An Open-label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Kerydin (Registered) (Tavaborole) Topical Solution, 5% In The Treatment Of Onychomycosis Of The Toenail In Pediatric Subjects Ages 6 To 16 Years And 11 Months

This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years).
Following confirmation of eligibility, including laboratory evidence of a fungal organism in the toenail, tavaborole topical solution was applied once daily to all affected toenails for a 48-week treatment period.
Clinical assessment of the extent of infection and safety assessments were performed periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after stopping the treatment).
A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small area of surrounding skin during the first 28 days. These subjects had blood samples analyzed to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical solution in children and adolescents.

Start Date22 Oct 2015

Sponsor / Collaborator

Pfizer Inc.

NCT01302119 / CompletedPhase 3

A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Start Date01 Feb 2011

Sponsor / Collaborator

Pfizer Inc.

NCT01270971 / CompletedPhase 3

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Start Date01 Dec 2010

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Tavaborole

100 Translational Medicine associated with Tavaborole

100 Patents (Medical) associated with Tavaborole

132

Literatures (Medical) associated with Tavaborole

01 Jan 2024·Mycoses

Retrospective analysis of onychomycosis prescribing patterns using the medicare part D prescribers database 2016–2020

Article

Author: Lipner, Shari R ; Roster, Katie ; Wang, Yu

Abstract:

Onychomycosis, defined as a fungal nail infection, affects 5.5% of the global population. Our objectives were to analyse prescription trends of onychomycosis medications using the Medicare Part D Prescribers database from 2016 to 2020, stratified by physician specialty. There was a 4% annual increase in the total cost of onychomycosis medications, with a notable decrease of 12.8% in 2020 during the COVID‐19 pandemic. Physicians demonstrated a strong consideration for price when selecting treatments, with the least expensive medications (ciclopirox and terbinafine) accounting for nearly 99% of all prescriptions. In contrast, the more costly medications (efinaconazole and tavaborole) were rarely prescribed. In addition, physicians often opted for the less costly generic versions of ciclopirox and itraconazole, prescribing them 99% and 91% of the time, respectively. Notably, physician assistants and nurse practitioners had higher overall increases in prescription rates, at 15%, compared to 1%–6% for other specialties. There are no recent United States onychomycosis guidelines, and our study emphasizes cost considerations when prescribing onychomycosis treatments.

01 Jan 2024·Mycoses

Treatment of onychomycosis in an era of antifungal resistance: Role for antifungal stewardship and topical antifungal agents

Review

Author: Guenin, Eric ; Joseph, Warren S ; Elewski, Boni ; Gupta, Aditya K ; Lipner, Shari R ; Daniel, C Ralph ; Ghannoum, Mahmoud ; Tosti, Antonella

Abstract:

A growing body of literature has marked the emergence and spread of antifungal resistance among species of Trichophyton, the most prevalent cause of toenail and fingernail onychomycosis in the United States and Europe. We review published data on rates of oral antifungal resistance among Trichophyton species; causes of antifungal resistance and methods to counteract it; and in vitro data on the role of topical antifungals in the treatment of onychomycosis. Antifungal resistance among species of Trichophyton against terbinafine and itraconazole—the two most common oral treatments for onychomycosis and other superficial fungal infections caused by dermatophytes—has been detected around the globe. Fungal adaptations, patient characteristics (e.g., immunocompromised status; drug–drug interactions), and empirical diagnostic and treatment patterns may contribute to reduced antifungal efficacy and the development of antifungal resistance. Antifungal stewardship efforts aim to ensure proper antifungal use to limit antifungal resistance and improve clinical outcomes. In the treatment of onychomycosis, critical aspects of antifungal stewardship include proper identification of the fungal infection prior to initiation of treatment and improvements in physician and patient education. Topical ciclopirox, efinaconazole and tavaborole, delivered either alone or in combination with oral antifungals, have demonstrated efficacy in vitro against susceptible and/or resistant isolates of Trichophyton species, with low potential for development of antifungal resistance. Additional real‐world long‐term data are needed to monitor global rates of antifungal resistance and assess the efficacy of oral and topical antifungals, alone or in combination, in counteracting antifungal resistance in the treatment of onychomycosis.

