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Drug

Eribulin

Approved · EMA
Late-stage development

Also known as Halaven, Eribulina, Eribulin Mesylate.

RxNorm1045453ChEMBLCHEMBL1683590UNIILR24G6354G
35
Active clinical trials
1
Regulatory events
Latest activity
beta

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

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

Clinical trial2026-07-17Results expected Q4 2029 · ClinicalTrials.gov

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Clinical trial2026-07-10Results expected Q2 2027 · ClinicalTrials.gov

A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

Clinical trial2026-06-30Results expected Q3 2028 · ClinicalTrials.gov

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Clinical trial2026-06-18Results expected Q2 2028 · ClinicalTrials.gov

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) or Atezolizumab + Eribulin (AE) in Patients With Recurrent/Metastatic Inflammatory Breast Cancer

Clinical trial2026-06-10Results expected Q4 2027 · ClinicalTrials.gov

Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Clinical trial2026-06-05Results expected Q4 2027 · ClinicalTrials.gov

A Phase I Trial of Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma

Clinical trial2026-06-03Results expected Q2 2031 · ClinicalTrials.gov

A Randomized Phase III Trial of Trastuzumab + ALpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer. "ALPHABET Study".

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)

Clinical trial2026-05-31Withdrawn · ClinicalTrials.gov

Approval: Halaven (EMA)

Regulatory2011-03-17EMA

Profile

Identifiers & mechanism

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

Canonical name
Eribulin
Aliases & brands
HalavenEribulinaEribulin Mesylate
RxNorm CUI
1045453
ChEMBL ID
CHEMBL1683590
UNII
LR24G6354G
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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
2011-03-17
Latest approval
2011-03-17
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2011-03-17Approval
Approval: Halaven (EMA)
Indication: Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens… Show full indication

Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. Halaven 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 (see section 5.1).

Evidence ↗

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

Clinical trials

89 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
89
registered trials across all phases
LATEST COMPLETION 2025
35
Active studies
20
Recruiting
23
Late-stage (III+)
33
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 89
Early Phase 11Phase 111Phase 1 / 29Phase 245Phase 322Phase 41

Late-stage studies

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

AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study

Unknown statusPH IVInstitut fuer Frauengesundheitn=822023

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

RecruitingPH IIIJazz Pharmaceuticalsn=5502030

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

RecruitingPH IIIBioNTech SEn=5582030

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

Active, not recruitingPH IIIIntensity Therapeutics, Inc.n=3332028

A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

RecruitingPH IIIMediLink Therapeutics (Suzhou) Co., Ltd.n=3762028

Recent completions

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

A Single-arm Phase Ib/II Study of the Combination of Lenvatinib and Eribulin in Advanced Adipocytic Sarcoma and Leiomyosarcoma (LEADER Study)

CompletedPH I/IINational Taiwan University Hospitaln=302025

A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)

CompletedPH IIIJapan Breast Cancer Research Groupn=4462024

ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)

CompletedPH IIItalian Sarcoma Groupn=162024

A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas

CompletedPH IIDana-Farber Cancer Instituten=572024

DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

CompletedPH IIProf. Wolfgang Jannin=1162024

A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic TNBC Patients

CompletedPH IIMedSIRn=542023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.