Drugs / Tavaborole
Tavaborole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | KERYDIN | — | 2018-07-30 | fda.gov ↗ |
| Approved | US (FDA) | KERYDIN | — | 2014-07-07 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00680095 | Jan → Feb 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT00679601 | Mar → May 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01278394 | Mar 2007 → Jul 2008 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00679770 | Jun 2006 → Aug 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00680134 | Jun 2006 → Aug 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00680160 | Apr 2006 → May 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00679965 | Feb 2006 → Jul 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00679523 | Nov 2005 → Feb 2007 | tinea unguium | Pfizer | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT01302119 | Feb 2011 → Dec 2012 | fungal infection of the toenail | Pfizer | Completed | Met primary |
| Phase 3 | NCT01270971 | Dec 2010 → Nov 2012 | fungal infection of the toenail | Pfizer | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03405818 | Oct 2015 → Jul 2017 | tinea unguium | Pfizer | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-04-11 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Tavaborole Topical Solution, 5% zyduslife.com ↗ |
| 2021-07-13 | Lupin Limited | Lupin Launches Tavaborole Topical Solution in the United States lupin.com ↗ |
| 2021-02-09 | Lupin Limited | Lupin Receives Approval for Tavaborole Topical Solution lupin.com ↗ |
| 2018-10-29 | Perrigo Company | Perrigo Confirms Patent Challenge For Generic Version Of Kerydin® perrigo.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tavaborole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03405818 ↗ |
| Known as | AN2690 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00680134 ↗ |
| Known as | Kerydin | ChEMBL registry synonym — accepted as the source's own label CHEMBL443052 ↗ |
| Known as | SCH 900340 | ChEMBL registry synonym — accepted as the source's own label CHEMBL443052 ↗ |
| Known as | Tavaborol | ChEMBL registry synonym — accepted as the source's own label CHEMBL443052 ↗ |
| Modality | Small molecule | — CHEMBL443052 ↗ |
| Route | Topical | “Topically Applied AN2690 5.0% and 7.5% Solution” NCT00679523 ↗ |