Halaven

(Eribulin)

ApprovedSmall molecule

Eribulin is used to treat certain types of cancer, including breast cancer and a rare cancer of the blood vessels called liposarcoma. It works by stopping cancer cells from dividing and growing.[2] Halaven is currently approved and in use across 15 indications[4].[1]

Halaven is one of 299 small molecule programs targeting Leiomyosarcoma. It is currently in Approved.

Indications

Total Trials

Active Trials

298

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

LeiomyosarcomaRecruiting

Peripheral NeuropathyActive, not recruiting

AngiosarcomaCompleted

Triple-Negative Breast CancerActive, not recruiting

Breast NeoplasmActive, not recruiting

LiposarcomaActive, not recruiting

Breast CancerTerminated

ImmunotherapyNot yet recruiting

Metastatic Breast CancerActive, not recruiting

HR+/HER2- Breast CancerActive, not recruiting

LeiomyosarcomaPhase 1

Recruiting

Peripheral NeuropathyPreclinical

Active, not recruiting

AngiosarcomaApproved

Completed

Triple-Negative Breast CancerPhase 3

Active, not recruiting

Breast NeoplasmApproved

Active, not recruiting

LiposarcomaApproved

Active, not recruiting

Breast CancerApproved

Terminated

ImmunotherapyPhase 2

Not yet recruiting

Metastatic Breast CancerPhase 3

Active, not recruiting

HR+/HER2- Breast CancerPhase 3

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Halaven

Eisai

Approved

45 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Lexiscan

Astellas

Preclinical

1 5

Voltaren

Novartis

Preclinical

1 6

Zolymbus

AbbVie

Preclinical

1 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 9

Spravato

WWim Janssens

Preclinical

2 10

Duragesic-100

CCephalon

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Triple-Negative Breast Cancer

NCT07255612

Phase 2Active, not recruiting

Inflammatory Breast Cancer

NCT02623972

Phase 3Active, not recruiting

Breast Cancer

NCT05104866

Q2 2027

Phase 2Recruiting

Breast Cancer

NCT06387628

Phase 1/2Recruiting

Patients With Advanced Solid Tumors

NCT05824975

Phase 3Active, not recruiting

Triple-Negative Breast Cancer

NCT06519370

Clinical

Trials by Indication[1]

Breast Cancer45 trials

Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer

Completed·—·Phase 2·NCT02263495·118 enrolled

Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

Terminated·EEmory University·Phase 2·NCT01498588·7 enrolled

Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer

Terminated·—·Phase 2·NCT01912963·32 enrolled

Show 42 more trials

Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment

Completed·MMedSIR·Phase 2·NCT02061085·53 enrolled

Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

Terminated·SSpexis AG·Phase 3·NCT03786094·432 enrolled

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

Active, not recruiting·EEnliven Therapeutics·Phase 1·NCT06328738·275 enrolled

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Active, not recruiting·UUNICANCER·Phase 2·NCT02299999·1,460 enrolled

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

Recruiting·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 1/2·NCT06942234·180 enrolled

Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer

Unknown status·FFudan University·Phase 2·NCT04745975·100 enrolled

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

Completed· Gilead logo

Gilead·Phase 3·NCT03901339·543 enrolled

A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Completed·NNektar Therapeutics·Phase 3·NCT02915744·178 enrolled

POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

Withdrawn·MMedSIR·Phase 1/2·NCT04826016

Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01527487·76 enrolled

Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

Completed·NNSABP Foundation Inc·Phase 2·NCT01705691·50 enrolled

Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer

Not yet recruiting·WWang Jiayu·Phase 2·NCT06539559·60 enrolled

Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT06102824·252 enrolled

First Line Metastatic Breast Cancer Treatment (ESMERALDA)

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT01941407·61 enrolled

Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients

Terminated·MMedSIR·Phase 2·NCT03795012·22 enrolled

PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin

Active, not recruiting·MMedSIR·Phase 2·NCT05810870·14 enrolled

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06081959·376 enrolled

Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer

Terminated·VVector Oncology·Phase 1/2·NCT01388647·12 enrolled

ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer.

Terminated·IImperial College London·Phase 2·NCT02681523·8 enrolled

Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

Completed·—·Phase 1/2·NCT01596751·67 enrolled

Eribulin in Brain Metastases From HER2-negative Breast Cancer

Withdrawn·IInstitut Paoli-Calmettes·Phase 2·NCT03637868

DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

Completed·PProf. Wolfgang Janni·Phase 2·NCT02035813·116 enrolled

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

Recruiting·SSun Yat-sen University·Phase 3·NCT06268652·302 enrolled

A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01427933·141 enrolled

Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT04681911·71 enrolled

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02555657·622 enrolled

Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial

Not yet recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT06308939·81 enrolled

Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT04683445·80 enrolled

Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01593020·54 enrolled

YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer

Not yet recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07461454·376 enrolled

