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    DRUG:

    Klisyri (tirbanibulin ointment)

    i
    Other names: KX-01 topical, KX2-391 topical, KX01 topical, ALM-14789, ALM14789
    Associations

    News

    Trials
    Company:
    Almirall, Athenex, Guangzhou Xiangxue Pharma, PharmaEssentia
    Drug class:
    Src kinase inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov)
    P3, N=280, Completed, Almirall, S.A. | Active, not recruiting --> Completed | Trial completion date: Nov 2026 --> Apr 2025 | Trial primary completion date: Apr 2026 --> Apr 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Klisyri (tirbanibulin ointment)
    7ms
    Tirbanibulin for Pediatric Warts (clinicaltrials.gov)
    P4, N=10, Recruiting, The Skin Center Dermatology Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Klisyri (tirbanibulin ointment)
    10ms
    TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov)
    P3, N=280, Active, not recruiting, Almirall, S.A. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Klisyri (tirbanibulin ointment)
    10ms
    A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp (clinicaltrials.gov)
    P4, N=447, Active, not recruiting, Almirall, S.A. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Klisyri (tirbanibulin ointment)
    10ms
    TirbAKare: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov)
    P3, N=270, Recruiting, Almirall, S.A. | Trial completion date: Dec 2024 --> Nov 2026 | Trial primary completion date: Dec 2024 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    Klisyri (tirbanibulin ointment)
    11ms
    Tirbanibulin for Pediatric Warts (clinicaltrials.gov)
    P4, N=10, Not yet recruiting, The Skin Center Dermatology Group
    New P4 trial
    |
    Klisyri (tirbanibulin ointment)
    1year
    TIRBASKIN: A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses (clinicaltrials.gov)
    P4, N=342, Completed, Almirall, S.A. | Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
    Trial completion date • Trial primary completion date
    |
    Klisyri (tirbanibulin ointment)
    over1year
    Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults (clinicaltrials.gov)
    P2, N=5, Completed, Austin Institute for Clinical Research | Recruiting --> Completed | N=10 --> 5
    Trial completion • Enrollment change
    |
    Klisyri (tirbanibulin ointment)
    over1year
    Tirbanibulin decreases cell proliferation and downregulates protein expression of oncogenic pathways in human papillomavirus containing HeLa cells. (PubMed, Arch Dermatol Res)
    Tirbanibulin 1% ointment is a synthetic antiproliferative agent approved in 2021 by the European Union for treating actinic keratoses (AK). These results demonstrate that tirbanibulin may impact expression of HPV oncoproteins via the Src- MEK- pathway. Tirbanibulin significantly downregulates oncogenic proteins related to cell cycle regulation and cell proliferation while upregulating apoptosis pathways.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1) • E2F1 (E2F transcription factor 1) • RBL2 (RB Transcriptional Corepressor Like 2)
    |
    Klisyri (tirbanibulin ointment) • tirbanibulin oral (KX-01 oral)
    over1year
    Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands (clinicaltrials.gov)
    P4, N=0, Withdrawn, Medical University of Graz | N=30 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Klisyri (tirbanibulin ointment)
    over1year
    A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (clinicaltrials.gov)
    P3, N=270, Recruiting, Almirall, S.A. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Klisyri (tirbanibulin ointment)
    over1year
    A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp (clinicaltrials.gov)
    P3, N=108, Completed, PharmaEssentia | Active, not recruiting --> Completed
    Trial completion
    |
    Klisyri (tirbanibulin ointment)