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Halaven(eribulin)
Halaven (eribulin) is a small molecule pharmaceutical. Eribulin was first approved as Halaven on 2010-11-15. It is used to treat breast neoplasms and liposarcoma in the USA. It has been approved in Europe to treat breast neoplasms and liposarcoma. The pharmaceutical is active against tubulin beta chain.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Halaven
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eribulin mesylate
Tradename
Company
Number
Date
Products
HALAVENEisaiN-201532 RX2010-11-15
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
halavenNew Drug Application2022-12-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
liposarcoma—D008080—
Agency Specific
FDA
EMA
Expiration
Code
ERIBULIN MESYLATE, HALAVEN, EISAI INC
2026-03-13PED
2025-09-13M-280
2023-01-28ODE-107
Patent Expiration
Patent
Expires
Flag
FDA Information
Eribulin Mesylate, Halaven, Eisai Inc
RE469652027-01-08DP
62148652023-07-20DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XX: Other antineoplastic agents in atc
— L01XX41: Eribulin
HCPCS
Code
Description
J9179
Injection, eribulin mesylate, 0.1 mg
Clinical
Clinical Trials
174 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5017561641395
Male breast neoplasmsD018567—1—1—2
Drug-related side effects and adverse reactionsD064420T88.7———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD0647267143——22
SarcomaD012509371—110
Non-small-cell lung carcinomaD002289341——7
Urethral neoplasmsD014523EFO_0003846—21——3
Ureteral neoplasmsD014516EFO_0003844C66—21——3
Pelvic neoplasmsD010386—11——2
Neoplasm metastasisD009362EFO_0009708—11——2
Urologic neoplasmsD014571C64-C68111——2
Urinary bladder neoplasmsD001749C67111——2
Invasive hydatidiform moleD002820D39.2——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80223———23
Ovarian neoplasmsD010051EFO_0003893C5632———5
Inflammatory breast neoplasmsD05892213———3
Prostatic neoplasmsD011471C6112———3
LiposarcomaD00808022———3
Fallopian tube neoplasmsD00518511———2
Brain neoplasmsD001932EFO_0003833C7111———2
Ewing sarcomaD012512EFO_000017312———2
LeiomyosarcomaD00789012———2
Ovarian epithelial carcinomaD00007721611———2
Show 12 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal cell carcinomaD0022921————1
Lung neoplasmsD008175C34.901————1
MelanomaD0085451————1
Abdominal neoplasmsD0000081————1
LymphomaD008223C85.91————1
Transitional cell carcinomaD0022951————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameERIBULIN
INNeribulin
Description
Eribulin is a fully synthetic macrocyclic ketone analogue of marine sponge natural products. Inhibits growth phase of microtubules via tubulin-based antimitotic mechanism, which leads to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage It has a role as an antineoplastic agent and a microtubule-destabilising agent. It is a macrocycle, a polyether, a polycyclic ether, a cyclic ketone, a primary amino compound and a cyclic ketal. It is a conjugate base of an eribulin(1+).
Classification
Small molecule
Drug classantineoplastics (mitotic inhibitors; tubulin binders)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=C1C[C@@H]2CC[C@@]34C[C@H]5O[C@H]6[C@@H](O3)[C@H]3O[C@H](CC[C@@H]3O[C@H]6[C@H]5O4)CC(=O)C[C@H]3[C@H](C[C@H]4O[C@@H](CC[C@@H]1O2)C[C@@H](C)C4=C)O[C@H](C[C@H](O)CN)[C@@H]3OC
Identifiers
PDB7DP8
CAS-ID253128-41-5
RxCUI1045453
ChEMBL IDCHEMBL1683590
ChEBI ID63587
PubChem CID11354606
DrugBankDB08871
UNII IDLR24G6354G (ChemIDplus, GSRS)
Target
Agency Approved
TUBB
TUBB
Organism
Homo sapiens
Gene name
TUBB
Gene synonyms
TUBB5
NCBI Gene ID
203068
Protein name
tubulin beta chain
Protein synonyms
beta Ib tubulin, epididymis secretory sperm binding protein, tubulin beta-1 chain, Tubulin beta-5 chain, tubulin, beta polypeptide
Uniprot ID
P07437
Mouse ortholog
Tubb5 (22154)
tubulin beta-5 chain (Q3UF52)
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 3,714 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,946 adverse events reported
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