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

Recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT06435429·550 enrolled

Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan··NCT02551263·201 enrolled

Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer

Unknown status·IInstitut fuer Frauengesundheit·Phase 4·NCT05033769·82 enrolled

Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02215876

A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

Completed·JJapan Breast Cancer Research Group·Phase 3·NCT02514681·226 enrolled

Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT01669252·163 enrolled

Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03202316·37 enrolled

LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer

Recruiting·FFudan University·Phase 2·NCT06387628·74 enrolled

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT03734029·557 enrolled

"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05570253·55 enrolled

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05104866·732 enrolled

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

Active, not recruiting·CCriterium, Inc.·Phase 2·NCT05458674·17 enrolled

Triple-Negative Breast Cancer11 trials

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

Completed· Gilead logo

Gilead·Phase 3·NCT02574455·529 enrolled

Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer

Completed·MMedSIR·Phase 2·NCT04464174·54 enrolled

FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Active, not recruiting·SShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.·Phase 3·NCT06519370·350 enrolled

Show 8 more trials

Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer)

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07255612·29 enrolled

PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)

Completed·PPIQUR Therapeutics AG·Phase 1/2·NCT02723877·41 enrolled

Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

Not yet recruiting·SShengjing Hospital·Phase 2·NCT06202313·128 enrolled

Tislelizumab in Combination With Eribulin for Patients With Metastatic Previously heaviLy-treAted TriplE-negative Breast Cancer：A Prospective Multiple-center Phase II Study

Unknown status·FFudan University·Phase 2·NCT04913571·265 enrolled

Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer

Unknown status·—·Phase 2·NCT05402722·30 enrolled

Safety and Tolerability of Everolimus in Combination With Eribulin in Triple-negative Breast Cancers

Unknown status·IIstituti Ospitalieri di Cremona·Phase 1·NCT02616848·1 enrolled

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

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06279364·537 enrolled

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer After Taxane Failure

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06382142·418 enrolled

Carboplatin3 trials

Combination of Carboplatin, Eribulin Mesylate, and E7449 in BRCA-Related Cancers

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 1/2·NCT02396433

A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT01795586·19 enrolled

Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT03032614

Patients With Advanced Solid Tumors2 trials

A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors

Completed· Eisai logo

Eisai·Phase 1·NCT00908908·6 enrolled

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

Recruiting·GGI Innovation, Inc.·Phase 1/2·NCT05824975·358 enrolled

Soft Tissue Sarcoma2 trials

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

Completed·—·Phase 2·NCT03899805·57 enrolled

Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma

Completed·NNational Taiwan University Hospital·Phase 1/2·NCT03526679·30 enrolled

30 more indications

Refractory Solid Tumors2 trials

A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06006273·48 enrolled

A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

Completed·UUniversity of Colorado, Denver·Phase 1·NCT02596503·2 enrolled

Immunotherapy1 trial

JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC

Not yet recruiting·FFudan University·Phase 2·NCT06731153·40 enrolled

Camrelizumab1 trial

A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT04303741·46 enrolled

Paclitaxel1 trial

A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab

Completed·JJapan Breast Cancer Research Group·Phase 3·NCT03264547·446 enrolled

Treatment1 trial

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Metastatic1 trial

Eribulin in HER2 Negative Metastatic BrCa

Completed·—·Phase 2·NCT01827787·83 enrolled

Ovarian Cancer1 trial

Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer

Completed·AAmy Tiersten·Phase 1·NCT03430518·9 enrolled

Biomarkers1 trial

Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy

Terminated·UUniversity of Wisconsin, Madison··NCT03393741·5 enrolled

Peripheral Neuropathy1 trial

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

Completed· Eisai logo

Eisai··NCT03027245·353 enrolled

Leiomyosarcoma1 trial

Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma

Recruiting·WWashington University School of Medicine·Phase 1·NCT06957431·18 enrolled

Advanced Solid Tumors1 trial

Eribulin and Lenvatinib in Advanced Solid Tumors

Completed·—·Phase 2·NCT02640508·29 enrolled

Pembrolizumab1 trial

Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes

Completed·MMedSIR·Phase 2·NCT03222856·44 enrolled

Advanced Malignancies1 trial

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02419495·221 enrolled

Sorafenib1 trial

Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination

Completed· Bayer logo

Bayer·Phase 1·NCT01585870·40 enrolled

Neoadjuvant Chemotherapy1 trial

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01401959·127 enrolled

Solitary Fibrous Tumor1 trial

Eribulin in Advanced Solitary Fibrous Tumor

Completed·IItalian Sarcoma Group·Phase 2·NCT03840772·16 enrolled

Non-Small Cell Lung Cancer1 trial

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

Completed· Eisai logo

Eisai·Phase 3·NCT01454934·540 enrolled

Solid Tumor Malignancies1 trial

Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

Completed·UUniversity of California, San Francisco·Phase 1/2·NCT01554371·44 enrolled

Breast Neoplasms1 trial

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

Recruiting· BioNTech logo

BioNTech·Phase 3·NCT07173751·558 enrolled

Advanced Breast Cancer1 trial

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".

