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Drug

Carmustine

Approved · EMA
Late-stage development
Also known as BCNU, BiCNU, Bis(chloroethyl) nitrosourea, Bischloroethyl nitrosourea+5 more

BCNU, BiCNU, Bis(chloroethyl) nitrosourea, Bischloroethyl nitrosourea, CAMUSTINE, Gliadel, N,N'-Bis(2-chloroethyl)-N-nitrosourea, bis-chloroethylnitrosourea, Carmustina.

RxNorm2105ChEMBLCHEMBL513UNIIU68WG3173Y
15
Active clinical trials
1
Regulatory events
Latest activity
beta

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

MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma

Clinical trial2026-07-06Results expected Q3 2026 · ClinicalTrials.gov

A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype

Clinical trial2026-06-30Results posted · ClinicalTrials.gov

A Phase I/II Study of Tebentafusp-tebn in Combination With Liver-Directed Therapies for the Treatment of Metastatic Uveal Melanoma

Clinical trial2026-06-16Results expected Q4 2030 · ClinicalTrials.gov

Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)

Clinical trial2026-06-10Results expected Q1 2031 · ClinicalTrials.gov

Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis

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

A Phase I Trial of High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma

Clinical trial2026-05-28Results expected Q2 2027 · ClinicalTrials.gov

A Phase I Study of Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-Selected CD34+ Cells

Clinical trial2026-05-18Results posted · ClinicalTrials.gov

Chemoembolization of Uveal Melanoma Hepatic Metastases Using 300mg of BCNU Dissolved in Lipiodol® Followed by Gelfoam® Embolization

Clinical trial2026-05-06Results expected Q1 2027 · ClinicalTrials.gov

Safety and Feasibility Study for CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant (CNS-PHLAT)

Clinical trial2026-03-31Results expected Q3 2027 · ClinicalTrials.gov

A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)

Clinical trial2026-03-27Results expected Q1 2027 · ClinicalTrials.gov

Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma

Clinical trial2026-03-19Results posted · ClinicalTrials.gov

Approval: Carmustine medac (previously Carmustine Obvius) (EMA)

Regulatory2018-07-18EMA

Profile

Identifiers & mechanism

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

Canonical name
Carmustine
Aliases & brands
BCNUBiCNUBis(chloroethyl) nitrosoureaBischloroethyl nitrosoureaCAMUSTINEGliadelN,N'-Bis(2-chloroethyl)-N-nitrosoureabis-chloroethylnitrosoureaCarmustina
RxNorm CUI
2105
ChEMBL ID
CHEMBL513
UNII
U68WG3173Y
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
2018-07-18
Latest approval
2018-07-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-07-18Approval
Approval: Carmustine medac (previously Carmustine Obvius) (EMA)
Indication: Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures… Show full indication

Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).

Evidence ↗

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

Clinical trials

185 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
185
registered trials across all phases
LATEST COMPLETION 2026
15
Active studies
9
Recruiting
43
Late-stage (III+)
117
Completed
53
Discontinued
PHASE DISTRIBUTIONn = 185
Phase 128Phase 1 / 218Phase 296Phase 2 / 31Phase 334Phase N / A8

Late-stage studies

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

A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype

Active, not recruitingPH IIINational Cancer Institute (NCI)n=942026

ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial

Unknown statusPH IIISichuan Universityn=3062025

SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring ASCT for Relapsed DLBCL

TerminatedPH IIICity of Hope Medical Centern=32016

Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma

TerminatedPH IIIFrench Innovative Leukemia Organisationn=4422016

Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation

Unknown statusPH IIIEuropean Mantle Cell Lymphoma Networkn=3602014

Recent completions

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

High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma

CompletedPH ICity of Hope Medical Centern=252026

Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma

CompletedPH IIInternational Extranodal Lymphoma Study Group (IELSG)n=2272024

Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance

CompletedPH IIThe Lymphoma Academic Research Organisationn=862024

Phase I Study of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Plus Standard BEAM Conditioning for Autologous Hematopoietic Cell Transplantation in Patients With Mature T-Cell Non-Hodgkin Lymphoma: the aTAC BEAM Regimen

CompletedPH ICity of Hope Medical Centern=202024

Phase I Study of Yttrium-90 Labeled Anti-CD25 (a-Tac) Monoclonal Antibody Plus BEAM for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma, the "a-Tac BEAM Regimen"

CompletedPH ICity of Hope Medical Centern=252024

An International Phase II Trial Assessing Tolerability and Efficacy of Sequential Methotrexate-Aracytin-based Combination and R-ICE Combination, Followed by HD Chemotherapy Supported by ASCT, in Patients With Systemic B-cell Lymphoma With CNS Involvement at Diagnosis or Relapse (MARIETTA Regimen)

CompletedPH IIInternational Extranodal Lymphoma Study Group (IELSG)n=792024
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.