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

212

Literatures (Medical) associated with Tavaborole

01 Feb 2025·Drug Development and Industrial Pharmacy

AQbD integrated high-performance thin layer chromatographic method for quantitative estimation of Tavaborole in the presence of its degradants and the matrix of nanostructured lipid carriers

Article

Author: Dave, Richa ; Vikas, Agrawal ; Patel, Rashmin ; Mrunali, Patel ; Neel, Savaliya ; Patel, Yash

BACKGROUNDTavaborole (TAV), a benzoxaborole derivative, is an FDA-approved antifungal agent for treating onychomycosis, a common and persistent fungal infection of the toenails.OBJECTIVEThis study aimed to develop a robust stability-indicating HPTLC method to determine TAV in nanostructured lipid carriers (NLC) using a comprehensive approach that includes risk assessment, and Analytical Quality by Design.METHODSThe critical method parameters influencing the HPTLC results were screened using a Plackett-Burman screening design followed by its optimization using a central composite optimization design. The developed method was validated as per ICH recommendation.RESULTSOptimized method utilized pre-coated aluminum-backed HPTLC plates using 10 µL/band injection volume, and the plate was developed using an isocratic mobile phase consisting of toluene: ethyl acetate: formic acid (75:25:1%v/v/v) in twin trough chamber pre-saturated for 20 mins with vapors of 10 mL of mobile phase. The separated components were detected at a wavelength of 221 nm. The developed HPTLC method resulted in a retardation factor of 0.49 ± 0.04 for TAV. Validation results revealed the HPTLC method's specificity (peak purity ≥ 0.999), linearity over a concentration range of 2-10 μg/band, sensitivity (LOD 0.21 μg and LOQ 0.64 μg), accuracy (99.68 - 101.43%w/w), and precision (%RSD < 2.0).CONCLUSIONThe developed robust stability-indicating HPTLC method was successfully implemented for the sustainable testing of the TAV in the NLC formulations and stability testing.

02 Jan 2025·ChemMedChem

α‐Triazolylboronic Acids: A Novel Scaffold to Target FLT3 in AML

Article

Author: Fini, Francesco ; Destro, Lorenza ; Crippa, Valentina ; Prati, Fabio ; Zambon, Alfonso ; Introvigne, Maria Luisa ; Zardi, Paolo ; Mologni, Luca ; Caselli, Emilia

AbstractThe treatment of acute myeloid leukemia (AML) presents a challenge to current therapies because of the development of drug resistance. Genetic mutation of FMS‐like tyrosine kinase‐3 (FLT3) is a target of interest for AML treatment, but the use of FLT3‐targeting agents on AML patients has so far resulted in poor overall clinical outcomes.[1] The incorporation of the boronic group in a drug scaffold could enhance the bioavailability and pharmacokinetic profile of conventional anticancer chemotypes. Boronic acids represent an intriguing and unexplored class of compounds in the context of AML, and they are only scantly reported as inhibitors of protein kinases. We identified α‐triazolylboronic acids as a novel chemotype for targeting FLT3 by screening a library of structurally heterogeneous in‐house boronic acids. Selected compounds show low micromolar activities on enzymatic and cellular assays, selectivity against control cell lines and a recurring binding mode in in‐silico studies. Furthermore, control analogues synthesized ad hoc and lacking the boronic acid are inactive, confirming that this group is essential for the activity of the series. All together, these results suggest α‐triazolylboronic acids could be a promising novel chemotype for FLT3 inhibition, laying the ground for the design of further compounds.

01 Dec 2024·Medical Mycology Case Reports

A case of refractory onychomycosis caused by Kloeckera apiculata: Successful treatment with itraconazole

Article

Author: Ehrlich-Fein, Samantha S ; Patel, Samir B. ; Ehrlich-Fein, Samantha S. ; Patel, Samir B

Here, we present the case of an otherwise healthy patient, without risk factors, who developed a refractory case of onychomycosis caused by Kloeckera apiculata, an uncommon human pathogen. The diagnosis was ultimately confirmed by fungal nail plate culture, histopathology, and PCR. Whereas prior treatments with topical 5 % tavaborole solution, oral terbinafine, and oral fluconazole were ineffective, complete clinical and mycological cure was achieved with a 3-month course of oral itraconazole.

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 R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Onychomycosis	Phase 3	United States	Anacor Pharmaceuticals LLC	07 Jul 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03405818 (Pubmed)	Phase 4	Onychomycosis	55	Tavaborole 5% Topical Solution	hkeoxtxkto(bgmgazadva) = isgdpoehds frmpvaanlo (rynmsdpdlm ) View more	-	01 Feb 2019
NCT03405818 (CTgov)	Phase 4	Onychomycosis	55	Kerydin	caybonujxw(inwjusnqbq) = xslvteebdy avjuccknot (swovahwtcm, vchnhxmgyw - eclxdoocvv) View more	-	17 Apr 2018
NCT01302119 (CTgov)	Phase 3	Onychomycosis	604	AN2690 Topical Solution, 5% (AN2690 Topical Solution, 5%)	vzciagfarh(hggzfmbiuo) = lcxvtzitgo kuirheiloh (gvpzzecbnb, tjojszspuw - imoxpoqduk) View more	-	15 Aug 2014
NCT01302119 (CTgov)	Phase 3	Onychomycosis	604	Solution Vehicle (Solution Vehicle)	vzciagfarh(hggzfmbiuo) = delrobipkr kuirheiloh (gvpzzecbnb, wshohlhvxf - dicrxztbjf) View more	-	15 Aug 2014
NCT01270971 (CTgov)	Phase 3	Onychomycosis	594	AN2690 Topical Solution, 5% (AN2690 Topical Solution, 5%)	swshukhiuy(uqpdzzgikr) = ubchfnvirl wvtcgtpwao (tdnqflukvk, qyotailcwl - zpbsywbivu) View more	-	15 Aug 2014
NCT01270971 (CTgov)	Phase 3	Onychomycosis	594	Solution Vehicle (Solution Vehicle)	swshukhiuy(uqpdzzgikr) = kkqkgkcinv wvtcgtpwao (tdnqflukvk, hdobvkjwkr - riuijugkip) View more	-	15 Aug 2014
NCT01278394 (CTgov)	Phase 2	Onychomycosis	29	AN2690	mhqvesnyxc(ymeqylvbsv) = gnkuugfxux trbgjkpktr (zvpxqlssoh, jgpggnslru - cfwlkwqavv) View more	-	15 Aug 2014

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