-substance products containing Everolimus on the HPRA medicines list.
- Afinitor 10 mg TabletNovartis Europharm Limited · EU/1/09/538/004
- Afinitor 5 mg TabletNovartis Europharm Limited · EU/1/09/538/001
- Votubia 1mg Dispersible tabletNovartis Europharm Limited · EU/1/11/710/016
- Certican 0.25mg TabletsNovartis Ireland Limited · PA0896/005/001 · Not marketed
- Certican 0.75mg TabletsNovartis Ireland Limited · PA0896/005/003 · Not marketed
Supply shortages
- Everolimus TabletUS (FDA) · Resolved · updated 14 Oct 2026
Conditions studied with Everolimus
78 conditionsAll 78 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 9 |
| Metastatic Breast Cancer | 7 |
| Neuroendocrine Tumors | 5 |
| Advanced Breast Cancer | 3 |
| HER2-negative Breast Cancer | 3 |
| ER-positive Breast Cancer | 2 |
| Diffuse Intrinsic Pontine Glioma | 2 |
| Glioblastoma | 2 |
| Renal Cell Carcinoma | 1 |
| Tuberous Sclerosis Complex | 1 |
| Pancreatic Neuroendocrine Tumor (pNET) | 1 |
| Extra-Pancreatic Neuroendocrine Tumor (epNET) | 1 |
| Advanced or Metastatic Breast Cancer | 1 |
| Hormone Receptor-positive Breast Cancer | 1 |
| Hormone Receptor Positive HER-2 Negative Breast Cancer | 1 |
| Carcinoma, Renal Cell | 1 |
| Advanced Solid Tumors | 1 |
| Kirsten Rat Sarcoma (KRAS) pG12C Mutation | 1 |
| Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer | 1 |
| Respiratory Tract Infections | 1 |
| Endometrial Cancer | 1 |
| GEP-NET | 1 |
| Gastroenteropancreatic Neuroendocrine Tumor | 1 |
| Gastroenteropancreatic Neuroendocrine Tumor Disease | 1 |
| Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer | 1 |
| Breast Neoplasms | 1 |
| Breast Cancer Stage I | 1 |
| Breast Cancer Stage II | 1 |
| Locally Advanced Breast Cancer (LABC) | 1 |
| Breast Neoplasm | 1 |
| Hormone Receptor Positive Tumor | 1 |
| Epilepsy | 1 |
| Drug Resistant | 1 |
| Vascular Malformations | 1 |
| HR+/HER2- Advanced Breast Cancer | 1 |
| Targeted Therapy | 1 |
| Locally Advanced or Metastatic Breast Cancer | 1 |
| Locally Advanced Thyroid Gland Carcinoma | 1 |
| Gastroenteropancreatic Neuroendocrine Tumors | 1 |
| Renal Cell Carcinoma (RCC) | 1 |
| Colon Cancer | 1 |
| Locally Advanced Breast Cancer | 1 |
| ESR1 Gene Mutation | 1 |
| High Grade Glioma | 1 |
| Anaplastic Astrocytoma | 1 |
| Liver Allograft | 1 |
| Liver Diseases | 1 |
| Liver Transplantation | 1 |
| Kidney Transplant Failure and Rejection | 1 |
| Primary Non-metastatic Breast Cancer | 1 |
| Who Remain Disease-free | 1 |
| Diffuse Midline Glioma, H3 K27M-Mutant | 1 |
| Diffuse Midline Glioma, H3K27-altered | 1 |
| Meningioma | 1 |
| Pediatric Cancer | 1 |
| Lung Neuroendocrine Neoplasm | 1 |
| Thymus Neoplasms | 1 |
| Malignant Solid Neoplasms | 1 |
| Renal Transplant Recipients | 1 |
| Elderly Patients | 1 |
| Immunosuppression | 1 |
| Postmenopausal Women | 1 |
| Healthy | 1 |
| Osteopenia | 1 |
| Osteoporosis Risk | 1 |
| Metastatic Colorectal Cancer | 1 |
| Recurrent Disease | 1 |
| Recurrent Glioblastoma | 1 |
| Metastatic Digestive System Neuroendocrine Tumor G1 | 1 |
| Metastatic Digestive System Neuroendocrine Tumor G2 | 1 |
| Unresectable Digestive System Neuroendocrine Tumor G1 | 1 |
| Unresectable Digestive System Neuroendocrine Tumor G2 | 1 |
| Progression | 1 |
| Neuroendocrine Tumor Grade 1 | 1 |
| Neuroendocrine Tumor Grade 2 | 1 |
| Heart Transplant | 1 |
| Acute Myeloid Leukemia | 1 |
| Myelodysplastic Syndrome | 1 |
Sponsors
lead sponsor per trial+ 28 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 Everolimus trials
How many clinical trials are testing Everolimus?
53 current trials in our USA, China, France, Spain, South Korea, UK, Italy, Australia, Belgium, Canada, Germany, Netherlands, Taiwan, Japan, Israel, Brazil, Turkey, Mexico, Poland, Austria, Czechia, Denmark, India, Sweden, Norway, Switzerland, Egypt, Ireland and Singapore registers name Everolimus (also registered as RAD001) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Everolimus trials recruiting patients?
Yes. 27 of the 53 trials are recruiting: 4 with sites in USA, 12 with sites in China, 9 with sites in France, 8 with sites in Spain, 3 with sites in South Korea, 3 with sites in UK, 5 with sites in Italy, 4 with sites in Australia, 4 with sites in Belgium, 4 with sites in Canada, 5 with sites in Germany, 3 with sites in Netherlands, 2 with sites in Taiwan, 1 with sites in Japan, 2 with sites in Israel, 4 with sites in Brazil, 1 with sites in Turkey, 3 with sites in Mexico, 2 with sites in Poland, 2 with sites in Austria, 2 with sites in Czechia, 3 with sites in Denmark, 1 with sites in India, 2 with sites in Sweden, 2 with sites in Norway and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Everolimus clinical trials?
Fudan University (3), ITM Solucin GmbH (2), Pfizer (2) and Merck Sharp & Dohme LLC (2), among 43 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Everolimus clinical trials in Ireland?
Yes. 1 trial 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 Everolimus licensed in Ireland?
Yes. The HPRA medicines list includes 8 single-substance products containing Everolimus, for example Afinitor 10 mg Tablet (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Everolimus shortage?
The registers we track list 1 entry for Everolimus: US FDA: resolved. 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 Everolimus 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 Everolimus 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 Everolimus (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.