RANDOMIZED, DOUBLE BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED,PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OFFOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES 169.1 MG OF DR.REDDY’S LABORATORIES LIMITED WITH ITRACONAZOLE 200 MG INPATIENTS WITH ONYCHOMYCOSIS

Start Date10 Apr 2023

Sponsor / Collaborator

Dr. Reddy's Laboratories Ltd.

JPRN-jRCTs031220578 / CompletedNot ApplicableIIT

Efficacy of Fosravuconazole, an oral antifungal agent, in the treatment of tinea pedisAn exploratory study on short-term dosing

Start Date22 Feb 2023

Sponsor / Collaborator-

NCT03086226 / CompletedPhase 2IIT

A Randomized, Double Blind Phase II Proof-of-Concept Superiority Trial of Fosravuconazole 200 mg or 300 mg Weekly Dose Versus Itraconazole 400 mg Daily, All Three Arms in Combination With Surgery, in Patients With Eumycetoma in Sudan

This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined with surgery in subjects with eumycetoma in Sudan.
There will be three arms in this study: The first arm will be Fosravuconazole 300 mg weekly, the second arm will have Fosravuconazole 200 mg weekly and the control arm is the standard treatment using itraconazole 400mg daily.
At 3 months time-point, interim analysis will be done and one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity.

Start Date09 May 2017

Sponsor / Collaborator

Drugs for Neglected Diseases initiative

100 Clinical Results associated with Fosravuconazole L-Lysine Ethanolate

100 Translational Medicine associated with Fosravuconazole L-Lysine Ethanolate

100 Patents (Medical) associated with Fosravuconazole L-Lysine Ethanolate

Literatures (Medical) associated with Fosravuconazole L-Lysine Ethanolate

01 Nov 2024·The Lancet Infectious Diseases

Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial

Article

Author: Bahar, Mustafa El Nour ; Mhmoud, Najwa A ; Brüggemann, Roger J ; Hata, Katsura ; Zijlstra, Eduard E ; van de Sande, Wendy W J ; Mohamed, Abubakar Ahmed ; Bakhiet, Osama Elhadi ; Egondi, Thaddaeus W ; Chu, Wan-Yu ; Attalla, Hadil Yassir ; Fahal, Ahmed H ; Nyaoke, Borna A ; Onyango, Kevin O ; Mohamedelamin, El Semani Widaa ; Fahal, Lamis Ahmed ; Dorlo, Thomas P C ; Bakhiet, Sahar Mubarak ; Ahmed, Eiman Siddig ; Scherrer, Bruno ; Oyieko, Peelen ; Strub-Wourgaft, Nathalie ; Musa, Ahmed Mudawi ; Siddig, Emmanuel Edwar

