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AboutPricing
Drug ReportsEribulin
Halaven(eribulin)
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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YTD
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Eribulin, 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
eribulin mesylateANDA2025-10-03
halavenNew Drug Application2025-11-07
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
261 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_0003869C50329438425175
Male breast neoplasmsD018567———1—1—2
Drug-related side effects and adverse reactionsD064420—T88.7———1—1
Neurotoxicity syndromesD020258—G92———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD064726——122913—353
NeoplasmsD009369—C803082——34
SarcomaD012509——792—116
Neoplasm metastasisD009362EFO_0009708—376——15
CarcinomaD002277—C80.0651——9
RecurrenceD012008——251—18
Non-small-cell lung carcinomaD002289——341——7
Brain neoplasmsD001932EFO_0003833C71241——6
Transitional cell carcinomaD002295——231——5
Urinary bladder neoplasmsD001749—C67131——4
Show 8 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C5641———5
Ovarian epithelial carcinomaD000077216——31———4
Lung neoplasmsD008175—C34.9023———4
Prostatic neoplasmsD011471—C6122———4
LiposarcomaD008080——32———4
Inflammatory breast neoplasmsD058922——13———3
MelanomaD008545——22———3
LeiomyosarcomaD007890——22———3
Colorectal neoplasmsD015179——22———3
Urethral neoplasmsD014523EFO_0003846——2———2
Show 31 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.92————2
Skin neoplasmsD012878EFO_0004198C441————1
Cutaneous malignant melanomaD000096142——1————1
Abdominal neoplasmsD000008——1————1
Retroperitoneal neoplasmsD012186——1————1
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peripheral nervous system diseasesD010523—G64————22
Alopecia areataD000506EFO_0004192L63————11
AlopeciaD000505—L64————11
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)Loading
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
PDB—
CAS-ID253128-41-5
RxCUI—
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
Q9CY33
Mouse ortholog
Tubb5 (22154)
tubulin beta-5 chain (Q3UF52)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,837 adverse events reported
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