Pimecrolimus

Overview

Pimecrolimus is an immunomodulating agent that was first marketed by Novartis under the trade name Elidel. It is now promoted in Canada by Galderma since early 2007. It is currently available as a topic cream used in the treatment of atopic dermatitis (eczema).

Indication

For treatment of mild to moderate atopic dermatitis.

Associated Conditions

Vitiligo
Intertriginous psoriasis
Mild Atopic dermatitis
Moderate Atopic dermatitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment	2024/05/06	NCT06400511	Phase 3	Active, not recruiting	Famy Life Sciences, a Viatris Company
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	2024/02/05	NCT06241118	Phase 3	Recruiting	Sanofi
Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.	2023/09/25	NCT06052995	N/A	Not yet recruiting	MEDA PHARMA SPA, a Viatris company
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients	2023/02/15	NCT05729074	Phase 1	Not yet recruiting	HK inno.N Corporation
Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis	2021/07/26	NCT04976868	N/A	Completed	Mylan Inc.
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life	2021/05/25	NCT04900948	Phase 4	Completed	National Medical Research Center for Children's Health, Russian Federation
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba	2019/02/08	NCT03834935	Phase 2	UNKNOWN	St Joseph University, Beirut, Lebanon
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD	2018/05/29	NCT03539601	Phase 4	Terminated	Pfizer
Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis	2017/09/29	NCT03297502	Phase 3	Completed	Par Pharmaceutical, Inc.
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis	2017/04/11	NCT03107611	Phase 3	Completed	Mylan Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ELIDEL	Bausch Health US, LLC	0187-5101	TOPICAL	10 mg in 1 g	9/30/2020
Pimecrolimus	Bryant Ranch Prepack	72162-1889	TOPICAL	10 mg in 1 g	3/21/2024
ELIDEL	Bausch Health US, LLC	0187-5100	TOPICAL	10 mg in 1 g	9/30/2020
Pimecrolimus	Bryant Ranch Prepack	72162-1891	TOPICAL	10 mg in 1 g	3/22/2024
Pimecrolimus	Bryant Ranch Prepack	72162-1890	TOPICAL	10 mg in 1 g	3/21/2024
Pimecrolimus	Oceanside Pharmaceuticals	68682-110	TOPICAL	10 mg in 1 g	9/30/2020
ELIDEL	Bausch Health US, LLC	0187-5103	TOPICAL	10 mg in 1 g	9/30/2020
Pimecrolimus	Oceanside Pharmaceuticals	68682-112	TOPICAL	10 mg in 1 g	9/30/2020
Pimecrolimus	Oceanside Pharmaceuticals	68682-111	TOPICAL	10 mg in 1 g	9/30/2020
Elidel	Physicians Total Care, Inc.	54868-4878	TOPICAL	10 mg in 1 g	8/31/2010

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ELIDEL CREAM 1% w/w	NOVARTIS PHARMA PRODUKTIONS GMBH, MEDA Manufacturing	SIN12179P	CREAM	10 mg/g	1/31/2003

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ELIDEL pimecrolimus 1% w/w cream tube	93680	Viatris Pty Ltd	Medicine	A	6/5/2003

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ELIDEL	bausch health, canada inc.	02247238	Cream - Topical	1 % / W/W	3/24/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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