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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
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 Application2020-12-18
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
19 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Actinic keratosisD055623L57.0214119
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80313
Breast neoplasmsD001943EFO_0003869C50111
Stomach neoplasmsD013274EFO_0003897C16111
Castration-resistant prostatic neoplasmsD06412911
Basal cell carcinomaD00228011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.922
Myeloid leukemia acuteD015470C92.011
Lymphoproliferative disordersD008232Orphanet_2442D47.911
Healthy volunteers/patients11
PsoriasisD011565EFO_0000676L4011
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 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 can be potentially effective in deferring the development of AKs to squamous cell carcinoma in situ.
Classification
Small molecule
Drug classantineoplastics (mitotic inhibitors; tubulin binders)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(Cc1ccc(-c2ccc(OCCN3CCOCC3)cc2)cn1)NCc1ccccc1
Identifiers
PDB
CAS-ID897016-82-9
RxCUI
ChEMBL IDCHEMBL571546
ChEBI ID
PubChem CID23635314
DrugBankDB06137
UNII ID4V9848RS5G (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 78 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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459 adverse events reported
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