Micafungin
| Evidence Level: L3 | Predicted Indications: 1 |
Table of Contents
- Micafungin
- Pharmacist Assessment Report
- Micafungin: From Esophageal Candidiasis and Candidemia to urinary tract infection
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Micafungin: From Esophageal Candidiasis and Candidemia to urinary tract infection
One-Sentence Summary
Micafungin is an echinocandin antifungal, originally used to treat esophageal candidiasis, candidemia and disseminated candidiasis. The TxGNN model predicts it may be effective for urinary tract infection (Candida UTI / candiduria). Currently there are no registered clinical trials, but 13 publications (mostly cohort studies, case reports and case series) support this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Esophageal candidiasis, candidemia, disseminated candidiasis (the licence records compiled for this report contain no approved indication text) |
| Predicted New Indication | Urinary tract infection |
| TxGNN Prediction Score | 0.9903 |
| Evidence Level | L3 |
| India Market Status | Listed in a compiled Indian medicine price dataset (19 of 19) – CDSCO approval status is not included in this data |
| Number of Listed Products | 19 (valid: 19) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known class information, micafungin is an echinocandin that inhibits 1,3-beta-D-glucan synthase and disrupts fungal cell wall synthesis. It is established for invasive Candida infections (candidemia, esophageal and disseminated candidiasis).
Candida species are the main fungal cause of urinary tract infection. The new indication is therefore the same pathogen family as the original indications, not a new mechanism. Activity against the causative organisms is plausible, and this is a notable strength of the prediction.
There is a pharmacokinetic caveat. Echinocandins have traditionally been considered poorly suited to UTI because little active drug is excreted in urine. However, one report (PMID 27424599) found urinary micafungin levels sufficient to treat Candida UTIs, which partly offsets this concern. The high TxGNN score is consistent with this reasoning, but it is a model prediction and not clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35146837 | 2022 | Cohort | Pediatr Int | Micafungin for hospital-acquired Candida UTI in critically ill children; treatment success rates analysed overall and by Candida species |
| 27587066 | 2016 | Cohort | Int Urol Nephrol | Candiduria elimination rates in hospitalized patients treated with micafungin |
| 27424599 | 2016 | Pharmacokinetic study / case series | Int J Antimicrob Agents | Six UTI cases treated successfully, four with fluconazole-resistant Candida; urinary micafungin levels were sufficient |
| 26937340 | 2016 | Case series | Med Mycol Case Rep | Five candiduria cases; fungal clearance within 30 days of finishing at least 6 days of micafungin |
| 31111613 | 2019 | Case report | Transpl Infect Dis | Chronic C. krusei UTI eradicated with increased-dose micafungin in a liver and kidney transplant recipient |
| 38827222 | 2024 | Case report | Front Pediatr | C. glabrata urinary infection in a premature neonate treated with micafungin |
| 38681664 | 2024 | Case report | Med Mycol Case Rep | Renal fungus ball from C. glabrata (micafungin-sensitive), treated with antifungals plus endoscopic extraction |
| 40765059 | 2025 | Case report | J Pharm Health Care Sci | C. glabrata pyelonephritis and bacteraemia in a patient on an SGLT2 inhibitor, successfully treated with micafungin |
| 40405904 | 2025 | Case report | Cureus | Urosepsis from nephrolithiasis caused by C. glabrata in an immunocompetent patient |
| 33520520 | 2020 | Case report | Cureus | C. auris UTI in a nursing home patient with multiple comorbidities |
| 29109159 | 2018 | Cohort | Antimicrob Agents Chemother | Multi-centre study showing overtreatment of asymptomatic candiduria; guidelines do not recommend antifungals for it |
| 39781278 | 2025 | Susceptibility survey | Ther Adv Infect Dis | Candida species distribution and antifungal susceptibility in vulvovaginal candidiasis and UTI in Vietnam |
| 24182454 | 2014 | Epidemiology | Int J Antimicrob Agents | US Candida bloodstream infection species distribution and susceptibility (background context) |
No randomized controlled trials were identified. Several of these papers are background or epidemiology studies rather than direct efficacy evidence.
India Market Information
Micafungin is marketed in India with 19 valid single-ingredient registrations. Approved indication text is not available in the compiled licence records. Five main registrations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 135018 | Mycamine 100mg Injection (Astellas Pharma Inc) | Vial of 1 injection | Not stated in licence records |
| 134987 | Mycamine 50mg Injection (Glaxo SmithKline Pharmaceuticals Ltd) | Vial of 1 ml injection | Not stated in licence records |
| 137943 | Micanfa 50mg Injection (Intas Pharmaceuticals Ltd) | Vial of 5 ml injection | Not stated in licence records |
| 138535 | Micalan Injection (Mylan Pharmaceuticals Pvt Ltd) | Vial of 1 injection | Not stated in licence records |
| 90148 | Fungofine 50mg Injection (Dr Reddy’s Laboratories Ltd) | Vial of 1 injection | Not stated in licence records |
All formulations are injectable. This matters for UTI use because the product would be given intravenously.
Safety Considerations
- Disease-related cautions (knowledge graph): Kidney disease and pyoureter are flagged as contraindication-related conditions. These come from a drug-disease knowledge graph, not from label text, and should be verified against the package insert. They are relevant because UTI patients may have renal or urinary tract pathology.
- Drug Interactions: Five moderate-level interactions were identified: amphotericin B, nitisinone, everolimus, ribociclib and sirolimus. The sirolimus and everolimus interactions matter in transplant patients, who are a common candiduria population.
Please also refer to the package insert for full warnings and contraindications, which were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is plausible and the TxGNN score is high. However, the supporting evidence is limited to cohort studies, case series and case reports, with no registered trials and no randomized data. Echinocandins also face a recognised limitation of low urinary excretion, and guidelines do not support treating asymptomatic candiduria. Package insert safety data is also missing, so safety screening cannot yet be completed.
To proceed, the following is needed:
- Package insert warnings and contraindications for India-marketed products, to complete safety screening
- Detailed mechanism of action data
- Controlled or prospective clinical data on micafungin for Candida UTI, including urinary concentration and microbiological clearance outcomes
- Clear definition of the target population (symptomatic Candida UTI or fluconazole-resistant organisms, as opposed to asymptomatic candiduria)
- Review of renal safety in patients with kidney disease and of immunosuppressant interactions in transplant patients
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.