Pimecrolimus

also known as Elidel · Elidel (pimecrolimus) Cream, 1% (Valeant) · Elidel(R) · MR-139 · PIM · SDZ ASM 981

Small molecule targets FKBP1A via inhibition

Developed for: atopic eczema · discoid lupus erythematosus · lichen planus, oral · capillary malformation · dry eye syndrome · exanthem · facial dermatosis · hand dermatosis
+8 more
· Netherton syndrome · oral erosive lichen · pityriasis alba · seborrheic dermatitis · vitiligo · vulvar lichen sclerosus · blepharitis · prurigo nodularis
Investigated by: Novartis · Novartis Pharmaceuticals · Technical University Dresden · Ain Shams University · Beckman Laser Institute University of California Irvine · Center for Vulvovaginal Disorders
+18 more
· Centre Hospitalier Universitaire de Nice · Children's Hospital of Michigan · Children's Hospital of Philadelphia · Dermatology Specialists Research · Deutsche Forschungsgemeinschaft, Bonn, Germany · Glenmark Pharmaceuticals Ltd. India · LEO Pharma · MEDA Pharma GmbH & Co. KG · National Medical Research Center for Children's Health, Russian Federation · Novartis Pharma GmbH, Nürnberg, Germany · Shahid Beheshti University of Medical Sciences · St Joseph University, Beirut, Lebanon · University Hospital Tuebingen · University Hospital, Ghent · University of California, Irvine · University of Kiel · University of Leipzig · West Virginia University

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

today

US approved 2001

NCT03834935 · Ph 2/3 NCT04900948 · Ph 4 NCT02896101 · Ph 3 NCT02103725 · Ph 1 NCT01692626 · Ph 2 NCT02443311 · Ph 4 NCT00969397 · Ph 1/2 NCT00403559 · Ph 2 NCT00810862 · Ph 4 NCT00393263 · Ph 2 NCT00608673 · not/applicable NCT00367393 · Ph 4 NCT00377962 · Ph 4 NCT00232115 · Ph 3 NCT00208026 · Ph 1/2 NCT00130364 · Ph 4 NCT00121381 · Ph 4 NCT00509990 · Ph 4 NCT00180141 · Ph 4 NCT01132079 · not/applicable NCT00120302 · Ph 4 NCT00510003 · Ph 4 NCT00150059 · Ph 4 NCT00321750 · Ph 2 NCT00121316 · Ph 4 NCT00484003 · Ph 4 NCT00139581 · Ph 4 NCT00128245 · Ph 2 NCT00226707 · Ph 3 NCT00130572 · Ph 3 NCT00372307 · Ph 2 NCT00231998 · Ph 3 NCT00232011 · Ph 3 NCT00148746 · not/applicable NCT00120523 · Ph 3 NCT00117377 · Ph 4 NCT00925730 · Ph 4 NCT00124709 · Ph 4 NCT00222183 · not/applicable NCT00351052 · Ph 3

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

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 · 1 missed
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 Stop: Enrollment
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	NCT00510003	Dec 2004 → Jan 2006	atopic eczema	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT00150059	Dec 2004 → Dec 2005	atopic eczema	Novartis	Completed	No outcome recorded
Phase 4	NCT00121316	Oct 2004 → Jul 2005	atopic eczema	Novartis	Completed	No outcome recorded
Phase 4	NCT00484003	Oct → Dec 2004	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	Missed primary

Phase not applicable4 trials · 1 missed
—	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	Missed primary
—	NCT00222183	Jun 2003 → ?	discoid lupus erythematosus	University of Leipzig	Withdrawn	No outcome recorded
Comparator or background therapy23 trials
Phase 1	NCT05729074 Comparator	Feb 2023 → Sep 2024	atopic eczema	HK inno.N Corporation	Completed	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 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	Missed primary
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 3	NCT06400511 Comparator	Apr 2024 → Sep 2025	blepharitis	Famy Life Sciences, a Viatris Company	Terminated	No outcome recorded Stop: Business
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 4	NCT03539601 Comparator	Apr 2018 → Dec 2020	atopic eczema	Pfizer	Terminated	No outcome recorded Stop: Business
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	NCT00666159 Comparator	Dec 2002 → May 2003	atopic eczema	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT00667160 Comparator	Dec 2002 → Nov 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
—	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

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2025-07-18	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Results Viatris Provides Update on Phase 3 Study of MR-139 for Blepharitis viatris.com ↗ Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study.
2019-08-30	Glenmark Pharmaceuticals Ltd. India	Regulatory Glenmark Pharmaceuticals receives ANDA approval for Pimecrolimus Cream, 1% glenmarkpharma.com ↗ Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Pimecrolimus Cream, 1%, a generic version of Elidel®1 Cream, 1%, of Bausch Health US, LLC.

All press releases naming this drug 4 releases

Date	Issuer	Release
2026-07-28	Bausch Health Americas, Inc.	Pr ELIDEL ® (pimecrolimus) cream Now Reimbursed Under Alberta’s Public Drug Plan for Eligible Patients with Mild to Moderate Atopic Dermatitis bauschhealth.com ↗
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 ↗
2019-08-30	Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals receives ANDA approval for Pimecrolimus Cream, 1% glenmarkpharma.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 ↗ NCT00372307 ↗ NCT00128245 ↗ NCT00121316 ↗ NCT00608673 ↗ NCT00925730 ↗ NCT00321750 ↗ NCT01177566 ↗ Show 48 more sources
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 ↗ NCT00403559 ↗ Show 4 more sources
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 ↗