Drug Database
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tacrolimus (Protopic / tacrolimus, topical / M 1151C2)

✓ Approved

Roche · FKBP1A

What is tacrolimus?

tacrolimus is a therapeutic agent developed by Roche. It is approved for therapeutic indications via topical.

Drug Profile

Brand NamesProtopic, tacrolimus, topical, M 1151C2
CompanyRoche
Molecular TargetFKBP1A
RouteTopical
StatusApproved
Sources: ClinicalTrials.gov, Roche

Mechanism of Action

Molecular Targets

tacrolimus acts on 1 molecular target:

FKBP1AFKBP prolyl isomerase 1A (FKBP-12, FKBP12)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

tacrolimus is developed for 3 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersDermatitis allergic✓ Approved
Skin and subcutaneous tissue disordersDermatitis atopic✓ Approved
Skin and subcutaneous tissue disordersPsoriasisPhase II

Related Research Articles

PubMedInternational journal of dermatology2026-10-15

Topical Finasteride 0.25% Solution for Female Pattern Hair Loss (FPHL) in Postmenopausal Women: A 52-Week Retrospective Observational Study.

Piraccini Bianca Maria BM, Gupta Aditya K AK, Cedirian Stephano S, Rapparini Luca L et al.

Female pattern hair loss (FPHL), characterized by progressive follicular miniaturization, is the most common cause of hair thinning in women and increases in prevalence after menopause. While topical minoxidil is approved for FPHL, clinical response is variable. Oral finasteride is used off label in postmenopausal women but raises concerns regarding systemic adverse effects. Topical finasteride may represent an alternative with reduced systemic exposure. A retrospective observational study was conducted in 26 postmenopausal women with FPHL who were treated with topical finasteride 0.25% monotherapy for 52 weeks. Clinical and trichoscopic images obtained at baseline and Week 52 were used to assess changes in hair density, hair thickness, and the terminal-to-vellus hair ratio in predefined target areas in frontal or vertex regions. Patient-reported tolerability and compliance, as well as patient- and clinician-reported effectiveness, were assessed using 3-point ordinal scales. Mean hair density increased from 149.48 ± 34.32 to 172.84 ± 35.29 hairs/cm2 (p < 0.001). Hair thickness increased from 40.42 ± 7.15 μm to 51.04 ± 9.28 μm (p < 0.001), and terminal-to-vellus hair ratio increased from 1.04 ± 0.61 to 1.56 ± 0.64 (p < 0.001). Subjective patient and clinician assessments indicated good-to-excellent effectiveness. No adverse events were recorded; tolerability and compliance were rated highly by patients. Topical finasteride 0.25% monotherapy was associated with significant improvements in hair density and thickness, alongside favorable reported tolerability and compliance. These findings provide preliminary real-world observational data regarding topical finasteride use in the underserved population of postmenopausal women with FPHL.

PMID 42876360
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PubMedFrontiers in cellular and infection microbiology2026-10-15

Etiology, incidence and clinical manifestations of urinary tract infections in evolving population of kidney transplant recipients - a single center 10-year retrospective analysis.

Gołębiewska Justyna E JE, Stefański Krystian K, Pastuszak Krzysztof K, Dębska-Ślizień Alicja A

The aim of the study was to verify how the kidney transplant (KTx) recipient profile changed between 2013 and 2022 and whether these changes influence the incidence, clinical manifestations, and microbiology of urinary tract infections (UTIs). We analyzed clinical data and urine cultures collected during the first posttransplant year in patients who underwent KTx between January 2013 and December 2022. We studied data from 491 patients, who developed 448 episodes of UTIs, including asymptomatic bacteriuria (n=211, 47%), lower UTIs (n=80, 18%), acute graft pyelonephritis (n=97, 22%) and urosepsis (n=60, 13%). During two 5-year time periods (2013-2017 and 2018-2022), the number of recipients aged 70 years or over and 75 years or over increased (p=0.07). Recipients receiving a transplant more recently had higher numbers of mismatching HLA (p=0.001) and maximum CDC-PRA (p=0.001). As a result, in 2018-2022 KTx recipients were more likely to receive induction therapy vs. no induction and tacrolimus vs. cyclosporine-based maintenance immunosuppression (p<0.001). There was a parallel change in the etiology of UTIs, from Escherichia coli being the predominant pathogen (responsible for almost 35% of all UTI episodes in 2013-2017) to Klebsiella pneumoniae, which was isolated in 45% of all UTI episodes between 2018-2022. Klebsiella pneumoniae increased over calendar time (OR/year 1.23, 95% CI 1.08-1.39; p=0.0018). The proportion of highly resistant strains rose from 40.1% in 2013-2017, to 53.4% between 2018-2022 (p=0.008) and also increased in the linear model (p = 0.0369). Over the 10-year period, there was a noticeable change in both KTx recipient and uropathogen characteristics, which requires alteration of antimicrobial prophylaxis and treatment strategies.

