CeeNU

(lomustine)

ApprovedSmall molecule

Lomustine is a chemotherapy drug used to treat certain types of cancer, including brain tumors and lymphoma, by damaging cancer cell DNA to stop them from growing.[2] CeeNU is currently approved and in use across 12 indications[4].[1]

CeeNU is one of 258 small molecule programs targeting Primitive Neuroectodermal Tumor. It is currently in Approved.

Indications

Total Trials

Active Trials

257

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Primitive Neuroectodermal TumorActive, not recruiting

Lung CancerApproved

Anaplastic Large Cell LymphomaActive, not recruiting

Central Nervous System NeoplasmApproved

Hodgkins LymphomaActive, not recruiting

GliosarcomaApproved

Brain NeoplasmActive, not recruiting

Childhood MedulloblastomaRecruiting

GlioblastomaNot yet recruiting

Acute Myeloid LeukemiaApproved

Primitive Neuroectodermal TumorPreclinical

Active, not recruiting

Lung CancerApproved

Approved

Anaplastic Large Cell LymphomaPreclinical

Active, not recruiting

Central Nervous System NeoplasmApproved

Approved

Hodgkins LymphomaApproved

Active, not recruiting

GliosarcomaApproved

Approved

Brain NeoplasmApproved

Active, not recruiting

Childhood MedulloblastomaPhase 3

Recruiting

GlioblastomaPhase 3

Not yet recruiting

Acute Myeloid LeukemiaApproved

Approved

Showing 10 of 12 indications

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

CeeNU

AAzurity Pharmaceuticals

Approved

83 2

Idamycin

Pfizer

Phase 3

60 3

Novantrone

Pfizer

Phase 3

34 4

Xospata

Astellas

Phase 3

24 5

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 6

Vepesid

AAvyxa

Phase 3

52 7

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

42 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

30 9

Nexavar

Cellcept

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

Timeline

Expected Milestones

Q3 2027

Phase 1Recruiting

Glioblastoma

NCT07145112

Q4 2027

Phase 2Active, not recruiting

Glioblastoma

NCT04049669

Q1 2028

Recruiting

Glioblastoma

NCT06283927

Phase 3Recruiting

Glioblastoma

NCT05904119

Phase 2Active, not recruiting

Medulloblastoma

NCT02724579

Q2 2028

Phase 3Recruiting

Glioblastoma

NCT05902169

Clinical

Trials by Indication[1]

Glioblastoma22 trials

A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence

Recruiting·PPhilogen S.p.A.·Phase 2·NCT06336291·90 enrolled

Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma

Withdrawn·—·N/A·NCT05410301

A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma

Completed· Roche logo

Roche·Phase 2·NCT01860638·296 enrolled

Show 19 more trials

Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

Not yet recruiting·VVastra Gotaland Region·Phase 3·NCT06419946·200 enrolled

Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00948389·28 enrolled

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)

Recruiting·JJasper Gerritsen··NCT06283927·464 enrolled

Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression

Withdrawn·PPhilogen S.p.A.·Phase 1·NCT05304663

Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma

Withdrawn·EEmory University·Phase 1·NCT05017610

A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression

Recruiting·PPhilogen S.p.A.·Phase 1/2·NCT04573192·142 enrolled

Regorafenib in Relapsed Glioblastoma

Completed·IIstituto Oncologico Veneto IRCCS·Phase 2·NCT02926222·119 enrolled

A Study in Recurrent Glioblastoma (GB)

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01582269·158 enrolled

Enzastaurin Versus Lomustine in Glioblastoma

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00295815·397 enrolled

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

Completed· AbbVie logo

AbbVie·Phase 2·NCT02343406·266 enrolled

A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

Terminated·KKaryopharm Therapeutics Inc·Phase 1/2·NCT04421378·74 enrolled

Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study

Recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT05904119·411 enrolled

Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

Recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT04863950·25 enrolled

Phase 2 Trial of Indoximod With Chemotherapy and Radiation for Children With Progressive Brain Tumors or Newly Diagnosed DIPG

Active, not recruiting·TTheodore S. Johnson·Phase 2·NCT04049669·130 enrolled

GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Recruiting·GGlobal Coalition for Adaptive Research·Preclinical·NCT03970447·2,250 enrolled

A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.

