Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Luliconazole clinical trials

Also listed in trial records as SKX-16
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our USA and Egypt registers that name Luliconazole as an intervention. Synced 14 Nov 2026
2Current trials
1Recruiting now
2Lead sponsors
2Country registers
At a glance

Luliconazole is named as an intervention in 2 current clinical trials in our USA and Egypt registers. 1 is recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is SATO Pharmaceutical Co., Ltd (1). The most-studied condition is Onychomycosis of Toenails.

Where Luliconazole is approved

All regulators →

Of the three regulators tracked here, the first to approve Luliconazole was the US, on 14 Nov 2013.

USUnited States (FDA)
14 Nov 2013
Luzu
NDA204153 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Luliconazole patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Luliconazole, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Luzu
  • 4 listed patents; the last listed expires 28 Apr 2034 (US 8980931).
  • Latest patent on the drug substance itself: 6 Sep 2033 (US 9012484).
See the Orange Book listing for NDA 204153

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Luliconazole

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$15k
89 prescriptions in 2025 · Luliconazole
-63% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

Patient leaflets for Luliconazole

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting150%
  • Not yet open150%

Trials by phase

  • Phase 2150%
  • Not applicable150%
01

Clinical trials of Luliconazole

2 trials
StudyPhaseStatusLead sponsorRegisters
Topical Lactoferrin and Luliconazole, Alone or in Combination, for Tinea Corporis
NCT07937020 · ClinicalTrials.gov ↗ · Tinea Corporis
Not applicable Recruiting Kafrelsheikh University Egypt
Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
NCT07929844 · ClinicalTrials.gov ↗ · Onychomycosis of Toenails
Phase 2 Not yet open SATO Pharmaceutical Co., Ltd USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Luliconazole

2 conditions
Onychomycosis of Toenails1Tinea Corporis1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
SATO Pharmaceutical Co., Ltd1
Kafrelsheikh University1
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA10
Clinical trials in Egypt11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Luliconazole trials

How many clinical trials are testing Luliconazole?

2 current trials in our USA and Egypt registers name Luliconazole (also registered as SKX-16) as a drug or biological intervention, as of the registry sync on 14 November 2026. Completed and withdrawn studies are not counted.

Are Luliconazole trials recruiting patients?

Yes. 1 of the 2 trials is recruiting: 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Luliconazole clinical trials?

SATO Pharmaceutical Co., Ltd (1) and Kafrelsheikh University (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Luliconazole works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Luliconazole works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Luliconazole (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 14 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.