Skip to main content
SpringerLink
Log in

Tavaborole: First Global Approval

  • R & D INSIGHT REPORT
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Tavaborole is a novel, low-molecular weight oxaborole antifungal drug under development by Anacor Pharmaceuticals Inc. for the topical treatment of onychomycosis of the toenail. The drug has received its first global approval for this indication in the US. This article summarizes the milestones in the development of tavaborole leading to this first approval for onychomycosis of the toenails.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Elewski B, Pariser D, Rich P, et al. Current and emerging options in the treatment of onychomycosis. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S9–12.

    PubMed  Google Scholar 

  2. Anacor Pharmaceuticals Inc. FDA approves Anacor Pharmaceuticals KERYDINTM (tavaborole) topical solution, 5 % for the treatment of onychomycosis of the toenails [media release]. 2014. http://investor.anacor.com/releasedetail.cfm?ReleaseID=858211.

  3. Anacor Pharmaceuticals Inc. Tavaborole KERYDINTM (tavaborole): US prescribing information. 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204427s000lbl.pdf. Accessed 24 Jul 2014.

  4. Anacor Pharmaceuticals Inc. Anacor regains worldwide rights to AN2690 from Merck. [media release]. 2010. http://investor.anacor.com/releasedetail.cfm?ReleaseID=527619.

  5. Rock FL, Mao W, Yaremchuk A, et al. An antifungal agent inhibits an aminoacyl-tRNA synthetase by trapping tRNA in the editing site. Science. 2007;316(5832):1759–61.

    Article  CAS  PubMed  Google Scholar 

  6. Sanders V, Baker S, Alley M. Microbiological activity of AN2690, a new antifungal agent in development for the topical treatment of onychomycosis [poster]. 2006. http://www.anacor.com/pdf/AAD_P1608.pdf. Accessed 6 Aug 2014.

  7. Hui X, Baker SJ, Wester RC, et al. In vitro penetration of a novel oxaborole antifungal (AN2690) into the human nail plate. J Pharm Sci. 2007;96(10):2622–31.

    Article  CAS  PubMed  Google Scholar 

  8. Elewski BE, Tosti A. Tavaborole for the treatment of onychomycosis. Expert Opin Pharmacother. 2014;15(10):1439–48.

    Article  CAS  PubMed  Google Scholar 

  9. Beutner K, Sanders V, Hold K. An open-label, multiple-dose study of the absorption and systemic pharmacokinetics of AN2690 applied as a 7.5 % solution to all toenails of adult patients with moderate to severe onychomycosis. J Am Acad Dermatol. 2007;56(2 Suppl 2):129.

    Google Scholar 

  10. Dosik J, Lastella P, Yavel R, et al. The pharmacokinetics of AN2690 after topical application in patients with onychomycosis. J Invest Dermatol. 2011;131:S47.

    Google Scholar 

  11. Elewski BE, Rich P, Wiltz H, et al. Effectiveness and safety of tavaborole, a novel boron-based molecule for the treatment of onychomycosis: results from two phase 3 studies [poster]. In: 10th Annual High Risk Diabetic Foot Conference, Phoenix, 20–22 Nov 2013.

  12. Toledo Bahena M, Gomez JB, Zane L, et al. Safety and efficacy of tavaborole (AN2690), a novel boron-based molecule, in 3 phase II trials for the topical treatment of toenail onychomycosis. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB92.

    Google Scholar 

  13. Zane L, Pollak R. Safety and efficacy of tavaborole (formerly AN2690), a novel boron-based molecule, in phase 2 trials for the topical treatment of toenail onychomycosis [poster no. P1608]. In: 100th National American Podiatric Medical Association, Washington DC, 16–19 August 2012.

Download references

Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Anthony Markham

Authors
  1. Anthony Markham
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Anthony Markham.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Markham, A. Tavaborole: First Global Approval. Drugs 74, 1555–1558 (2014). https://doi.org/10.1007/s40265-014-0276-7

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-014-0276-7

Keywords

Search

Navigation