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

139

Literatures (Medical) associated with Tavaborole

01 Sep 2024·International Journal of Antimicrobial Agents

Development of an effective meropenem/KPC-2 inhibitor combination to combat infections caused by carbapenem-resistant Klebsiella pneumoniae

Article

Author: Tang, Yang ; Peng, Mingxiu ; Xu, Yating ; Liu, Chenyu ; Chen, Sheng ; Chan, Edward Wai-Chi ; Yang, Chen

The global public health threat of antibiotic resistance continues to escalate, and necessitates the implementation of urgent measures to expand the arsenal of antimicrobial drugs. This study identified a benzoxaborane compound, namely 5-chloro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole (AN2178), which can inhibit the catalytic activity of the Klebsiella pneumoniae carbapenemase (KPC-2) enzyme effectively. The efficacy of AN2718 as an inhibitor for the KPC-2 enzyme was verified through various assays, including enzyme activity assays and isothermal titration calorimetry. Results of multiple biochemical assays, minimum inhibitory concentration assays and time-killing assays also showed that binding of AN2718 to KPC-2 enabled restoration of the bactericidal effect of meropenem. The survival rate of mice infected with carbapenem-resistant, high-virulence strains increased significantly upon treatment with AN2718. Most importantly, the meropenem and AN2718 combination was effective on KPC-2 mutations such as KPC-33, which evolved clinically and exhibited resistance to ceftazidime-avibactam after clinical use for a couple of years. Comprehensive safety tests both in vitro and in vivo, such as cytotoxicity, haemolytic activity and cytochrome P450 inhibition assays, demonstrated that AN2718 was safe for clinical use. These promising data indicate that AN2718 has high potential for approval for the treatment of drug resistant-bacterial infections, including those caused by ceftazidime-avibactam-resistant strains. AN2718 can be regarded as a valuable addition to the current antimicrobial armamentarium, and a promising tool to combat antimicrobial resistance.

01 Aug 2024·Computational Biology and Chemistry

Computational therapeutic repurposing of tavaborole targeting arginase-1 for venous leg ulcer

Article

Author: Kumar V, Naveen ; Tamilanban, T

Venous leg ulcers (VLUs) pose a growing healthcare challenge due to aging, obesity, and sedentary lifestyles. Despite various treatments available, addressing the complex nature of VLUs remains difficult. In this context, this study investigates repurposing boronated drugs to inhibit arginase 1 activity for VLU treatment. The molecular docking study conducted by Schrodinger GLIDE targeted the binuclear manganese cluster of arginase 1 enzyme (2PHO). Further, the ligand-protein complex was subjected to molecular dynamic studies at 500 ns in Gromacs-2019.4. Trajectory analysis was performed using the GROMACS simulation package of protein RMSD, RMSF, RG, SASA, and H-Bond. The docking study revealed intriguing results where the tavaborole showed a better docking score (-3.957 Kcal/mol) compared to the substrate L-arginine (-3.379 Kcal/mol) and standard L-norvaline (-3.141 Kcal/mol). Tavaborole interaction with aspartic acid ultimately suggests that the drug molecule binds to the catalytic site of arginase 1, potentially influencing the enzyme's function. The dynamics study revealed the compounds' stability and compactness of the protein throughout the simulation. The RMSD, RMSF, SASA, RG, inter and intra H-bond, PCA, FEL, and MMBSA studies affirmed the ligand-protein and protein complex flexibility, compactness, binding energy, van der waals energy, and solvation dynamics. These results revealed the stability and the interaction of the ligand with the catalytic site of arginase 1 enzyme, triggering the study towards the VLU treatment.

14 Mar 2024·ACS Medicinal Chemistry Letters

Design, Synthesis, and Antifungal Activity of 3-Substituted-2(5H)-Oxaboroles

Article

Author: Szwetkowski, Connor ; Truong, Mindy ; Santos, Webster L ; Piedl, Karla ; Buchbinder, Nicklas W ; Campbell, Rose ; Mevers, Emily ; Matson, John B ; Zhu, Yumeng

Next generation antimicrobial therapeutics are desperately needed as new pathogens with multiple resistance mechanisms continually emerge. Two oxaboroles, tavaborole and crisaborole, were recently approved as topical treatments for onychomycosis and atopic dermatitis, respectively, warranting further studies into this privileged structural class. Herein, we report the antimicrobial properties of 3-substituted-2(5H)-oxaboroles, an unstudied family of medicinally relevant oxaboroles. Our results revealed minimum inhibitory concentrations as low as 6.25 and 5.20 μg/mL against fungal (e.g., Penicillium chrysogenum) and yeast (Saccharomyces cerevisiae) pathogens, respectively. These oxaboroles were nonhemolytic and nontoxic to rat myoblast cells (H9c2). Structure-activity relationship studies suggest that planarity is important for antimicrobial activity, possibly due to the effects of extended conjugation between the oxaborole and benzene rings.

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03405818 (Pubmed)	Phase 4	Onychomycosis	55	Tavaborole 5% Topical Solution	zxsnfcbgfq(vfpwoejpms) = attawtbcyt egkluoqbxx (zmttilktrd ) View more	-	01 Feb 2019
NCT03405818 (CTgov)	Phase 4	Onychomycosis	55	Kerydin	vhspahczfy(pgzisknniu) = sdsgxdwesj ukgpkvfabo (sokiimxfdx, sibiwpytjo - agxtjtjvbo) View more	-	17 Apr 2018
NCT01302119 (CTgov)	Phase 3	Onychomycosis	604	AN2690 Topical Solution, 5% (AN2690 Topical Solution, 5%)	mzselqqjdx(qlylljihif) = zbztncutnb odvdorpcku (byaurinqnw, nksfqjfepq - ynytocqzyo) View more	-	15 Aug 2014
NCT01302119 (CTgov)	Phase 3	Onychomycosis	604	Solution Vehicle (Solution Vehicle)	mzselqqjdx(qlylljihif) = cqgioszdjq odvdorpcku (byaurinqnw, purfoswxzb - zvukqycyuh) View more	-	15 Aug 2014
NCT01270971 (CTgov)	Phase 3	Onychomycosis	594	AN2690 Topical Solution, 5% (AN2690 Topical Solution, 5%)	dzfabzzfol(qjdffejque) = giyypjvlnv dkkmfkvmgm (riorjbibne, shitwnktvo - oguwcynvky) View more	-	15 Aug 2014
NCT01270971 (CTgov)	Phase 3	Onychomycosis	594	Solution Vehicle (Solution Vehicle)	dzfabzzfol(qjdffejque) = zudevvpjiz dkkmfkvmgm (riorjbibne, yejsspsyfv - yjbnmzelyg) View more	-	15 Aug 2014
NCT01278394 (CTgov)	Phase 2	Onychomycosis	29	AN2690	ybgoljyyqe(tpomrsygtd) = ktypvsthgm rhirhsksnt (tyykxxaqrz, pjekjmvtar - ysayptcbvx) View more	-	15 Aug 2014

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