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Blenoxane

(bleomycin sulfate)

Phase 3Biologic

Bristol-Myers Squibb

Bleomycin sulfate is a chemotherapy drug used to treat various cancers, including testicular cancer, lymphomas, and certain types of head and neck cancers. It works by damaging cancer cell DNA to stop them from growing and dividing.[1] Blenoxane is currently being investigated across 5 indications[3], with its most advanced program in Phase 3.[1]

Blenoxane is one of 127 biologic programs targeting Squamous Cell Carcinoma. It is currently in Phase 3.

5

Indications

69

Total Trials

6

Active Trials

126

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Squamous Cell CarcinomaUnknown

Pleural EffusionUnknown

Hodgkins LymphomaUnknown

Diffuse Large B-Cell LymphomaActive, not recruiting

Germ Cell TumorCompleted

Squamous Cell CarcinomaPreclinical

Unknown

Pleural EffusionPreclinical

Unknown

Hodgkins LymphomaPreclinical

Unknown

Diffuse Large B-Cell LymphomaPreclinical

Active, not recruiting

Germ Cell TumorPhase 3

Completed

Competition

Competitive Landscape

109 competitors in Diffuse Large B-Cell Lymphoma

#DrugCompanyPhaseTrials

Adriamycin

Rituxan

Oncovin

Polivy

Gemzar

Johnson & Johnson

Adriamycin

Gazyva

Oncovin

Cytoxan

BBaxter Healthcare Corporation

Rayos

RRoxane Laboratories

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Ann Arbor Stage IIB Hodgkin Lymphoma

NCT02166463

Q2 2027

Phase 3Recruiting

Germ Cell Tumor

NCT03067181

Q2 2031

Phase 3Recruiting

Hodgkin Lymphoma

NCT05675410

Clinical

Trials by Indication[1]

Lymphoma25 trials

Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT01132807·164 enrolled

Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

Completed·LLymphoma Trials Office·Phase 3·NCT00005867·310 enrolled

Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkin's Lymphoma

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00025064·260 enrolled

Show 22 more trials

Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma

Completed·UUniversity College, London·Phase 3·NCT00678327·1,202 enrolled

Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Unknown status·LLymphoma Trials Office·Phase 1·NCT00031902

Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00379041·1,158 enrolled

Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

Unknown status·MMount Vernon Cancer Centre at Mount Vernon Hospital·Phase 3·NCT00041210·850 enrolled

Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma

Completed·—·Phase 2·NCT00003110·5 enrolled

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

Completed·SStanford University·Phase 2·NCT00002715·50 enrolled

A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

Completed·NNewcastle-upon-Tyne Hospitals NHS Trust·Phase 2·NCT00079105·175 enrolled

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

Completed·SSWOG Cancer Research Network·Phase 2·NCT00822120·371 enrolled

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000658·250 enrolled

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00005584·1,649 enrolled

Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Unknown status·LLymphoma Trials Office·Phase 1/2·NCT00032149·30 enrolled

Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000703·45 enrolled

Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000689·18 enrolled

Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

Completed·CChildren's Oncology Group·Phase 3·NCT01026220·166 enrolled

Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma

Terminated·FFrench Innovative Leukemia Organisation·Phase 3·NCT00920153·442 enrolled

Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002565·61 enrolled

Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma

Unknown status·CChildren's Cancer and Leukaemia Group·N/A·NCT00416377·353 enrolled

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00049595·552 enrolled

Combination Chemotherapy in Treating Patients With Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002835·116 enrolled

Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell Lymphoma

Withdrawn·OOhio State University Comprehensive Cancer Center·Phase 2·NCT00983944

Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002524·46 enrolled

SWOG-9320 Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

Completed·SSWOG Cancer Research Network·Phase 2·NCT00002571·52 enrolled

Germ Cell Tumor10 trials

Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00002596·270 enrolled

Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors

Unknown status·CChildren's Cancer and Leukaemia Group·N/A·NCT00276718·100 enrolled

Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

Completed·CChildren's Oncology Group·Phase 2·NCT00003811·27 enrolled

Show 7 more trials

Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

Completed·MMedical Research Council·Phase 2·NCT00301782·88 enrolled

Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

Completed·CChildren's Oncology Group·Phase 3·NCT00053352·302 enrolled

Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

Completed·—·Phase 2·NCT00453232·20 enrolled

Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 3·NCT00274950·105 enrolled

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

Completed·UUNICANCER·Phase 3·NCT00104676·263 enrolled

Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

Completed·CChildren's Oncology Group·N/A·NCT00066482·19 enrolled

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

Recruiting·CChildren's Oncology Group·Phase 3·NCT03067181·1,780 enrolled

Hodgkin's Disease10 trials

Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease

Unknown status·MMedical Research Council·Phase 3·NCT00002987·400 enrolled

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease

Completed·MMedical Research Council·Phase 3·NCT00003421·800 enrolled

Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000626·27 enrolled

Show 7 more trials

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

Completed·CChildren's Oncology Group·Phase 3·NCT00025259·1,734 enrolled

Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease

Completed·CChildren's Oncology Group·Phase 3·NCT00002827·294 enrolled

Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease

Completed·CChildren's Oncology Group·Phase 3·NCT00005578·219 enrolled

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease

Completed·SStanford University·Phase 2·NCT00002714

Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease

Completed·CChildren's Oncology Group·Phase 2·NCT00004010·99 enrolled

Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00002561·405 enrolled

RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002462·615 enrolled

Kaposi's sarcoma5 trials

A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000681·24 enrolled

A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000954·72 enrolled

A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

Completed·NNexstar Pharmaceuticals·Phase 3·NCT00002093

Show 2 more trials

A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

Unknown status·SSequus Pharmaceuticals·Phase 3·NCT00002318·225 enrolled

A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000987·36 enrolled

Liposomal Doxorubicin2 trials

Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma

Completed·SSequus Pharmaceuticals·Phase 3·NCT00002105·220 enrolled

Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001059·120 enrolled

17 more indications

Immunosuppression1 trial

SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant

Completed·SSWOG Cancer Research Network·Phase 2·NCT00002657·20 enrolled

Chemotherapy1 trial

Combination Chemotherapy in Treating Men With Germ Cell Cancer

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2/3·NCT00003643·498 enrolled

Stem Cell Transplant1 trial

Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003941·222 enrolled

Pleural effusion1 trial

Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00002872·480 enrolled

Metastatic1 trial

Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles

Completed·QQueen Mary University of London·Phase 3·NCT00324298·210 enrolled

Cervical Cancer1 trial

Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003209·700 enrolled

Bone Marrow Transplantation1 trial

Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

Unknown status·SScotland and Newcastle Lymphoma Group·Phase 3·NCT00003815

Quality of Life1 trial

Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine

Completed·AAIDS Malignancy Consortium··NCT03596918·10 enrolled

Advanced Head and Neck Cancer1 trial

Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

Completed·CCancer Research UK·Phase 3·NCT00002476

Carboplatin1 trial

Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

Unknown status·GGOG Foundation·Phase 2·NCT01042522·63 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma

Unknown status·UUniversity Hospital Southampton NHS Foundation Trust·N/A·NCT00689845·120 enrolled

Stem Cell Transplantation1 trial

S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease

Terminated·SSWOG Cancer Research Network·Phase 3·NCT00005090·11 enrolled

HIV infection1 trial

Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection

Unknown status·CCentro di Riferimento Oncologico - Aviano·Phase 2·NCT00003262·30 enrolled

Melanoma1 trial

Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma

Unknown status·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT00006035

Pancreatic Cancer1 trial

Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer

Withdrawn·IIchor Medical Systems Incorporated·Phase 1·NCT00027521

Hodgkin Lymphoma1 trial

A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT05675410·1,875 enrolled

Ann Arbor Stage IIB Hodgkin Lymphoma1 trial

A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02166463·600 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

BLENOXANE

NDA NDA050443

Sources

References

[1]
ClinicalTrials.gov — 69 trial records for bleomycin sulfate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — bleomycin sulfate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for bleomycin sulfate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050443). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

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