Drugs / Pimecrolimus
Pimecrolimus
also known as
Elidel · Elidel (pimecrolimus) Cream, 1% (Valeant) · Elidel(R) · MR-139 · PIM · SDZ ASM 981
Small molecule targets FKBP1A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ELIDEL | — | 2001-12-13 | fda.gov ↗ |
Trials 40 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02103725 | Apr → Sep 2014 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00969397 | Nov 2009 → Sep 2011 | capillary malformation | University of California, Irvine | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00208026 | Sep 2005 → Mar 2008 | Netherton syndrome | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT01692626 | Feb 2012 → Apr 2014 | exanthem | West Virginia University | Terminated | No outcome recorded |
| Phase 2 | NCT00403559 | May 2007 → Feb 2009 | seborrheic dermatitis | Dermatology Specialists Research | Completed | No outcome recorded |
| Phase 2 | NCT00393263 | Oct 2006 → Oct 2009 | vulvar lichen sclerosus | Center for Vulvovaginal Disorders | Completed | No outcome recorded |
| Phase 2 | NCT00321750 | Dec 2004 → Apr 2005 | oral erosive lichen | Centre Hospitalier Universitaire de Nice | Terminated | No outcome recorded |
| Phase 2 | NCT00128245 | Sep 2004 → Dec 2006 | dry eye syndrome | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00372307 | May → Nov 2004 | vitiligo | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03834935 | Mar 2019 → Feb 2021 | pityriasis alba | St Joseph University, Beirut, Lebanon | Unknown | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT02896101 | Aug 2016 → Jun 2017 | atopic eczema | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 3 | NCT00232115 | Sep 2005 → Jul 2006 | facial dermatosis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00226707 | Jul 2004 → Mar 2005 | hand dermatosis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00130572 | Jun 2004 → Dec 2007 | lichen planus, oral | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 3 | NCT00231998 | May 2004 → Jun 2005 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00232011 | May 2004 → May 2005 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00120523 | Apr 2004 → Oct 2010 | atopic eczema | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 3 | NCT00351052 | Dec 2001 → Sep 2004 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT04900948 | Dec 2017 → Apr 2020 | atopic eczema | National Medical Research Center for Children's Health, Russian Federation | Completed | No outcome recorded |
| Phase 4 | NCT02443311 | Sep 2010 → Jun 2012 | lichen planus, oral | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT00810862 | Nov 2006 → Jun 2008 | atopic eczema | Children's Hospital of Michigan | Terminated | No outcome recorded |
| Phase 4 | NCT00367393 | Mar 2006 → Dec 2007 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00377962 | Dec 2005 → Feb 2010 | disease related to solid organ transplantation | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00130364 | Aug 2005 → Aug 2006 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00121381 | May 2005 → Jan 2007 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00509990 | Apr 2005 → Sep 2007 | atopic eczema | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00180141 | Apr 2005 → Mar 2007 | atopic eczema | Technical University Dresden | Completed | No outcome recorded |
| Phase 4 | NCT00120302 | Mar 2005 → Jan 2006 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00150059 | Dec 2004 → Dec 2005 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00510003 | Dec 2004 → Jan 2006 | atopic eczema | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00484003 | Oct → Dec 2004 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00121316 | Oct 2004 → Jul 2005 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00139581 | Sep 2004 → Sep 2005 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00117377 | Apr 2004 → Jun 2005 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00925730 | Mar 2004 → Jan 2006 | atopic eczema | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00124709 | Oct 2003 → Jan 2008 | atopic eczema | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT00608673 | Apr 2006 → Jul 2007 | discoid lupus erythematosus | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| — | NCT01132079 | Mar 2005 → ? | atopic eczema | University of Kiel | Completed | No outcome recorded |
| — | NCT00148746 | May 2004 → Sep 2006 | atopic eczema | Technical University Dresden | Completed | No outcome recorded |
