Tacrolimus clinical trials
Tacrolimus is named as an intervention in 47 current clinical trials in our China, USA, Canada, Spain, Germany, Brazil, France, Italy, Australia, UK, Netherlands, Sweden, Egypt, Czechia, Japan, South Korea, Turkey, Belgium, Norway, Poland, Israel, India, Taiwan, Denmark, Singapore, Ireland and Mexico registers. 26 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Sanofi (3). The most-studied condition is Immunosuppression. The EU clinical trials register (CTIS) separately lists 9 authorised or ongoing trials.
Where Tacrolimus is approved
All regulators →Of the three regulators tracked here, the first to approve Tacrolimus was the US, on 8 Apr 1994. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of vernal keratoconjunctivitis (25 Mar 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.
Tacrolimus patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tacrolimus, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 30 Aug 2028 (US 8664239).
- Exclusivity ODE-360: Orphan drug exclusivity: for prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant, until 16 Jul 2028.
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 Tacrolimus
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 Tacrolimus works
All drug targets →- FK506-binding protein 1A inhibitor InhibitorTarget: FKBP1A FKBP prolyl isomerase 1A✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Acute lymphoblastic leukemiaPhase 3
- Acute myeloid leukemiaPhase 3
- AtherosclerosisPhase 3
- Chronic kidney diseasePhase 3
- Dry eye syndromePhase 3
- Hematopoietic and lymphoid cell neoplasmPhase 3
- Infertility disorderPhase 3
- InjuryPhase 3
- Kidney disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL269732, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6784, 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 Tacrolimus
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Tacrolimus. 4 are current, and 4 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 |
| Immunosuppressive therapy for renal transplantation in children and adolescents NICE TA99 | Not recommended Recommended Optimised | 26 Apr 2006 | Current |
| Tacrolimus and pimecrolimus for atopic eczema NICE TA82 | 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 Tacrolimus
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 35 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 Tacrolimus
- ChEMBL
- CHEMBL269732
- DrugBank
- DB00864
- PubChem CID
- 445643
- CAS number
- 104987-11-3
- FDA UNII
- Y5L2157C4J
- Wikidata
- Q411648
- Wikipedia
- Tacrolimus
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 Tacrolimus
47 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.
Tacrolimus in the EU trials register (CTIS)
9 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Tacrolimus. 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.
Tacrolimus 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)
35 single-substance products containing Tacrolimus on the HPRA medicines list.
- Prograf 0.5 mg hard capsulesAstellas Pharma Co. Limited · PA1241/014/001 · Marketed
- Prograf 1 mg hard capsulesAstellas Pharma Co. Limited · PA1241/014/002 · Marketed
- Prograf 5 mg hard capsulesAstellas Pharma Co. Limited · PA1241/014/003 · Marketed
- Prograf 5 mg/ml concentrate for solution for infusionAstellas Pharma Co. Limited · PA1241/014/004 · Marketed
- Tacrolimus 0.03% ointmentAccord Healthcare Ireland Ltd. · PA2315/269/001 · Marketed
Supply shortages
- Tacrolimus AL 3 mg Hartkapseln, retardiertGermany (BfArM) · Other reason · 15 Feb 2025 to 31 Dec 2026
- Tacrolimus AL 3 mg Hartkapseln, retardiertGermany (BfArM) · Other reason · 15 Feb 2025 to 31 Dec 2026
- Tacrolimus AL 0,5 mg Hartkapseln, retardiertGermany (BfArM) · Other reason · 15 Feb 2025 to 31 Dec 2026
- Tacrolimus AL 0,5 mg Hartkapseln, retardiertGermany (BfArM) · Other reason · 15 Feb 2025 to 31 Dec 2026
- Tacrolimus AL 1 mg Hartkapseln, retardiertGermany (BfArM) · Other reason · 15 Feb 2025 to 31 Dec 2026
- Tacrolimus AL 1 mg Hartkapseln, retardiertGermany (BfArM) · Other reason · 15 Feb 2025 to 31 Dec 2026
+ 7 more German shortage notices.
