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Eribulin mesylate injection
Eribulin mesylate injection is a Microtubule inhibitor Small molecule drug developed by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. It is currently in Phase 3 development for Metastatic breast cancer, Liposarcoma, Other solid tumors (in clinical development). Also known as: Halaven.
Eribulin mesylate is a microtubule dynamics inhibitor that binds to tubulin and suppresses microtubule growth, leading to cell cycle arrest and apoptosis in cancer cells.
Eribulin mesylate is a microtubule dynamics inhibitor that binds to tubulin and suppresses microtubule growth, leading to cell cycle arrest and apoptosis in cancer cells. Used for Metastatic breast cancer, Liposarcoma, Other solid tumors (in clinical development).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Eribulin mesylate injection |
|---|---|
| Also known as | Halaven |
| Sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
| Drug class | Microtubule inhibitor |
| Target | Tubulin (microtubule dynamics) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Eribulin mesylate is a non-taxane microtubule inhibitor that works by binding to the plus end of microtubules and inhibiting their growth phase while allowing shortening to continue, resulting in net loss of microtubule mass. This disruption of microtubule dynamics leads to G2/M cell cycle arrest and triggers apoptosis in rapidly dividing cancer cells. Unlike taxanes, eribulin does not stabilize microtubules but rather destabilizes them through a unique mechanism of action.
Approved indications
- Metastatic breast cancer
- Liposarcoma
- Other solid tumors (in clinical development)
Common side effects
- Neutropenia
- Peripheral neuropathy
- Anemia
- Fatigue
- Nausea
- Alopecia
- Diarrhea
Key clinical trials
- Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer (PHASE3)
- Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer (PHASE1, PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer (PHASE2)
- Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) (PHASE3)
- TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer (PHASE3)
- Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (PHASE3)
- SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Eribulin mesylate injection CI brief — competitive landscape report
- Eribulin mesylate injection updates RSS · CI watch RSS
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd portfolio CI
Frequently asked questions about Eribulin mesylate injection
What is Eribulin mesylate injection?
How does Eribulin mesylate injection work?
What is Eribulin mesylate injection used for?
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Is Eribulin mesylate injection also known as anything else?
What drug class is Eribulin mesylate injection in?
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Related
- Drug class: All Microtubule inhibitor drugs
- Target: All drugs targeting Tubulin (microtubule dynamics)
- Manufacturer: Jiangsu Alphamab Biopharmaceuticals Co., Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic breast cancer
- Indication: Drugs for Liposarcoma
- Indication: Drugs for Other solid tumors (in clinical development)
- Also known as: Halaven
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing