NDATOPICALOINTMENT
Approved
Dec 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROTOPIC (tacrolimus) by Leo Pharma is protein, fkbp-12. First approved in 2000.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROTOPIC (tacrolimus) is a topical calcineurin inhibitor ointment approved in 2000 for atopic dermatitis and other inflammatory skin conditions. It works by inhibiting T-lymphocyte activation through FKBP-12 binding and calcineurin suppression, thereby reducing pro-inflammatory cytokine production. The mechanism enables localized immunosuppression without systemic absorption typical of topical corticosteroids.
$0.011BPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D volume (~18 claims in 2023), indicating a contracted market footprint and likely reduced commercial headcount.
Mechanism of Action
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed, after which the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Started Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
Started May 2026
300 enrolled
Pulmonary Arterial HypertensionPulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)+2 more
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Started Mar 2026
92 enrolled
Kidney Transplant RecipientsOld Age
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Started Mar 2026
526 enrolled
Kidney Transplant Rejection
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
Started May 2025
120 enrolled
Kidney Transplant
Worked on PROTOPIC at Leo Pharma? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.