01 Sep 2023·Journal of drugs in dermatology : JDD

Individual Article: Updated Review of Topical Pharmaceuticals and Complementary and Alternative Medications for the Treatment of Onychomycosis in Both General and Special Populations in the United States.

Review

Author: Issa, Naiem T ; Kircik, Leon

Onychomycosis is a prevalent condition affecting the United States and global population. Treatment options are limited, with only 3 topical anti-fungal medications garnering approval in the US within the last 25 years: ciclopirox, tavaborole, and efinaconazole. The economic impact and quality of life burden due to onychomycosis are high. Here we provide an up-to-date review of all approved topical anti-fungal therapies for toenail onychomycosis. We discuss treatment efficacies, pharmacology, and use in special populations, as well as current evidence for complementary and alternative medicine. J Drugs Dermatol. 2023;22:9(Suppl 1):s5-10.

News (Medical) associated with Tavaborole

31 Jan 2024

·www.prnewswire.com

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis. Onychomycosis, or tinea unguium, is a fungal infection of the nail. Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the nail bed), and nail plate thickening. Onychomycosis accounts for one half of all nail disease with an estimated U.S. prevalence of up to 14%.1 In addition to cosmetic issues, onychomycosis infection may indirectly decrease peripheral circulation, thereby worsening conditions such as venous stasis and diabetic foot ulcers.2 "The initiation of clinical studies with VTR-297 in the treatment of onychomycosis is an important milestone in studying and developing potential new therapies for this common disorder," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor with activity against dermatophytes and fungi, originally isolated from the yeast species Streptomyces hygroscopicus as an antifungal antibiotic, first described in 1976.3 Current therapies for onychomycosis include topical agents JUBLIA® (efinaconzole), KERYDIN® (tavaborole), and PENLAC® (ciclopirox). There have not been any new onychomycosis treatments approved by the FDA since 2014.4 References Centers for Disease Control and Prevention. Fungal Nail Infections. Updated September 13, 2022. Accessed January 30, 2024. Available online: Scher, R. Onychomycosis: a significant medical disorder. J Am Acad Dermatol. 35, S2–5 (1996). Available online: (96)90061-4 Tsuji, N., Kobayashi, M., Nagashima, K., Wakisaka, Y., Koizumi, K. A New Antifungal Antibiotic, Trichostatin. J Antibiot (Tokyo). 1976 Jan;29(1):1-6. Available online: Markham, A. Tavaborole: First Global Approval. Drugs 74, 1555–1558 (2014). Available online: About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on Twitter @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to statements regarding the estimated prevalence of onychomycosis and the development of new antifungals, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the accuracy of the reporting and diagnosis of onychomycosis and onychomycosis cases and the ability to successfully complete the clinical development of, and obtain regulatory approval for, VTR-297 in the treatment of onychomycosis. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] SOURCE Vanda Pharmaceuticals Inc.

Drug ApprovalIND

26 Sep 2023

·www.biospace.com

AN2 Therapeutics Signs Grant Agreement to Discover Novel, Boron Based Therapies for Tuberculosis and Malaria

