tavaborole

Trade name: kerydin

Small moleculeapproved

Approved

Jul 7, 2014

Tavaborole is a boron-based pharmaceutical agent indicated for the topical treatment of toenail onychomycosis, a fungal infection of the nail and nail bed due to Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole acts by inhibiting an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS) - Leucyl-tRNA synthetase. Leucyl-tRNA synthetase is an essential fungal enzyme required for protein synthesis and for the catalysis of ATP-dependent ligation of L-leucine to tRNA(Leu). Tavaborole’s low molecular weight (approximately half of most antifungals, such as terbinafine and efinaconazole) permits optimal nail plate penetration, superior to that of existing topical antifungal medications. — NCATS

Clinical trial activity

11 trials · 1 clinical orgs · 13 marketing orgs

Phase 1
3
Phase 2
9
Phase 3
2
Phase 4
1

Earliest trial started Nov 1, 2005 (NCT00679523)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Jul 7, 2014

    Anacor — Earliest FDA Approval

  3. Jul 7, 2014

    Anacor — NDA Organization

2020s

  1. Oct 13, 2020

    Encube Ethicals Pvt. Ltd. — Marketing Organization

  2. Oct 13, 2020

    Perrigo — Marketing Organization

  3. Oct 13, 2020

    Padagis Us — Marketing Organization

  4. Oct 21, 2020

    Alembic — Marketing Organization

  5. Nov 25, 2020

    Amneal Pharmaceuticals — Marketing Organization

  6. Feb 3, 2021

    Chartwell Pharmaceuticals — Marketing Organization

  7. Feb 3, 2021

    Identirx — Marketing Organization

  8. Feb 8, 2021

    Lupin — Marketing Organization

  9. Feb 9, 2021

    Cipla — Marketing Organization

  10. May 7, 2021

    Taro Pharmaceuticals — Marketing Organization

  11. May 7, 2021

    Sun Pharmaceuticals — Marketing Organization

  12. Apr 10, 2023

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedJul 7, 2014

Chemistry & pharmacology

Loading structure…

SMILES

OB1OCC2=C1C=CC(F)=C2
Mol. weight
151.931 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

First in class

Sources

Also known as

  • 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole
  • 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole
  • 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole
  • 5-fluoro-2,1-benzoxaborol-1(3h)-ol
  • 5-fluoro-2,1-benzoxaborol-1(3h)-ol
  • an2690
  • an2690
  • an2690
  • an2690
  • an 2690
  • an 2690
  • an-2690
  • an-2690
  • an-2690
  • an-2690
  • an-2690
  • an-2690
  • kerydin
  • kerydin
  • kerydin
  • kerydin
  • tavaborole
  • tavaborole
  • tavaborole
  • tavaborole
  • tavaborole
  • tavaborole
  • tavaborole
  • tavaborole
  • tavaborole

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03405818Phase 4Oct 22, 2015Pfizer
NCT01302119Phase 3Feb 1, 2011Pfizer
NCT01270971Phase 3Dec 1, 2010Pfizer
NCT01278394Phase 2Mar 1, 2007Pfizer
NCT00679601Phase 1/Phase 2 (Phase 2)Mar 1, 2007Pfizer
NCT00680095Phase 1Jan 1, 2007Pfizer
NCT00680134Phase 2Jun 1, 2006Pfizer
NCT00679770Phase 2Jun 1, 2006Pfizer
NCT00680160Phase 1/Phase 2 (Phase 2)Apr 1, 2006Pfizer
NCT00679965Phase 2Feb 1, 2006Pfizer
NCT00679523Phase 2Nov 1, 2005Pfizer
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit111142005
1 organizations
Page 1 / 1

Marketing (17)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGOct 21, 2020
AlembicFor profitSYNOct 21, 2020
Amneal PharmaceuticalsFor profitMKTGNov 25, 2020
AnacorFor profitNDAJul 7, 2014
AnacorFor profitSYNJul 7, 2014
Chartwell PharmaceuticalsFor profitMKTGFeb 3, 2021
CiplaFor profitMKTGFeb 9, 2021
Encube Ethicals Pvt. Ltd.For profitMKTGOct 13, 2020
IdentirxFor profitMKTGFeb 3, 2021
LupinFor profitMKTGFeb 8, 2021
Padagis UsFor profitMKTGOct 13, 2020
PerrigoFor profitMKTGOct 13, 2020
Sun PharmaceuticalsFor profitMKTGMay 7, 2021
Taro PharmaceuticalsFor profitSYNMay 7, 2021
Taro PharmaceuticalsFor profitMKTGNov 19, 2019
Taro PharmaceuticalsFor profitMKTGMay 7, 2021
Zydus Discovery DMCCFor profitMKTGApr 10, 2023