BACKGROUNDEumycetoma is an implantation mycosis characterised by a large subcutaneous mass in the extremities commonly caused by the fungus Madurella mycetomatis. Despite the long duration of treatment, commonly a minimum of 12 months, treatment failure is frequent and can lead to amputation. We aimed to compare the efficacy of two doses of fosravuconazole, a synthetic antifungal designed for use in onychomycosis and repurposed for mycetoma, with standard-of-care itraconazole, both in combination with surgery.METHODSThis phase 2, randomised, double-blind, active-controlled, superiority trial was conducted in a single centre in Sudan. Patients with eumycetoma caused by M mycetomatis, who were aged 15 years or older, with a set lesion diameter (>2 cm and ≤16 cm) requiring surgery were included. There was a limit of 20 female patients in the initial enrolment, owing to preclinical toxicity concerns. Exclusion criteria included previous surgical or medical treatment for eumycetoma; presence of loco-regional lymphatic extension; osteomyelitis, or other bone involvement; pregnancy or lactation; severe concomitant diseases; a BMI under 16 kg/m²; contraindication to use of the study drugs; pre-existing liver disease; lymphatic extension; osteomyelitis; transaminase levels more than two times the laboratory's upper limit of normal, or elevated levels of alkaline phosphatase or bilirubin; or any history of hypersensitivity to any azole antifungal drug. Patients were randomly allocated in a 1:1:1 ratio to 300 mg fosravuconazole weekly for 12 months (group 1); 200 mg fosravuconazole weekly for 12 months (group 2); or 400 mg itraconazole daily for 12 months (group 3) using a random number list with non-disclosed fixed blocks of size 12, with equal allocation to each of the three arms within a block. To ensure masking between groups, placebo pills were used to disguise the difference in dosing schedules. All groups took pills twice daily with meals. In all groups, surgery was performed at 6 months. The primary outcome was complete cure at end of treatment at the month 12 visit, as evidenced by absence of mycetoma mass, sinuses, and discharge; normal ultrasonography or MRI examination of the eumycetoma site; and, if a mass was present, negative fungal culture from the former mycetoma site. The primary outcome was assessed in the modified intention-to-treat (mITT) population (all patients who received one or more treatment dose with one or more primary efficacy assessment). Safety was assessed in all patients who received one or more doses of the study drug. This study is registered with ClinicalTrials.gov (NCT03086226) and is complete.FINDINGSBetween May 9, 2017, and June 10, 2021, 104 patients were randomly allocated (34 in group 1 and 2, respectively, and 36 in group 3). 86 (83%) of 104 patients were male and 18 (17%) patients were female. After an unplanned second interim analysis, the study was terminated early for futility. Complete cure at 12 months in the mITT population was 17 (50%) of 34 (95% CI 32-68) for group 1, 22 (65%) of 34 (47-80) for group 2, and 27 (75%) of 36 (58-88) in group 3. Neither dose of fosravuconazole was superior to itraconazole (p=0·35 for 200 mg fosravuconazole vs p=0·030 for 300 mg fosravuconazole). 83 patients had a total of 205 treatment-emergent adverse events, and two patients had serious adverse events that led to discontinuation, neither related to treatment.INTERPRETATIONTreatment with either dose of fosravuconazole was not superior to itraconazole, and the two doses had a numerically lower efficacy. However, fosravuconazole presented no new safety signals, and its lower pill burden and reduced risk of drug-drug interactions compared with the relatively expensive and inaccessible itraconazole suggests further research into effective treatments with a shorter duration and higher cure rate, without the need for surgery are warranted.FUNDINGDrugs for Neglected Diseases initiative.

10 Sep 2024·The Journal of dermatology

Exploratory study on short-term administration of oral fosravuconazole for tinea pedis.

Article

Author: Naka, Wataru ; Tsunemi, Yuichiro

We investigated the clinical efficacy of short-term, oral fosravuconazole (F-RVCZ) therapy for tinea pedis, commonly known as athlete's foot. F-RVCZ (equivalent to 100 mg ravuconazole) was administered orally once daily for 1 week for interdigital and vesicular tinea pedis and for 4 weeks for hyperkeratotic tinea pedis. Efficacy was evaluated based on mycological efficacy and clinical symptoms at Weeks 1, 4, and 8 for interdigital and vesicular tinea pedis and at Weeks 4, 8, and 12 for hyperkeratotic tinea pedis. Efficacy was confirmed at the end of treatment. Therapeutic efficacy increased over time from the end of treatment for both types of tinea pedis. All adverse drug reactions (ADRs) were within expectations and there were no cases of discontinuation due to ADRs or serious ADRs. Short-term oral F-RVCZ therapy is expected to be as effective or more effective than terbinafine and itraconazole, which have already been approved in Japan and may be a useful option for the treatment of tinea pedis.

