Drug · Small Molecule

Carmustine

CI-DRUG-00000144Explore in graph →NCIt C349 CHEMBL513 CIViC Approved

Regulatory

Approvals (8)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2003-02-25 (see label)	approved	Feb 25, 2003	openfda
US FDA	—	GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )	approved	Sep 23, 1996	openfda
US FDA	—	Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	14	9	36	191	8	CA, EU, US	Dec 31, 1975	1988-04
Non-Hodgkin Lymphoma	Phase3	Phase 3	6	3	8	49	0	—	—	1994-01
Malignant Breast Neoplasm	Phase3	Phase 3	1	1	2	5	0	—	—	1991-12
Malignant Central Nervous System Neoplasm	Phase3	Phase 3	1	1	4	15	0

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
MGMT Promoter Methylation1
Carmustine	Glioblastoma

Clinical trials

Trials with this intervention (191)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–191 of 191 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00002988	Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma	completed	Phase 1	36	Duke UniversityOTHER	1	Jun 20, 2013	clinicaltrials
NCT00003467	Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma	completed	Phase 2	68

Molecule

Record

Kind: Small Molecule
Mechanism: Glutathione reductase inhibitor; DNA inhibitor; RNA inhibitor
Targets: 1 gene
UNII: U68WG3173Y
Aliases: 1,3-Bis(2-chloroethyl)-1-nitrosourea, 1,3-Bis(beta-chloroethyl)-1-nitrosourea, BCNU, Becenum, Becenun, Bicnu, BiCNU, Bischloroethyl nitrosourea, Bis(chloroethyl) Nitrosourea, Bis-Chloronitrosourea, Camustine, Carmubris, Carmustin, Carmustina, Carmustine, Carmustine medac, Carmustine medac (previously carmustine obvius), Carmustine obvius, Carmustinum, DTI-015, FDA 0345, FDA-0345, GLIADEL, GLIADEL WAFER, Nitrourean, Nitrumon, N,N'-Bis(2-chloroethyl)-N-nitrosourea, NSC 409962, NSC-409962, NSC409962 … (+6)

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (10)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01AD01	CARMUSTINE
DIN (Health Canada)	00297763