Drugs / Tirbanibulin
Tirbanibulin
also known as
KX2-391 · KX01 · Klisyri · Klisyri (tirbanibulin ointment 1%) · KX-01 Mesylate · KX-01 METHANESULFONATE · KX2-391 MESYLATE · Tirbanibulin mesilate · +3 more
Small molecule targets SRC via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | KLISYRI | — | 2024-06-07 | fda.gov ↗ |
| Approved | EU (EMA) | Klisyri | — | 2021-07-16 | europa.eu ↗ |
| Approved | US (FDA) | KLISYRI | — | 2020-12-14 | fda.gov ↗ |
Trials 23 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT05245578 | Nov 2021 | — | PharmaEssentia | Completed | No outcome recorded |
| Phase 1 | NCT03575780 | Sep 2018 → Apr 2019 | actinic keratosis | Athenex, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05522816 | Oct 2015 → Mar 2021 | psoriasis | PharmaEssentia | Completed | No outcome recorded |
| Phase 1 | NCT02337205 | Dec 2014 → Mar 2016 | actinic keratosis | Athenex, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01397799 | Dec 2013 → Jul 2014 | acute myeloid leukemia | Kinex Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00658970 | Nov 2007 → Mar 2010 | cancer, lymphoma | Athenex, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00646139 | Oct 2007 → Aug 2008 | lymphoma, lymphoproliferative syndrome, small intestine cancer | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01764087 | Dec 2012 → Dec 2015 | breast cancer, cancer of unknown primary site, gastric cancer | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06112522 | Feb 2024 → Dec 2027 expected | carcinoma | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 2 | NCT05713760 | Apr 2023 → Mar 2024 | skin basal cell carcinoma | Austin Institute for Clinical Research | Completed | No outcome recorded |
| Phase 2 | NCT02838628 | Apr 2016 → Jan 2017 | actinic keratosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01074138 | Feb 2010 → Jun 2012 | castration-resistant prostate carcinoma | Athenex, Inc. | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07273656 | Nov 2026 → Nov 2028 expected | actinic keratosis, keratosis | University Hospital, Lille | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06135415 | Dec 2023 → Apr 2025 | actinic keratosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05279131 | Jun → Dec 2022 | actinic keratosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05231044 | Dec 2021 → Nov 2023 | actinic keratosis | PharmaEssentia | Completed | No outcome recorded |
| Phase 3 | NCT03285477 | Sep 2017 → May 2018 | actinic keratosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT03285490 | Sep 2017 → May 2018 | actinic keratosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06791525 | May 2025 → Nov 2026 expected | common wart | The Skin Center Dermatology Group | Recruiting | No outcome recorded |
| Phase 4 | NCT06026358 | Oct 2023 → Dec 2024 | actinic keratosis | Medical University of Graz | Withdrawn | No outcome recorded |
| Phase 4 | NCT05900258 | May → Nov 2023 | actinic keratosis | Medical University of Graz | Completed | No outcome recorded |
| Phase 4 | NCT05741294 | Jan 2023 → Jan 2024 | actinic keratosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 4 | NCT05387525 | Oct 2022 → Jul 2027 expected | actinic keratosis | Almirall, S.A. | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07010692 Comparator | May 2025 → May 2030 expected | basal cell carcinoma, epithelial skin neoplasm, skin cancer, squamous cell carcinoma | Bruce Robinson, MD | Recruiting | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tirbanibulin | “This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 (Tirbanibulin Ointment) in the treatment of...” NCT05522816 ↗13“The tubulin polymerization and Src kinase signaling inhibitor tirbanibulin is being investigated as a topical treatment for actinic keratosis” PMID 33567191 ↗ Feb 2021 “Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results.” PMID 33196758 ↗ Nov 2020 |
| Known as | Klisyri | “Klisyri® 10 mg/g Ointment (Tirbanibulin) patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC.” NCT05900258 ↗1“Tirbanibulin (Klisyri®)” NCT05279131 ↗ |
| Known as | Klisyri (tirbanibulin ointment 1%) | “Klisyri (tirbanibulin ointment 1%)” NCT05713760 ↗ |
| Known as | KX-01 Mesylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Known as | KX-01 METHANESULFONATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Known as | KX01 | “This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 (Tirbanibulin Ointment) in the treatment of...” NCT05522816 ↗3“Tirbanibulin (KX01) is a new Src kinase inhibitor with potent antiproliferative activity against keratinocytes and has been approved for treatment of actinic keratosis.” PMID 36297594 ↗ Oct 2022 |
| Known as | KX2-391 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01397799 ↗ |
| Known as | KX2-391 MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Known as | Tirbanibulin mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Known as | TIRBANIBULIN MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Known as | Tirbanibulina | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Known as | Tirbanibuline | ChEMBL registry synonym — accepted as the source's own label CHEMBL571546 ↗ |
| Action | Inhibit | “Src kinase inhibitor KX2-391” NCT00646139 ↗ |
| Modality | Small molecule | — CHEMBL571546 ↗ |
| Route | Oral | “Patients receive oral KX2-391 once or twice daily for 3 weeks.” NCT00646139 ↗ |
| Target | SRC | “Src kinase inhibitor KX2-391” NCT00646139 ↗ |