Drug · Small Molecule

Cyclophosphamide

CI-DRUG-00000166Explore in graph →NCIt C405 CHEMBL1200796 CIViC Approved

Regulatory

Approvals (43)

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

openfdaRegulatory12 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Neuroblastoma	neuroblastoma (disseminated disease)	approved	Sep 12, 2023	openfda
US FDA	—	malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s lymphoma, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma • leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) • carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Limitations of Use This cyclophosphamide product is not indicated for use in pediatric patients due to the to the alcohol and propylene glycol content in this product. If treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 ), and Description ( 11 )] . Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult patients with: Malignant Diseases: malignant lymphomas: Hodgkin’s lymphoma, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1 ) Limitations of Use This cyclophosphamide product is not indicated for use in pediatric patients due to the alcohol and propylene glycol content in this product. If treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product. ( 1 )

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 2 days 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 4	702	368	500	2,823	43	CA, US	Nov 16, 1959	1987-08
Non-Hodgkin Lymphoma	Approved	Phase 4	209	102	95	660	2	US	Sep 12, 2023	1988-03
Multiple Myeloma	Approved	Phase 4	46	22	26	223	1	US	Sep 12, 2023	1988-03
Malignant Central Nervous System Neoplasm	Approved	Phase 3	26	17	11	58

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
TOP1 EXPRESSION1
Carboplatin + Cyclophosphamide

Clinical trials

Trials with this intervention (2,848)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 2,751–2,800 of 2,848 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
NCT00844506	p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer(ISA-P53-CTX)	completed	Phase 2	19	University Medical Center GroningenOTHER	1	Feb 25, 2011	clinicaltrials
NCT00028964	Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: DNA inhibitor
UNII: 8N3DW7272P
Aliases: 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin Monohydrate, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide Monohydrate, 2-[bis(b-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane-2-oxide Monohydrate, 2-[di(chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide Monohydrate, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, Monohydrate, Asta B 518, B 518, B-518, B518, Bis(2-chloroethyl)phosphamide Cyclic Propanolamide Ester Monohydrate, Bis(2-chloroethyl)phosphoramide Cyclic Propanolamide Ester Monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP Monohydrate, CTX, Cycloblastin, Cycloblastine, CYCLO-cell, Cyclophospham, (-)-Cyclophosphamide, Cyclophosphamide, Cyclophosphamide hydrate, Cyclophosphamide Monohydrate, Cyclophosphamid Monohydrate, Cyclophosphamidum, Cyclophosphan … (+34)

Data updated 20 hours agoSource updated unknown

Identifiers

Codes (63)

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

System	Code	Label
ATC (WHO)	L01AA01	CYCLOPHOSPHAMIDE