| — | NCT00222183 | Jun 2003 → ? | discoid lupus erythematosus | University of Leipzig | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05729074 Comparator | Feb 2023 | atopic eczema | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT02376049 Comparator | Feb → Jul 2015 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00655512 Comparator | Jan → Jun 2008 | — | Technical University Dresden | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT02583022 Comparator | Jun 2013 → Jan 2014 | atopic eczema | Amorepacific Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01037881 Comparator | Dec 2009 → Jun 2010 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01524744 Comparator | Mar 2009 → Oct 2012 | lichen planus, oral | Mashhad University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT00610142 Comparator | Dec 2007 → Aug 2008 | atopic eczema | Technical University Dresden | Completed | No outcome recorded |
| Phase 2 | NCT00507832 Comparator | Apr 2007 → Jun 2009 | prurigo nodularis | University Hospital Muenster | Completed | No outcome recorded |
| Phase 2 | NCT00297037 Comparator | Aug 2005 → Feb 2009 | lichen planus, oral | University of Utah | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06400511 Comparator | Apr 2024 → Sep 2025 | blepharitis | Famy Life Sciences, a Viatris Company | Terminated | No outcome recorded |
| Phase 3 | NCT06241118 Background | Feb 2024 → Sep 2027 expected | atopic eczema | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT02791308 Comparator | Feb 2015 → Jul 2016 | atopic eczema | Actavis Inc. | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT03539601 Comparator | Apr 2018 → Dec 2020 | atopic eczema | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT01082393 Comparator | Feb 2010 → Sep 2015 | vitiligo | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT01177566 Comparator | Sep 2009 → Mar 2010 | atopic eczema | Emer, Jason, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00568412 Comparator | Dec 2007 → Sep 2008 | atopic eczema | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00460083 Comparator | Apr → Dec 2007 | atopic eczema | Ceragenix Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00119158 Comparator | Oct 2004 → Jun 2005 | atopic eczema | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 4 | NCT00667160 Comparator | Dec 2002 → Nov 2003 | atopic eczema | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00666159 Comparator | Dec 2002 → May 2003 | atopic eczema | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00666302 Comparator | Oct 2002 → Nov 2003 | atopic eczema | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07240389 Comparator | Dec 2025 → Dec 2026 expected | vulvar lichen sclerosus | Milosz Pietrus | Not yet recruiting | No outcome recorded |
| — | NCT00946478 Comparator | Oct 2009 → Feb 2011 | atopic eczema | University of California, San Diego | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Provides Update on Phase 3 Study of MR-139 for Blepharitis viatris.com ↗ |
| 2018-12-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces US Launch of a Generic Version of Elidel® (Pimecrolimus) Cream, 1% tevapharm.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pimecrolimus | “The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.” NCT00969397 ↗58“In a randomized study 15 patients with AD were treated on one upper limb with pimecrolimus and on the other with betamethasone twice daily for 3 weeks.” PMID 19410693 ↗ May 2009 “Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.” NCT00377962 ↗ “Elidel® cream (pimecrolimus) 10 mg/g” NCT01037881 ↗ |
| Known as | Elidel | “In this study the investigators will use a cream called pimecrolimus (Elidel) to see if it will help prevent the rash or keep the rash from getting worse.” NCT01692626 ↗14“This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the corresponding vehicle” NCT00222183 ↗ “Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease” NCT00507832 ↗ “Pimecrolimus cream 1% (Elidel®, Novartis Pharmaceutical) is a topical calcineurin inhibitor” NCT00393263 ↗ “Pimecrolimus 1% cream (Elidel, Novartis Pharmaceuticals, East Hanover, NJ)” NCT02443311 ↗ “Elidel Cream 1% (pimecrolimus), 3 g/1000 cm2” NCT05729074 ↗ “Elidel® (pimecrolimus) cream 1%” NCT01177566 ↗ “ELIDEL® (Pimecrolimus) Cream” NCT02896101 ↗ “Pimecrolimus Cream (Elidel)” NCT07240389 ↗ “Elidel (pimecrolimus 1%)” NCT03834935 ↗ |
| Known as | Elidel (pimecrolimus) Cream, 1% (Valeant) | “Elidel® (pimecrolimus) Cream, 1% (Valeant)” NCT02791308 ↗ |
| Known as | Elidel(R) | “Elidel(R) (pimecrolimus 1%)” NCT00460083 ↗ |
| Known as | MR-139 | “The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.” NCT06400511 ↗ |
| Known as | PIM | “pimecrolimus 1% cream (PIM) was compared with TCSs.” PMID 25802354 ↗ Mar 2015 |
| Known as | SDZ ASM 981 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200686 ↗ |
| Action | Inhibit | “The active ingredient of pimecrolimus inhibits the T-cell activation.” NCT00121381 ↗1“FK506-binding protein 1A inhibitor” CHEMBL1200686 ↗ |
| Modality | Small molecule | “Pimecrolimus is an ascomycin and macrolactam derivative” NCT00222183 ↗ |
| Route | Topical | “Pimecrolimus cream 1 % bid” NCT00117377 ↗ |
| Target | FKBP1A | “FK506-binding protein 1A inhibitor” CHEMBL1200686 ↗ |