PMID 42876619
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PubMedZhonghua er ke za zhi = Chinese journal of pediatrics2026-10-15

[Clinical analysis of 4 children with tubulointerstitial nephritis and uveitis syndrome].

Wang N N NN, Tu J J, Chen C Y CY

Objective: To investigate the clinical and pathological characteristics, treatment, and prognosis of tubulointerstitial nephritis and uveitis (TINU) syndrome in children. Methods: This case series study analyzed the clinical characteristics, laboratory examinations, renal biopsy findings, treatment courses, and outcomes of 4 children diagnosed with TINU syndrome, who were hospitalized in the Department of Nephrology, Capital Center for Children's Health affiliated to Capital Medical University between November 2017 and April 2024. Results: Four children with TINU syndrome included 2 males and 2 females. Their ages at diagnosis were 13 years and 11 months, 13 years and 6 months, 13 years and 7 months, and 11 years and 8 months respectively. Three patients had a history of infection or drug exposure before disease onset. Ocular symptoms preceded renal involvement by 1 month in 1 case, whereas uveitis developed 8.0, 0.5 and 14.0 months after renal involvement in the other 3 cases. All patients had acute kidney injury (AKI), including stage 2 AKI in 3 patients and stage 3 AKI in 1 patient. Glycosuria and elevated urinary β2-microglobulin levels occurred, and varying degrees of proteinuria and leukocyturia occurred in 3 patients. Serum creatinine levels at disease onset were markedly elevated at 130.0, 103.4, 188.4 and 105.7 μmol/L, and estimated glomerular filtration rates were reduced to 50.5, 56.4, 28.9 and 53.8 ml/(min·1.73 m²). Renal biopsies showed acute interstitial nephritis, and the predominant ocular manifestation was bilateral anterior uveitis. All patients received systemic glucocorticoid therapy and topical corticosteroid eye drops, and 1 patient was additionally treated with mycophenolate mofetil. During follow-up periods of 57, 82, 14 and 66 months, respectively, 1 patient progressed to stage 2 chronic kidney disease. Proteinuria resolved and ocular symptoms recurred only in 1 patient. Conclusions: Renal involvement generally has a favorable prognosis in children with TINU syndrome. However renal function may not fully recover in some patients, and uveitis may persist or recur, underscoring the need for renal and ophthalmic combined screening and long-term multidisciplinary follow-up.

PMID 42876103
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PubMedEvidence-based dentistry2026-10-15

How do different topical fluoride applications affect salivary and plaque fluoride levels for young children with dental caries?

Timms Laura L, Marshman Zoe Z

Asavalertpalakorn C, Jirarattanasopha V, Nakornchai S, Horsophonphong S. Plaque and salivary fluoride levels in preschoolers following applications of silver diamine fluoride, sodium fluoride varnish, and their combination: a randomized clinical trial. Int J Paediatr Dent. 2026;36:81-9. https://doi.org/10.1111/ipd.70030 . A three-arm randomised controlled trial compared the salivary and plaque fluoride levels for young children, following application of different fluoride prevention and treatment procedures (silver diamine fluoride, sodium fluoride varnish and silver diamine fluoride and sodium fluoride varnish together), in child development centres in Thailand. Children aged 3-6 were selected who had at least one carious tooth reaching dentine in the primary dentition. Included children were considered healthy and co-operative. Children who had received professional fluoride application within the last three months were excluded, or those with a known allergy to any component. Twenty children were randomised to each group. Group 1 received silver diamine fluoride application (1 drop) to dentinal carious lesions; group 2 received sodium fluoride varnish application (0.25 ml) to all erupted primary teeth; group 3 received both the silver diamine fluoride and sodium fluoride varnish interventions. Fluoride applications were not applied to pulpally involved teeth. Plaque and saliva samples were collected at baseline (prior to fluoride application), at 5, 30 and 60 minutes, and at 24 and 48 hours. Kruskal-Wallis and Friedman tests were used to compare the 3 groups at the various time points. A Bonferroni correction was applied to account for the multiple comparisons. In total, 60 children were randomised, data were analysed for 50 children's salivary samples and 49 children's plaque samples. The mean age was 3.7 months, with children having a mean of 7.6 decayed, missing or filled teeth. At the shorter-term (5, 30 and 60 minute) time points, the salivary fluoride levels were significantly higher in the sodium fluoride varnish alone and silver diamine fluoride with sodium fluoride varnish groups than in the silver diamine fluoride alone group. There was no difference in the silver diamine fluoride with sodium fluoride varnish and sodium fluoride varnish alone groups for both salivary and plaque fluoride levels. Considering fluoride levels in plaque, the sodium fluoride varnish group had significantly higher levels at 5 and 60 minutes than the silver diamine fluoride group and the silver diamine fluoride with sodium fluoride varnish group was significantly higher at 30 and 60 minutes in comparison to silver diamine fluoride alone. At 60 minutes, the silver diamine fluoride and sodium fluoride varnish groups had returned to baseline; this was at 24 hours for the silver diamine fluoride with sodium fluoride varnish group for salivary fluoride. For plaque levels, the return to baseline was at 60 minutes for the silver diamine fluoride group, and 24 hours for the sodium fluoride varnish and silver diamine fluoride with sodium fluoride varnish groups. Children receiving sodium fluoride varnish and silver diamine fluoride had higher plaque and salivary fluoride levels than those treated with silver diamine fluoride alone in the short term. Plaque and salivary fluoride levels returned to baseline at 24 hours for all groups.

