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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed actinic keratosis 3 milestones | |||||
| Filed | US (FDA) | Klisyri | actinic keratosis | 2020-03-09 | “the New Drug Application (NDA) for tirbanibulin, also known as ALM147891, for the treatment of actinic keratosis (AK), is sufficiently complete to permit a substantive review” almirall.com ↗ “Based on these data Almirall submitted a supplementary NDA in August 2023” almirall.com ↗ |
| Filed | EU (EMA) | — | actinic keratosis | 2020-03-02 | “the European Medicines Agency's (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for tirbanibulin” almirall.com ↗ |
| Filed | Other | — | actinic keratosis | — | “Almirall submitted for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic.” almirall.com ↗ “Almirall submitted Klisyri® for a marketing authorisation in Switzerland in December 2020” almirall.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 · 3 met primary | ||||||
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03285490 | Sep 2017 → May 2018 | actinic keratosis | Almirall, S.A. | Completed | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| 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 |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-09-17 | Almirall, S.A. | Results EADV 2025: Almirall advances skin science and leads innovation for holistic patient care in medical dermatology almirall.com ↗
The results show that tirbanibulin provides statistically significant and clinically meaningful reduction in AK lesion count compared to vehicle at day 57 while offering a favorable safety profile. |
| 2025-06-19 | Almirall, S.A. | Results Almirall shows efficacy of biologics with real-world evidence and new patient-centric research on psychological wellbeing at the 2025 International Congress of Dermatology almirall.com ↗ |
| 2024-06-10 | Almirall, S.A. | Regulatory FDA approves Almirall’s Klisyri® (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2 almirall.com ↗ |
| 2021-07-19 | Almirall, S.A. | Regulatory Almirall receives European Commission approval of Klisyri® ▼ (tirbanibulin), an innovative topical treatment for actinic keratosis almirall.com ↗
Almirall S.A. (BME: ALM) , a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults. |
| 2021-05-21 | Almirall, S.A. | Regulatory Almirall receives positive CHMP opinion for Klisyri®▼ (tirbanibulin), an innovative topical treatment for actinic keratosis almirall.com ↗ |
| 2021-02-11 | Almirall, S.A. | Results Almirall announces New England Journal of Medicine publication of Phase III data demonstrating efficacy and safety of Klisyri® (tirbanibulin) almirall.com ↗
Both Phase III studies, KX01-AK-003 and KX01-AK-004, met the primary endpoint, which was defined as 100% clearance of AK lesions at Day 57 within the face or scalp treatment areas, each study achieving a highly statistically significant result (p0.0 |
| 2020-12-15 | Almirall, S.A. | Regulatory Almirall announces FDA approval of Klisyri® (tirbanibulin), a new innovative topical treatment for actinic keratosis almirall.com ↗
Almirall, S.A. (BME:ALM) , a global biopharmaceutical company focused on skin health, announced today that Klisyri® (tirbanibulin) has been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of actinic keratosis (AK) of the face or scalp. |
| 2020-03-09 | Almirall, S.A. | Regulatory Almirall announces FDA acceptance for filing of U.S. New Drug Application (NDA) for tirbanibulin in actinic keratosis almirall.com ↗
Almirall, S.A. (ALM) announced today that the U.S. Food and Drug Administration (FDA) has completed its filing review and determined that the New Drug Application (NDA) for tirbanibulin, also known as ALM147891, for the treatment of actinic keratosis (AK), is sufficiently complete to permit a substantive review. |
| 2020-03-02 | Almirall, S.A. | Regulatory Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for tirbanibulin in actinic keratosis almirall.com ↗
Almirall, S.A. (ALM) today announced that the European Medicines Agency's (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis. |
| 2018-07-26 | Almirall, S.A. | Results Almirall announces that both phase III trials of KX2-391 for actinic keratosis achieved primary endpoint almirall.com ↗ |
All press releases naming this drug 14 releases
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 NCT01764087 ↗ |
| 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 ↗ |