Recruiting·CCarThera·Phase 3·NCT05902169·560 enrolled

A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults

Recruiting·UUniversity of California, Davis·Phase 1·NCT07145112·25 enrolled

A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma

Active, not recruiting·NNRG Oncology·Phase 3·NCT05095376·265 enrolled

Tofacitinib: Suppressing Tumor Invasion in Recurrent GBM Patients

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT05326464·18 enrolled

Medulloblastoma9 trials

Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02212574·6 enrolled

Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

Unknown status·UUniversity of Leicester·Phase 3·NCT00053872·316 enrolled

Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00002875·421 enrolled

Show 6 more trials

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00085735·549 enrolled

Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00276666·29 enrolled

Low-Dose Radiation and Combination Chemotherapy Following Surgery in Children With Newly Diagnosed Medulloblastoma

Terminated·—·Phase 2·NCT00031590·30 enrolled

Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04402073·20 enrolled

Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma

Completed·MMemorial Sloan Kettering Cancer Center·N/A·NCT00058370·6 enrolled

A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT02724579·45 enrolled

Glioma8 trials

The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma

Terminated·TTocagen Inc.·Phase 2/3·NCT02414165·403 enrolled

Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

Completed·CChildren's Oncology Group·Phase 2·NCT00100802·118 enrolled

Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2/3·NCT00003375·370 enrolled

Show 5 more trials

6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00504660·75 enrolled

Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas

Unknown status·GGerman Society for Pediatric Oncology and Hematology GPOH gGmbH·Phase 3·NCT00278278·150 enrolled

Chemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00002806·43 enrolled

Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma

Terminated·AAnnick Desjardins·Phase 1·NCT01989052·9 enrolled

Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas

Unknown status·CColorado Health Foundation·Phase 3·NCT00003788·270 enrolled

Glioblastoma Multiforme7 trials

A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme

Unknown status·AAmsterdam UMC, location VUmc·Phase 2/3·NCT03025893·100 enrolled

Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

Completed· Novartis logo

Novartis·Phase 1·NCT01934361·35 enrolled

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

Active, not recruiting·CCNS Pharmaceuticals, Inc.·Phase 2·NCT04762069·210 enrolled

Show 4 more trials

Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme

Completed· Pfizer logo

Pfizer·Phase 3·NCT00068952·118 enrolled

Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01067469·83 enrolled

Phase 1/2 Study of USL311 +/- Lomustine in Advanced Solid Tumors or Relapsed/Recurrent Glioblastoma Multiforme (GBM)

Terminated·PProximagen, LLC·Phase 1/2·NCT02765165·26 enrolled

Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma

Suspended·NNational Cancer Institute (NCI)·Phase 2·NCT06325683·184 enrolled

Lymphoma5 trials

Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-Hodgkin Lymphoma

Completed·AAIDS Malignancy Consortium·Phase 2·NCT01775475·7 enrolled

Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma

Unknown status·UUniversity Hospital Freiburg·Phase 2·NCT00989352·56 enrolled

Methotrexate, Procarbazine, Lomustine, Dexamethasone, and Cytarabine in Treating Patients With Primary CNS Lymphoma

Completed·OOHSU Knight Cancer Institute·Phase 2·NCT00074191·1 enrolled

Show 2 more trials

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

Completed·—·Phase 2·NCT00049439·54 enrolled

Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkin's Lymphomas

Terminated·—·Phase 2·NCT00003113·6 enrolled

22 more indications

Malignant Glioma4 trials

A Dose-Escalation Study in Participants With Recurrent Malignant Glioma

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01682187·66 enrolled

Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma

Completed·IInstitute of Cancer Research, United Kingdom·Phase 3·NCT00052455·500 enrolled

Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma

Completed·CChildren's Oncology Group·Phase 1·NCT00006024·32 enrolled

Show 1 more trial

Lerapolturev in Recurrent Malignant Glioma

Completed·IIstari Oncology, Inc.·Phase 2·NCT02986178·121 enrolled

Anaplastic Astrocytoma3 trials

Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03022578·7 enrolled

Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma

Terminated·IIsarna Therapeutics GmbH·Phase 3·NCT00761280·27 enrolled

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Unknown status·OOrbus Therapeutics, Inc.·Phase 3·NCT02796261·343 enrolled

