Cyclophosphamide - PharmaKB

Cyclophosphamide

Cytoxan (cyclophosphamide) is a small molecule pharmaceutical. Cyclophosphamide was first approved as Cytoxan on 1982-01-01. It is used to treat b-cell chronic lymphocytic leukemia, BCR-ABL positive chronic myelogenous leukemia, breast neoplasms, burkitt lymphoma, and endometrial neoplasms amongst others in the USA.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Completion date

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
neoplasms	D009369
musculoskeletal diseases	D009140
respiratory tract diseases	D012140
nervous system diseases	D009422
eye diseases	D005128
urogenital diseases	D000091642
cardiovascular diseases	D002318
hemic and lymphatic diseases	D006425
skin and connective tissue diseases	D017437

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Trade Name

FDA

EMA

Cytoxan (generic drugs available since 2008-05-21, discontinued: Cytoxan (lyophilized), Lyophilized cytoxan, Neosar)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Cyclophosphamide

Tradename	Company	Number	Date	Products
CYTOXAN	Baxter	N-012141 RX	1982-01-01	2 products, RLD
CYCLOPHOSPHAMIDE	Eugia Pharma Specialties	N-210735 RX	2021-08-25	2 products, RLD, RS
CYCLOPHOSPHAMIDE	Hikma Pharmaceuticals	N-203856 RX	2013-09-16	2 products, RLD, RS
CYCLOPHOSPHAMIDE	Ingenus	N-212501 RX	2020-07-30	3 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
cyclophosphamide	New Drug Application	2050-01-04

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
b-cell chronic lymphocytic leukemia	—	D015451	C91.1
bcr-abl positive chronic myelogenous leukemia	EFO_0000340	D015464	—
breast neoplasms	EFO_0003869	D001943	C50
burkitt lymphoma	—	D002051	C83.7
endometrial neoplasms	EFO_0004230	D016889	—
ewing sarcoma	EFO_0000173	D012512	—
granulomatosis with polyangiitis	EFO_0005297	D014890	M31.3
hemolytic anemia autoimmune	EFO_1001264	D000744	D59.10
hemosiderosis	—	D006486	—
hodgkin disease	—	D006689	C81

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Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag
Cyclophosphamide, Cyclophosphamide, Ingenus Pharms Llc
10993952	2036-02-15	DP
Cyclophosphamide, Cyclophosphamide, Eugia Pharma Speclts
9662342	2035-06-26	DP

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01A: Alkylating agents

— L01AA: Nitrogen mustard analogues

— L01AA01: Cyclophosphamide

HCPCS

Code	Description
C9087	Injection, cyclophosphamide, (auromedics), 10 mg
J8530	Cyclophosphamide; oral, 25 mg
J9070	Cyclophosphamide, 100 mg

Clinical

Clinical Trials

4701 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	106	355	200	21	72	690
Lymphoma	D008223	—	C85.9	82	262	62	2	31	402
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	118	194	51	18	20	343
Leukemia	D007938	—	C95	72	203	55	2	28	323
Multiple myeloma	D009101	—	C90.0	110	190	37	5	18	314
Non-hodgkin lymphoma	D008228	—	C85.9	113	145	23	5	21	265
Myelodysplastic syndromes	D009190	—	D46	79	174	22	2	22	265
Large b-cell lymphoma diffuse	D016403	—	C83.3	77	134	45	5	6	230
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	60	108	20	3	8	177
Neuroblastoma	D009447	EFO_0000621	—	44	43	21	1	6	106

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	86	138	34	—	15	235
Neoplasms	D009369	—	C80	129	83	6	—	12	187
Melanoma	D008545	—	—	74	78	2	—	3	126
Hodgkin disease	D006689	—	C81	34	83	15	—	10	123
Ovarian neoplasms	D010051	EFO_0003893	C56	56	51	6	—	3	95
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	21	70	9	—	7	94
Sarcoma	D012509	—	—	32	35	13	—	3	75
Hematologic neoplasms	D019337	—	—	25	46	2	—	12	71
Myeloproliferative disorders	D009196	—	D47.1	15	31	2	—	9	52
Non-small-cell lung carcinoma	D002289	—	—	30	25	6	—	—	51

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	26	30	—	—	4	46
Stomach neoplasms	D013274	EFO_0003897	C16	23	11	—	—	1	25
Precursor t-cell lymphoblastic leukemia-lymphoma	D054218	—	—	23	10	—	—	—	24
B-cell lymphoma marginal zone	D018442	—	C88.4	7	15	—	—	2	22
Prostatic neoplasms	D011471	—	C61	17	7	—	—	—	21
Myeloid leukemia chronic-phase	D015466	—	—	5	15	—	—	—	18
Glioblastoma	D005909	EFO_0000515	—	14	6	—	—	—	17
Prolymphocytic leukemia	D015463	—	—	3	14	—	—	1	17
Head and neck neoplasms	D006258	—	—	12	5	—	—	1	15
Uterine cervical neoplasms	D002583	HP_0030159	—	13	9	—	—	—	15

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	4	—	—	—	—	4
Primitive neuroectodermal tumors	D018242	—	—	2	—	—	—	1	3
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	—	—	1	2
Antiphospholipid syndrome	D016736	EFO_0002689	D68.61	1	—	—	—	1	2
Juvenile arthritis	D001171	EFO_1002007	M08	1	—	—	—	1	2
Analgesia	D000698	—	—	2	—	—	—	—	2
Female genital neoplasms	D005833	—	—	1	—	—	—	1	2
Adrenocortical carcinoma	D018268	—	—	2	—	—	—	—	2
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Deltaretrovirus infections	D006800	EFO_1001303	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hemoglobin sc disease	D006450	EFO_1001797	D57.2	—	—	—	—	2	2
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	—	—	—	2	2
Fatigue	D005221	HP_0012378	R53.83	—	—	—	—	2	2
Pure red-cell aplasia	D012010	HP_0012410	—	—	—	—	—	2	2
Trophoblastic neoplasms	D014328	—	—	—	—	—	—	1	1
Taste disorders	D013651	—	—	—	—	—	—	1	1
Dysgeusia	D004408	—	R43.2	—	—	—	—	1	1
Ageusia	D000370	EFO_1001758	—	—	—	—	—	1	1
Ataxia telangiectasia	D001260	Orphanet_100	G11.3	—	—	—	—	1	1
Pregnancy rate	D018873	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Cyclophosphamide
INN	cyclophosphamide
Description	Cyclophosphamide is a phosphorodiamide that is 1,3,2-oxazaphosphinan-2-amine 2-oxide substituted by two 2-chloroethyl groups at the amino nitrogen atom. It has a role as a carcinogenic agent, an alkylating agent, an immunosuppressive agent, an antineoplastic agent, an antirheumatic drug, an environmental contaminant, a xenobiotic and a drug allergen. It is a phosphorodiamide, a nitrogen mustard and an organochlorine compound.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	O.O=P1(N(CCCl)CCCl)NCCCO1