Tirbanibulin is a Small Molecule owned by Athenex, and is involved in 23 clinical trials, of which 16 were completed, 6 are ongoing, and 1 is planned.

Tirbanibulin mesylate (KX01, KX2-391) inhibits Src kinase signaling and tubulin polymerization. Tubulin inhibitors act by perturbation of microtubule dynamics during the G2/M phase of cell division and subsequent entry into apoptosis. Src can be switched from an inactive to an active state through control of its phosphorylation state. Src kinase interacts with tyrosine kinase receptors, such as EGFR and the VEGF receptor and affect cell proliferation via the Ras/ERK/MAPK pathway. They regulate gene expression via transcription factors such as STAT molecules. SFKs can also affect cell adhesion and migration via interaction with integrins, actins, GTPase-activating proteins, scaffold proteins, such as p130(CAS) and paxillin, and kinases such as focal adhesion kinases. Inhibiting Src kinase, help in controlling malignant cell proliferation, angiogenesis, adhesion, invasion, motility, survival, and metastasis which may result in anti-cancer effect.

The revenue for Tirbanibulin is expected to reach a total of $2.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Tirbanibulin NPV Report.

Tirbanibulin is originated and owned by Athenex. Almirall is the other company associated in development or marketing of Tirbanibulin.

Tirbanibulin Overview

Tirbanibulin (Klisyri) acts as a anti-keratolytic agent. It is formulated as ointment for topical application. Klisyri is indicated for the treatment of actinic keratosis on the face or scalp. Klisyri is indicated for the treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis of the face or scalp in adults. Tirbanibulin (KX01, KX2-391) is under development for the treatment of acute myelocytic leukemia (AML), castration-resistant prostate cancer, actinic keratosis, psoriasis and solid tumors. It is administered orally and topically in the form of ointment and capsule. It is a small molecule and acts by targeting dual src/pretubulin. The drug candidate is based Mimetica and Optimized Photo-Affinity Labeling (Opal) platform. It was also under development for the treatment of breast cancer, skin cancers, liver fibrosis, gastric cancer, liquid tumor, ovarian cancer and hormone refractory (castration resistant, androgen-independent) prostate cancer, acute myelocytic leukemia (AML, acute myeloblastic leukemia), solid tumor and  lymphoma.

Almirall Overview

Almirall is a specialty pharmaceutical company that researches, develops, manufactures, and commercializes proprietary medicines and licensed products. The company’s major area of focus is dermatology covering psoriasis, eczema, acne, and other skin infections. It also develops products for autoimmune diseases including rheumatoid arthritis and multiple sclerosis; and gastrointestinal diseases including irritable bowel syndrome with constipation. The company also works together with small and medium-sized companies and healthcare professionals to develop medical solutions and provide them to patients. It operates through affiliates in Europe and Central America and has R&D centers in Spain and Germany. Almirall is headquartered in Barcelona, Spain.

The company reported revenues of (Euro) EUR827.2 million for the fiscal year ended December 2021 (FY2021), an increase of 2.4% over FY2020. In FY2021, the company’s operating margin was 0.7%, compared to an operating margin of 11.4% in FY2020. The net loss of the company was EUR40.9 million in FY2021, compared to a net profit of EUR74.3 million in FY2020. The company reported revenues of EUR197.2 million for the third quarter ended September 2022, a decrease of 54.8% over the previous quarter.

Quick View – Tirbanibulin

Report Segments
  • Innovator (NME)
Drug Name
  • Tirbanibulin
Administration Pathway
  • Oral
  • Topical
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Immunology
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.