Chemotherapy3 trials

Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00503204·20 enrolled

Combination Chemotherapy Plus Gene Therapy in Treating Patients With CNS Tumors

Completed·IIndiana University·Phase 1·NCT00005796·10 enrolled

Combination Chemotherapy in Treating Children With Progressive Brain Tumors

Completed·CChildren's Oncology Group·Phase 3·NCT00002944·428 enrolled

Primitive Neuroectodermal Tumor2 trials

Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

Completed·UUniversitätsklinikum Hamburg-Eppendorf·N/A·NCT00303810·567 enrolled

Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00274911·30 enrolled

Anaplastic Oligodendroglioma2 trials

Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00002569·299 enrolled

Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002840·350 enrolled

Melanoma2 trials

Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00072345

Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00527657·17 enrolled

Metastasis1 trial

A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain

Terminated·UUniversity Hospital, Bonn·Phase 1·NCT01563614·1 enrolled

Leukemia1 trial

Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

Completed·UUniversity Hospital, Bordeaux·Phase 3·NCT00590837·459 enrolled

Advanced Cancers1 trial

9-ING-41 in Patients with Advanced Cancers

Active, not recruiting·AActuate Therapeutics Inc.·Phase 2·NCT03678883·350 enrolled

Recurrent1 trial

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects

Recruiting·VVBI Vaccines Inc.·Phase 1/2·NCT03382977·98 enrolled

Bevacizumab1 trial

Bevacizumab and Lomustine for Recurrent GBM

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT01290939·592 enrolled

Multiple Myeloma1 trial

Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

Unknown status·RRiverside Haematology Group·Phase 3·NCT00003603·660 enrolled

Anaplastic Large Cell Lymphoma1 trial

Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

Unknown status·EEuropean Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma·N/A·NCT00317408·96 enrolled

Bone Marrow Transplantation1 trial

Combination Chemotherapy and Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Oligodendroglioma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003101·60 enrolled

Central Nervous System Lymphoma1 trial

Chemotherapy, Filgrastim, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Withdrawn·—·Phase 2·NCT00003929

Completed·—·Phase 2·NCT00003114·5 enrolled

Thrombocytopenia1 trial

Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04933942

Brain Cancer1 trial

A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer

Completed·SSaint John's Cancer Institute·Phase 1·NCT03425292·49 enrolled

Recurrent Glioma1 trial

VALIENT: Phase 1 Clinical Trial of VorAsidenib in Combination With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

Not yet recruiting·MMegan Mantica·Phase 1·NCT07629089·36 enrolled

Childhood Medulloblastoma1 trial

A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features

Recruiting·CChildren's Oncology Group·Phase 3·NCT05382338·225 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 19, 2014

GLEOSTINE

NDA NDA017588

Sources

References

[1]
ClinicalTrials.gov — 83 trial records for lomustine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — CeeNU drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — lomustine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for lomustine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017588). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

CeeNU

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Glioblastoma22 trials

Medulloblastoma9 trials

Glioma8 trials

Glioblastoma Multiforme7 trials

Lymphoma5 trials

Malignant Glioma4 trials

Anaplastic Astrocytoma3 trials

Chemotherapy3 trials

Primitive Neuroectodermal Tumor2 trials

Anaplastic Oligodendroglioma2 trials

Melanoma2 trials

Metastasis1 trial

Leukemia1 trial

Advanced Cancers1 trial

Recurrent1 trial

Bevacizumab1 trial

Multiple Myeloma1 trial

Anaplastic Large Cell Lymphoma1 trial

Bone Marrow Transplantation1 trial

Central Nervous System Lymphoma1 trial

Non-Small Cell Lung Cancer1 trial

Safety and Efficacy1 trial

Hodgkin's Disease1 trial

Thrombocytopenia1 trial

Brain Cancer1 trial

Recurrent Glioma1 trial

Childhood Medulloblastoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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