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AboutPricing
Drug ReportsTirbanibulin
Klisyri(tirbanibulin)
Klisyri (tirbanibulin) is a small molecule pharmaceutical. Tirbanibulin was first approved as Klisyri on 2020-12-14. It has been approved in Europe to treat actinic keratosis.
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FDA Novel Drug Approvals 2020
Events Timeline
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Drug
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Safety
Events Timeline
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Klisyri
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tirbanibulin
Tradename
Company
Number
Date
Products
KLISYRIAlmirallN-213189 RX2020-12-14
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
klisyriNew Drug Application2024-11-08
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
TIRBANIBULIN, KLISYRI, ALMIRALL
2025-12-14NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Tirbanibulin, Klisyri, Almirall
106692362038-09-07DS, DP
106176932038-03-12U-3015
114977502038-03-12U-3015
78514702029-02-02DS, DPU-3015
103230012027-12-28DP
73009312026-02-06DS, DP
82367992025-12-28DS, DP
89808902025-12-28DS, DP
ATC Codes
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06B: Chemotherapeutics for topical use
— D06BX: Other chemotherapeutics in atc
— D06BX03: Tirbanibulin
HCPCS
No data
Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Actinic keratosisD055623—L57.0—14319
KeratosisD007642———14319
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTirbanibulin
INNtirbanibulin
Description
Tirbanibulin, sold under the brand name Klisyri, is a medication used for the treatment of actinic keratosis (AKs) on the face or scalp. It functions as a mitotic inhibitor by inhibiting tubulin polymerization and Src kinase signaling. It is potentially effective in deferring the development of AKs to squamous cell carcinoma in situ.
Classification
Small molecule
Drug classantineoplastics (mitotic inhibitors; tubulin binders)
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Structure (InChI/SMILES or Protein Sequence)
O=C(Cc1ccc(-c2ccc(OCCN3CCOCC3)cc2)cn1)NCc1ccccc1
Identifiers
PDB—
CAS-ID1038395-65-1
RxCUI—
ChEMBL IDCHEMBL571546
ChEBI ID—
PubChem CID23635314
DrugBankDB06137
UNII ID4V9848RS5G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 165 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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167 adverse events reported
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