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
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 |
|---|---|---|---|---|
| KLISYRI | Almirall | N-213189 RX | 2020-12-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| klisyri | New Drug Application | 2020-12-18 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TIRBANIBULIN, KLISYRI, ALMIRALL | |||
| 2025-12-14 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 3 | 1 | — | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 1 | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | 1 | — | — | — | 1 | ||
| Basal cell carcinoma | D002280 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | 2 | — | — | — | — | 2 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TIRBANIBULIN |
| INN | tirbanibulin |
| 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 class | antineoplastics (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-ID | 897016-82-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL571546 |
| ChEBI ID | — |
| PubChem CID | 23635314 |
| DrugBank | DB06137 |
| UNII ID | 4V9848RS5G (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:
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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
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459 adverse events reported
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