10 completed, 2 recruiting, 1 active not recruiting, 1 not yet recruiting. 5 Phase 1, 4 Phase 2, 4 Phase 4, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 4, Unknown 1 |
| Phase 2 | 4 | Completed 2, Recruiting 1, Unknown 1 |
| Phase 4 | 4 | Completed 2, Active not recruiting 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 1, Not yet recruiting 1 |
Follow tirbanibulin: new trials by email Literature Review of tirbanibulin trials Research Report on tirbanibulin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead Cryotherapy + Tirbanibulin - Keratosis, Actinic Keratoses | Phase 3 | Not yet recruiting | University Hospital, Lille | 59 | 2026-11-30 | 2026-05-22 |
| Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR) Tirbanibulin - Actinic Keratosis (AK) | Recruiting | Avant Health LLC | 30 | 2026-04-02 | 2026-06-18 | |
| Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma Tirbanibulin - Cell Carcinoma | Phase 2 | Recruiting | Centre Hospitalier Universitaire de Nice | 50 | 2024-02-16 | 2026-06-22 |
| A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis Tirbanibulin, Vehicle ointment - Keratosis, Actinic | Phase 3 | Completed | Almirall, S.A. | 280 | 2023-12-21 | 2026-06-30 |
| Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Tirbanibulin - Actinic Keratoses | Phase 4 | Withdrawn | Medical University of Graz | 2023-10-01 | 2024-05-30 | |
| Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face Tirbanibulin - Actinic Keratosis | Phase 4 | Completed | Medical University of Graz | 22 | 2023-05-11 | 2023-11-14 |
| Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults Tirbanibulin Ointment 1% - Superficial Basal Cell Carcinoma | Phase 2 | Completed | Austin Institute for Clinical Research | 5 | 2023-04-17 | 2024-07-19 |
| A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses Tirbanibulin 2.5 mg ointment - Actinic Keratosis | Phase 4 | Completed | Almirall, S.A. | 334 | 2023-01-20 | 2025-02-20 |
| A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp Tirbanibulin (Klisyri®) 10 mg/g ointment, Diclofenac Sodium 3% Gel - Keratosis, Actinic | Phase 4 | Active not recruiting | Almirall, S.A. | 447 | 2022-10-24 | 2025-02-11 |
| Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis Tirbanibulin - Keratosis, Actinic | Completed | Almirall, S.A. | 300 | 2022-03-09 | 2024-09-20 | |
| KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis KX01 0.01% (0.1 mg/g), Placebo, KX01 0.1% (1.0 mg/g) - Psoriasis | Phase 1 | Completed | PharmaEssentia | 28 | 2015-10-27 | 2025-07-02 |
| Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML) KX2-391 - Acute Myelogenous Leukemia | Phase 1 | Completed | Kinex Pharmaceuticals Inc. | 24 | 2013-12-01 | 2015-12-07 |
| A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors KX2-391 and Paclitaxel - Unspecified Adult Solid Tumor, Protocol Specific, Gastric Cancer | Phase 1 / Phase 2 | Unknown | Hanmi Pharmaceutical Company Limited | 60 | 2012-12-01 | 2015-05-18 |
| Safety and Efficacy Study of KX2-391 for Treatment of Bone-Metastatic, Castration-Resistant Prostate Cancer KX2-391 - Bone-Metastatic, Castration-Resistant Prostate Cancer | Phase 2 | Completed | Athenex, Inc. | 31 | 2010-02-01 | 2023-02-02 |
| Evaluation of KX2-391 in Patients With Advanced Malignancies KX2-391 - Solid Tumors, Lymphoma | Phase 1 | Completed | Athenex, Inc. | 50 | 2007-11-01 | 2011-06-08 |
| KX2-391 in Treating Patients With Advanced Solid Tumors or Lymphoma That Did Not Respond to Treatment Src kinase inhibitor KX2-391, immunoenzyme technique, pharmacological study - Lymphoma, Lymphoproliferative Disorder | Phase 1 | Completed | Roswell Park Cancer Institute | 7 | 2007-10-01 | 2011-03-02 |
Keratosis, Actinic (8) · Keratosis (3) · Lymphoma (2) · Neoplasms (2) · Breast Neoplasms (1) · Burkitt Lymphoma (1) · Carcinoma (1) · Hodgkin Disease (1) · Immunoblastic Lymphadenopathy (1) · Intraocular Lymphoma (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Leukemia, Myeloid, Acute (1) · Lymphoma, B-Cell, Marginal Zone (1) · Lymphoma, Extranodal NK-T-Cell (1) · Lymphoma, Follicular (1)
Almirall, S.A. (4) · Athenex, Inc. (2) · Medical University of Graz (2) · Austin Institute for Clinical Research (1) · Avant Health LLC (1) · Centre Hospitalier Universitaire de Nice (1) · Hanmi Pharmaceutical Company Limited (1) · Kinex Pharmaceuticals Inc. (1) · PharmaEssentia (1) · Roswell Park Cancer Institute (1) · University Hospital, Lille (1)
United States (7) · Italy (3) · Spain (3) · France (2) · Germany (2) · Poland (2) · Austria (1) · Netherlands (1) · South Korea (1) · United Kingdom (1)
Alberto Lecchi (1) · Alex A. Adjei, MD, PhD (1) · Aung Naing, M.D. (1) · Edward Lain, MD, MBA (1) · James Thompson, MD (1) · Jin-Bon Hong, M.D. (1) · Michael Carducci, MD (1) · Min-Fun Rudolf Kwan, MD (1) · Po-Yuan Wu, M.D., Ph.D. (1) · Roger B Cohen, M.D. (1) · Seock-Ah Im, M.D., Ph.D. (1) · Siva Narayanan, PhD, MPhil, MHS, MSc (1) · Todd Schlesinger, MD (1)
PMID 35579731, PMID 36297594, PMID 39040844
2023 (1)