01 Sep 2024·The Journal of Dermatology

Impact of new antifungal medications on onychomycosis prescriptions and costs in Japan: A nationwide claims database study

Article

Author: Sato, Daisuke ; Yoshimura, Kensuke ; Sakamaki, Kentaro ; Togawa, Yaei ; Miyachi, Hideaki

AbstractOnychomycosis, a fungal nail infection, is a common dermatological condition in Japan, with a prevalence of approximately 5%–10%. Despite the introduction of new antifungal medications and updated treatment guidelines published in 2019, data on real‐world prescription trends and the associated medical costs are limited. This study aimed to investigate the prescription patterns and medical costs of topical and oral antifungal medications for onychomycosis in Japan from fiscal years 2014 to 2021 using the National Database of Health Insurance Claims and Specific Health Checkups of Japan Open Data. We analyzed the annual prescription volumes and medical costs of four antifungal medications: efinaconazole, luliconazole, fosravuconazole, and terbinafine. The prescription volume of efinaconazole, a topical medication launched in 2014, rapidly increased and dominated the market share. Fosravuconazole, an oral medication introduced in 2018, showed an increasing trend, coinciding with a decline in efinaconazole prescriptions. Terbinafine, a well‐established oral medication, experienced a substantial decrease in prescription volume. The sex‐ and age‐adjusted prescription volume per 100 000 population was higher among older adults, particularly for efinaconazole. The total medical costs for onychomycosis treatment more than doubled in fiscal year 2015 compared with that for 2014, mainly driven by efinaconazole prescriptions, and exceeded 30 billion Japanese yen in fiscal years 2019–2021. The costs slightly decreased in fiscal years 2020 and 2021, possibly due to the introduction of fosravuconazole. The predominance of topical prescriptions, especially in older adults, raises concerns regarding adherence to the Japanese guidelines that recommend oral antifungals as the first‐line treatment for onychomycosis. The substantial increase in medical costs also highlights the economic burden of onychomycosis and the need for cost‐effective treatment strategies. This study provides valuable insights into the real‐world prescription trends and medical costs of onychomycosis treatment in Japan, suggesting an opportunity to assess potential gaps between guideline recommendations and clinical practice.

News (Medical) associated with Fosravuconazole L-Lysine Ethanolate

18 Jul 2024

·www.echemi.com

Eisai and Sato Pharmaceutical Collaborate on Development of Novel Antifungal Drug Fosravuconazole in the Asia-Pacific

Eisai and Japan's Sato Pharmaceutical have announced a major collaboration, entering into a licensing agreement for the development and marketing rights of the novel antifungal drug Fosravuconazole (Fluxacom) in Asia and Oceania. Under this agreement, Eisai exclusively licenses the intellectual property rights for Fosravuconazole in the Asia and Oceania region to Sato Pharmaceutical. It should be pointed out that Fosravuconazole isa new antifungal drug independently developed by Eisai through its own research and development team, and its main active ingredient is ravuconazole. This innovative prodrug design improves the solubility of the drug while also significantly improving its bioavailability. Previously, Sato Pharmaceutical launched Fosravuconazole in the Japanese market in 2018 as an oral antifungal Nailin® for the treatment of onychomycosis such as nail fungal infections. This collaboration will undoubtedly accelerate the development and marketing of this innovative drug in the Asia-Pacific region. Under the terms of the agreement, Eisai will receive various financial benefits, including contract advances, sales milestone payments and royalties. Eisai also retains the right to develop and market medicines for the treatment of tinea pedis and other conditions related to it. Eisai expects to maximize the market value of Fosravuconazole in Asia/Oceania through this cooperation, and also hopes that this new drug can be applied to the clinic as soon as possible to provide a new treatment plan for patients with fungal infections. The two sides said that they will work together to promote the development and application of this innovative therapy, aiming to bring safer and more effective treatment options to the majority of patients, and help improve the health status and quality of life of patients.

License out/inDrug Approval

100 Deals associated with Fosravuconazole L-Lysine Ethanolate

External Link

KEGG	Wiki	ATC	Drug Bank
D10762	Fosravuconazole L-Lysine Ethanolate	D01BA	DB15204

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Onychomycosis	JP	Sato Pharmaceutical Co., Ltd.	19 Jan 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mycetoma	Preclinical	SD	Drugs for Neglected Diseases initiative	09 May 2017
Chagas Disease	Preclinical	BO	Drugs for Neglected Diseases initiative	01 Jun 2011
Chagas Disease	Preclinical	BO	Eisai Co., Ltd.	01 Jun 2011

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