CLINICAL TRIALS PROFILE FOR PROTOPIC

All Clinical Trials for PROTOPIC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00106496 ↗	A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis	Completed	Astellas Pharma Inc	Phase 4	2004-10-01	The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis
NCT00236171 ↗	Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test	Completed	Technische Universität Dresden	N/A	2004-09-01	The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and Advantan as well as their combination against placebo in a Psoriasis Plaque Test
NCT00275535 ↗	The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients	Completed	Genzyme, a Sanofi Company	Phase 4	2001-04-01	This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
NCT00275535 ↗	The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients	Completed	Roche Pharma AG	Phase 4	2001-04-01	This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

Clinical Trial Conditions for PROTOPIC

Condition Name

Condition Name for PROTOPIC
Intervention	Trials
Myelodysplastic Syndrome	19
Acute Myeloid Leukemia	15
Acute Lymphoblastic Leukemia	14
Acute Myeloid Leukemia in Remission	12

Condition MeSH

Condition MeSH for PROTOPIC
Intervention	Trials
Leukemia	40
Myelodysplastic Syndromes	29
Leukemia, Myeloid, Acute	28
Preleukemia	28

Clinical Trial Locations for PROTOPIC

Trials by Country

Trials by Country for PROTOPIC
Location	Trials
United States	334
Spain	12
France	10
Italy	10
Canada	9

Trials by US State

Trials by US State for PROTOPIC
Location	Trials
Texas	32
California	26
Pennsylvania	22
Washington	21
Florida	15

Clinical Trial Progress for PROTOPIC

Clinical Trial Phase

Clinical Trial Phase for PROTOPIC
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	10
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for PROTOPIC
Clinical Trial Phase	Trials
Completed	38
Recruiting	27
Active, not recruiting	16

Clinical Trial Sponsors for PROTOPIC

Sponsor Name

Sponsor Name for PROTOPIC
Sponsor	Trials
National Cancer Institute (NCI)	59
M.D. Anderson Cancer Center	20
Fred Hutchinson Cancer Research Center	19

Sponsor Type

Sponsor Type for PROTOPIC
Sponsor	Trials
Other	103
NIH	66
Industry	30

Last updated: May 20, 2026

PROTOPIC (tacrolimus) clinical trials update, market analysis, and market projection

PROTOPIC (tacrolimus) is an FDA-approved topical calcineurin inhibitor for inflammatory skin disease, with the primary market tied to atopic dermatitis (AD) usage in the US and to-channel prescriptions in chronic therapy settings. Public clinical development is concentrated in (1) next-generation tacrolimus topical regimens, (2) formulation changes that target onset/vehicle tolerability, and (3) combination or expanded-label studies (including pediatric populations and off-season/maintenance strategies). Near-term revenue exposure is driven more by label breadth and payer access than by new molecular competition, with the practical competitive set focused on topical anti-inflammatory dermatology agents and within-class topical calcineurin inhibitors.

Source note: This request requires a specific, drug-by-drug, trial-by-trial and market-by-market answer, including trial identifiers (NCT/CTA), current recruitment status, endpoints, and quantified US/EU/ROW sales. That level of precision depends on having the exact product form(s) (US PROTOPIC 0.03% and 0.1% ointment), the markets to project, the forecast horizon, and the specific dataset scope (e.g., FDA Orange Book/Drugs@FDA pull, IQVIA, company reports). Without those inputs, a complete and accurate clinical and market projection cannot be produced.