Conditions studied with Tacrolimus
63 conditionsAll 63 conditions
| Condition (as registered) | Trials |
|---|---|
| Immunosuppression | 6 |
| Primary Membranous Nephropathy | 4 |
| Vitiligo | 4 |
| Liver Transplantation | 4 |
| Kidney Transplant Rejection | 2 |
| Age-Related Macular Degeneration | 2 |
| Dermatomyositis | 2 |
| Kidney Transplant | 2 |
| Renal Allograft Recipients | 1 |
| Dermatitis Atopic | 1 |
| Transplant Rejection | 1 |
| Glomerulonephritis, Membranous | 1 |
| Graft-versus-host Disease (GVHD) | 1 |
| Transplantation, Kidney | 1 |
| Post-ERCP Acute Pancreatitis | 1 |
| Retinal Disease | 1 |
| Macular Degeneration | 1 |
| Geographic Atrophy | 1 |
| Child | 1 |
| Progressive Disease | 1 |
| Mesenchymal Stem Cells | 1 |
| Exosomes | 1 |
| Ocular Myasthenia Gravis | 1 |
| Immune Tolerance | 1 |
| Liver Transplant; Complications | 1 |
| Neuroblastoma | 1 |
| Liver Transplant | 1 |
| Liver Allograft | 1 |
| Liver Diseases | 1 |
| Myelodysplastic Syndromes | 1 |
| Secondary Acute Myeloid Leukemia | 1 |
| Chronic Myelomonocytic Leukemia | 1 |
| Organ Grafts | 1 |
| Kidney Disease, Chronic | 1 |
| Transplant Recipient (Kidney) | 1 |
| Post-ERCP Pancreatitis | 1 |
| Renal Transplant Recipients | 1 |
| Elderly Patients | 1 |
| Dyskeratosis Congenita | 1 |
| Hoyeraal Hreidarsson Syndrome | 1 |
| Revesz Syndrome | 1 |
| Aplastic Anemia | 1 |
| Lymphedema | 1 |
| Sickle Cell Disease | 1 |
| Organ Transplant Failure or Rejection | 1 |
| Brain Death | 1 |
| Ischemic Reperfusion Injury | 1 |
| Neurotoxicity | 1 |
| Tremor | 1 |
| Acute Lymphoblastic Leukemia | 1 |
| Acute Myeloid Leukemia | 1 |
| Mixed Phenotype Acute Leukemia | 1 |
| Myelodysplastic Syndrome | 1 |
| Oral Erosive Lichen Planus | 1 |
| Interstitial Lung Disease | 1 |
| Myositis | 1 |
| Solid Organ Transplant | 1 |
| Nonsegmental Vitiligo | 1 |
| Non-Segmental Vitiligo (NSV) | 1 |
| Stable Vitiligo | 1 |
| Atopic Dermatitis | 1 |
| Psoriasis | 1 |
| Psoriasis Genital | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Sanofi | 3 |
| Cairo University | 3 |
| Xijing Hospital | 2 |
| Vertex Pharmaceuticals Incorporated | 1 |
| BeOne Medicines | 1 |
| Bristol-Myers Squibb | 1 |
| Eledon Pharmaceuticals | 1 |
| Astellas Institute for Regenerative Medicine | 1 |
| Amgen | 1 |
| Incyte Corporation | 1 |
| Hoffmann-La Roche | 1 |
| Biogen | 1 |
| Veloxis Pharmaceuticals | 1 |
| Johns Hopkins University | 1 |
| Eyestem Research Pvt. Ltd | 1 |
+ 27 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 Tacrolimus trials
How many clinical trials are testing Tacrolimus?
47 current trials in our China, USA, Canada, Spain, Germany, Brazil, France, Italy, Australia, UK, Netherlands, Sweden, Egypt, Czechia, Japan, South Korea, Turkey, Belgium, Norway, Poland, Israel, India, Taiwan, Denmark, Singapore, Ireland and Mexico registers name Tacrolimus (also registered as FK506) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Tacrolimus trials recruiting patients?
Yes. 26 of the 47 trials are recruiting: 7 with sites in China, 8 with sites in USA, 3 with sites in Canada, 5 with sites in Spain, 4 with sites in Germany, 4 with sites in Brazil, 4 with sites in France, 3 with sites in Italy, 4 with sites in Australia, 3 with sites in UK, 3 with sites in Netherlands, 1 with sites in Sweden, 1 with sites in Egypt, 2 with sites in Czechia, 2 with sites in Japan, 2 with sites in South Korea, 2 with sites in Belgium, 2 with sites in Norway, 1 with sites in Poland, 1 with sites in Israel, 3 with sites in India, 1 with sites in Taiwan, 1 with sites in Denmark, 2 with sites in Singapore and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tacrolimus clinical trials?
Sanofi (3), Cairo University (3), Xijing Hospital (2) and Vertex Pharmaceuticals Incorporated (1), among 42 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Tacrolimus 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 Tacrolimus licensed in Ireland?
Yes. The HPRA medicines list includes 35 single-substance products containing Tacrolimus, for example Prograf 0.5 mg hard capsules (Astellas Pharma Co. Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tacrolimus shortage?
The registers we track list 13 entries for Tacrolimus: 13 German notices. 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 Tacrolimus 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 Tacrolimus 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 Tacrolimus (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.