Pimecrolimus clinical trials
Pimecrolimus is named as an intervention in 3 current clinical trials in our USA, Poland, UK, China, Germany, France, Spain, Italy, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia and Israel registers. None are recruiting at the moment. The most common phase is Phase 3. The sponsor with the most trials is Sanofi (1). The most-studied condition is Dermatitis Atopic. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Pimecrolimus is approved
All regulators →Of the three regulators tracked here, the first to approve Pimecrolimus was the US, on 13 Dec 2001. It is approved in 2 of the 3 regulators tracked here.
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.
What health systems spend on Pimecrolimus
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 Pimecrolimus works
All drug targets →- FK506-binding protein 1A inhibitor InhibitorTarget: FKBP1A FKBP prolyl isomerase 1A✓ In ChEMBL and the Guide to Pharmacology
- Dermatitis, PerioralPhase 3
- BlepharitisPhase 3
- Hand eczemaPhase 3
- Oral lichen planusPhase 3
- Dry eye syndromePhase 2
- Lichen diseasePhase 2
- Lichen planusPhase 2
- Prurigo nodularisPhase 2
- Seborrheic dermatitisPhase 2
- VitiligoPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1200686, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6783, 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 Pimecrolimus
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Pimecrolimus. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| 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 Pimecrolimus
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- 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 Pimecrolimus
- ATC code
- D11AH02
- ChEMBL
- CHEMBL1200686
- DrugBank
- DB00337
- PubChem CID
- 6509979
- CAS number
- 137071-32-0
- FDA UNII
- 7KYV510875
- Wikidata
- Q417489
- Wikipedia
- Pimecrolimus
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 Pimecrolimus
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.
NCT07240389 · ClinicalTrials.gov ↗ · Vulvar Lichen Sclerosus
|
Not applicable | Not yet open | Milosz Pietrus | Poland |
|
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
NCT06241118 · Dermatitis Atopic
|
Phase 3 | Active, closed | Sanofi | UK, USA, China, Germany, France, Spain, Italy, Poland, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel |
|
10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
NCT00568997 · ClinicalTrials.gov ↗ · Atopic Dermatitis
|
Observational | Active, closed | Bausch Health Americas, Inc | USA |
Registers 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.
Pimecrolimus in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Pimecrolimus. 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 |
|---|---|---|---|---|
|
A 52-week multi-center, randomized, double-blind, placebo- controlled phase 3 study to evaluate the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO)
2025-524497-41-00 · CTIS ↗ · Immune System Diseases
|
Phase 3 | Authorised | Novartis Pharma AG | Germany, Austria, Poland + 3 more |
Conditions studied with Pimecrolimus
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Sanofi | 1 |
| Bausch Health Americas, Inc | 1 |
| Milosz Pietrus | 1 |
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 Pimecrolimus trials
How many clinical trials are testing Pimecrolimus?
3 current trials in our USA, Poland, UK, China, Germany, France, Spain, Italy, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia and Israel registers name Pimecrolimus as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Pimecrolimus trials recruiting patients?
Not at the moment. None of the 3 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.
Who sponsors Pimecrolimus clinical trials?
Sanofi (1), Bausch Health Americas, Inc (1) and Milosz Pietrus (1). The number in brackets is how many trials each organisation leads.
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 Pimecrolimus 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 Pimecrolimus 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 Pimecrolimus (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.