Terminated·SSpanish Breast Cancer Research Group·Phase 3·NCT05063786·27 enrolled

Breast Cancer Metastatic1 trial

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

Recruiting·AALX Oncology Inc.·Phase 2·NCT07007559·120 enrolled

HER2 + Breast Cancer1 trial

A Multicenter, Randomized, Double-Blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07824869·90 enrolled

Endometrial Neoplasms1 trial

Phase 1b/2a Clinical Study of AL58805 Combining With Other Anti-tumor Agents in Advanced, Metastatic GYN, STS or Breast Cancers

Not yet recruiting·AAdvenchen Pharmaceuticals, LLC.·Preclinical·NCT07811232·138 enrolled

Angiosarcoma1 trial

A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

Completed·MMassachusetts General Hospital·Phase 2·NCT03331250·13 enrolled

Sarcoma,Soft Tissue1 trial

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)

Recruiting·IIntensity Therapeutics, Inc.·Phase 3·NCT06263231·333 enrolled

Anatomic Stage IV Breast Cancer AJCC v81 trial

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

Recruiting·UUniversity of Washington·Phase 2·NCT07078604·20 enrolled

HR+/HER2- Breast Cancer1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06343948·383 enrolled

Inflammatory Breast Cancer1 trial

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

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02623972·22 enrolled

Locally Advanced Breast Cancer1 trial

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

Active, not recruiting· BioNTech logo

BioNTech·Phase 2·NCT06449222·83 enrolled

Unspecified2 trials

Scalp Cooling in MBC

Recruiting·—·Phase 2·NCT04986579·120 enrolled

Detect V / CHEVENDO (Chemo vs. Endo)

Active, not recruiting·PProf. Wolfgang Janni·Phase 3·NCT02344472·271 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 15, 2010

HALAVEN

NDA NDA201532

Nov 15, 2010

HALAVEN

NDA NDA201532

Feb 17, 2012

HALAVEN

NDA NDA201532

Nov 7, 2012

HALAVEN

NDA NDA201532

Aug 22, 2013

HALAVEN

NDA NDA201532

Sep 27, 2013

HALAVEN

NDA NDA201532

Oct 24, 2013

HALAVEN

NDA NDA201532

Aug 1, 2014

HALAVEN

NDA NDA201532

Dec 19, 2014

HALAVEN

NDA NDA201532

Apr 10, 2015

HALAVEN

NDA NDA201532

Oct 27, 2015

HALAVEN

NDA NDA201532

Nov 18, 2015

HALAVEN

NDA NDA201532

Jan 28, 2016

HALAVEN

NDA NDA201532

Jul 21, 2016

HALAVEN

NDA NDA201532

Oct 19, 2016

HALAVEN

NDA NDA201532

Feb 19, 2021

HALAVEN

NDA NDA201532

Sep 30, 2021

HALAVEN

NDA NDA201532

Sep 13, 2022

HALAVEN

NDA NDA201532

Sources

References

[1]
ClinicalTrials.gov — 95 trial records for Eribulin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Halaven drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Eribulin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Eribulin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA201532). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Halaven. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tubulin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eisai

Patent Landscape[6]

Patent Cliff

Jan 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE46965Jan 8, 2027

RE46965*PEDJul 8, 2027

Halaven

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Breast Cancer45 trials

Triple-Negative Breast Cancer11 trials

Carboplatin3 trials

Patients With Advanced Solid Tumors2 trials

Soft Tissue Sarcoma2 trials

Refractory Solid Tumors2 trials

Immunotherapy1 trial

Camrelizumab1 trial

Paclitaxel1 trial

Treatment1 trial

Metastatic1 trial

Ovarian Cancer1 trial

Biomarkers1 trial

Peripheral Neuropathy1 trial

Leiomyosarcoma1 trial

Advanced Solid Tumors1 trial

Pembrolizumab1 trial

Advanced Malignancies1 trial

Sorafenib1 trial

Neoadjuvant Chemotherapy1 trial

Solitary Fibrous Tumor1 trial

Non-Small Cell Lung Cancer1 trial

Solid Tumor Malignancies1 trial

Breast Neoplasms1 trial

Advanced Breast Cancer1 trial

Breast Cancer Metastatic1 trial

HER2 + Breast Cancer1 trial

Endometrial Neoplasms1 trial

Angiosarcoma1 trial

Sarcoma,Soft Tissue1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

HR+/HER2- Breast Cancer1 trial

Inflammatory Breast Cancer1 trial

Locally Advanced Breast Cancer1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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