PMID 42875550
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PubMedJournal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics2026-10-14

Topical Tacrolimus in Ocular Disease: A Narrative Review of Mechanism of Action and Therapeutic Applications.

Abu Serhan Hashem H, Abu Al-Burak Salem S, Hassan Lameece L, Alshammari Mohammad M et al.

Immune-mediated inflammatory disorders of the ocular surface and anterior segment frequently require sustained immunosuppression, yet prolonged topical corticosteroid use carries the risk of glaucoma, cataract, and infection. Tacrolimus, a macrolide calcineurin inhibitor, has emerged as a steroid-sparing alternative for T-cell-mediated ocular disease. This review summarizes the mechanism of action, ocular pharmacology, clinical applications, and safety profile of topical tacrolimus. Narrative synthesis of the peer-reviewed literature. Tacrolimus binds the immunophilin FK506-binding protein 12; the resulting complex inhibits the phosphatase calcineurin, preventing dephosphorylation and nuclear translocation of the nuclear factor of activated T-cells (NFAT) and thereby suppressing transcription of interleukin-2 and a broad program of pro-inflammatory cytokines. The downstream result is reduced activation across the Th1, Th2, and Th17 lineages, diminished T-follicular helper and B-cell responses, stabilization of mast cells and eosinophils, and anti-angiogenic effects. Compounded topical formulations (typically 0.01%-0.1%) penetrate the cornea and reach therapeutic aqueous concentrations. Topical tacrolimus has shown efficacy in vernal and atopic keratoconjunctivitis, anterior uveitis, scleritis, ocular graft-versus-host disease, cicatrizing conjunctivitis, Thygeson superficial punctate keratitis, autoimmune polyglandular syndrome-1-associated keratitis, and corneal graft rejection. Topical tacrolimus is an effective steroid-sparing immunomodulator for a broad spectrum of T-cell-mediated ocular disease, with a favorable safety profile notable for the absence of steroid-related rises in intraocular pressure or cataractogenesis. Standardized formulations and prospective comparative trials remain priorities.

PMID 42870636
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PubMedTransplantation proceedings2026-10-14

Profound Tacrolimus-Induced Catatonic Encephalopathy in a Kidney Transplant Recipient With Mitochondrial Myopathy: A Cautionary Case of Reversible Neurotoxicity.

Ripa Valeria V, Geffner Stuart R SR, Rosenzweig Matthew G MG, Hanlon Matthew M et al.

Maternally inherited diabetes and deafness (MIDD) is a multisystem mitochondrial disorder most commonly caused by the m.3243A>G pathogenic variant in the MT-TL1 gene. Kidney transplantation in affected individuals presents unique perioperative and immunosuppressive management challenges due to underlying metabolic, neurologic, cardiac, and neuromuscular vulnerability. We report a 64-year-old woman with end-stage renal disease secondary to insulin-dependent diabetes and MIDD (m.3243A>G) who underwent unrelated living donor kidney transplantation. The immediate postoperative period was complicated by diabetic ketoacidosis with lactic acidosis, transient slow graft function, and profound encephalopathy with catatonic features. Neuroimaging showed no acute abnormalities, and electroencephalography demonstrated severe diffuse encephalopathy without epileptiform activity. Tacrolimus levels were supratherapeutic in the early postoperative period. Given concern for calcineurin inhibitor neurotoxicity superimposed on mitochondrial dysfunction, tacrolimus was discontinued, and immunosuppression was switched to cyclosporine. Neurologic status gradually improved, and kidney allograft function fully normalized. This case highlights the substantial perioperative metabolic and neurologic risks associated with kidney transplantation in patients with MIDD. Patients with compensated cardiac dysfunction and manageable neuromuscular impairment should not be excluded from transplantation solely on the basis of mitochondrial cytopathy.

PMID 42875311
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