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Drug

Eribulin mesylate

Approved · EMA
Late-stage development

Also known as Halaven, Eribulin mesilate.

14
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer

Clinical trial2025-11-06Results posted · ClinicalTrials.gov

Approval: Eribulin Baxter (EMA)

Regulatory2024-06-27EMA

Approval: Mevlyq (EMA)

Regulatory2024-02-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Eribulin mesylate
Aliases & brands
HalavenEribulin mesilate
RxNorm CUI
1045452
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-02-09
Latest approval
2024-06-27
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2024-06-27Approval
Approval: Eribulin Baxter (EMA)
Indication: Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimenShow full indication

Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease

Evidence ↗
2024-02-09Approval
Approval: Mevlyq (EMA)
Indication: Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen forShow full indication

Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Mevlyq is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

68 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
68
registered trials across all phases
LATEST COMPLETION 2024
14
Active studies
7
Recruiting
12
Late-stage (III+)
39
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 68
Early Phase 11Phase 113Phase 1 / 210Phase 232Phase 38Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.