Grant from Bill & Melinda Gates Foundation MENLO PARK, Calif.--(BUSINESS WIRE)-- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced that it has received a research grant from the Bill & Melinda Gates Foundation to discover novel, boron containing small molecules for the treatment of tuberculosis and malaria. Funding from the Gates Foundation will support the discovery of novel inhibitors of aminoacyl-tRNA synthetases using AN2’s proprietary boron chemistry platform. AN2’s boron chemistry has the potential to address biological targets for tuberculosis and malaria that build on the scientific expertise of several AN2 scientists that were involved in discovering novel leucyl-tRNA synthetase inhibitors including epetraborole, tavaborole, as well as ganfeborole, which is currently in development for tuberculosis. AN2’s boron chemistry platform has demonstrated success against leucyl- tRNA synthetase, a target that has proven difficult to inhibit using traditional medicinal chemistry approaches. “Novel drugs that combat drug resistance and shorten therapy are urgently needed to reduce the impact of tuberculosis and malaria, diseases that are responsible for over 2 million deaths per year and disproportionately affect people in low- and middle-income countries,” said Eric Easom, Co-Founder, President and Chief Executive Officer of AN2 Therapeutics. “Our boron chemistry platform and team have a proven track record of delivering novel compounds targeting serious unmet needs in infectious diseases and global health that can be game-changers, and we are excited to engage in this important work. This grant underscores our commitment to address areas of high unmet need in global health and capture synergies with our existing research programs using non-dilutive funding.” About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (NTM) lung disease, a rare, chronic, and progressive infectious disease caused by bacteria known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the timing, progress, and anticipated results AN2's anticipated progress, business plans, business strategy and planned research efforts; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the continuing effects of the COVID-19 pandemic; macroeconomic conditions; early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidate; the significant uncertainty associated with AN2's product candidate ever receiving any regulatory approvals; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in AN2's reports to be filed with the SEC, including AN2’s Report on Form 10-Q for the quarter ended June 30, 2023. These filings, when available, are available on the investor relations section of our website at investor.an2therapeutics.com and on the SEC's website at . Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

31 Jul 2013

·www.biospace.com

Anacor Pharmaceuticals, Inc. to Host Investor Day in New York

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today! Anacor Pharmaceuticals (NASDAQ:ANAC) will host an Investor Day for institutional investors and research analysts on Monday August 5, 2013 from approximately 12:00 p.m. to 3:30 p.m. ET in New York, New York. The meeting will focus on the development of its two lead compounds - tavaborole for onychomycosis and AN2728 for atopic dermatitis. Experts in the fields of podiatry and dermatology will be featured speakers at the meeting. Hey, check out all the research scientist jobs. Post your resume today!

100 Deals associated with Tavaborole

External Link

KEGG	Wiki	ATC	Drug Bank
D10169	Tavaborole	D01AE24	DB09041

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Onychomycosis	US	Anacor Pharmaceuticals LLC	07 Jul 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03405818 (Pubmed)	Phase 4	Onychomycosis	55	Tavaborole 5% Topical Solution	ugglbcqyda(dfkqszkexw) = dicozhtdvo wpbvkrmkji (upahjqtuwk ) View more	-	01 Feb 2019
NCT03405818 (CTgov)	Phase 4	Onychomycosis	55	Kerydin	wwklqtndyo(vnpxkcfzti) = tnomfrjjty yvrnejqlky (tdxtyncmlv, xkduffyjlo - wkrotdfoqg) View more	-	17 Apr 2018
NCT01302119 (CTgov)	Phase 3	Onychomycosis	604	AN2690 Topical Solution, 5% (AN2690 Topical Solution, 5%)	gjfxgmrjup(gkyabgkppi): P-Value = <0.001 View more	-	15 Aug 2014
NCT01302119 (CTgov)	Phase 3	Onychomycosis	604	Solution Vehicle (Solution Vehicle)	gjfxgmrjup(gkyabgkppi): P-Value = <0.001 View more	-	15 Aug 2014
NCT01270971 (CTgov)	Phase 3	Onychomycosis	594	AN2690 Topical Solution, 5% (AN2690 Topical Solution, 5%)	adpgpystvi(iasufrabxn) = pkgszpyivc ksorpjczbv (fctahzhfvp, wdfnasicle - unyosgoyyz) View more	-	15 Aug 2014
NCT01270971 (CTgov)	Phase 3	Onychomycosis	594	Solution Vehicle (Solution Vehicle)	adpgpystvi(iasufrabxn) = ufemwvqjzq ksorpjczbv (fctahzhfvp, utywxvcypl - cepvakarwt) View more	-	15 Aug 2014
NCT01278394 (CTgov)	Phase 2	Onychomycosis	29	AN2690	sbqsvwtvts(qpzfbellep) = rheduxowbg zlvdchqxhb (mkmualnysf, qxlghvkmuk - buxgtayoag) View more	-	15 Aug 2014

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