Cladribine - PharmaKB

Leustatin, Litak(cladribine)

Litak, Mavenclad (cladribine) is a small molecule pharmaceutical. Cladribine was first approved as Leustatin on 1993-02-26. It is used to treat b-cell chronic lymphocytic leukemia, hairy cell leukemia, multiple sclerosis, and non-hodgkin lymphoma in the USA. It has been approved in Europe to treat hairy cell leukemia and multiple sclerosis.

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Events

FDA approval date

EMA approval date

Patent expiration date

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
nervous system diseases	D009422
hemic and lymphatic diseases	D006425
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Mavenclad (generic drugs available since 2000-02-28, discontinued: Leustatin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Cladribine

Tradename	Company	Number	Date	Products
MAVENCLAD	EMD Serono	N-022561 RX	2019-03-29	1 products, RLD, RS

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FDA

EMA

Brand Name	Status	Last Update
cladribine	ANDA	2023-04-19
mavenclad	New Drug Application	2023-12-14

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
b-cell chronic lymphocytic leukemia	—	D015451	C91.1
hairy cell leukemia	—	D007943	C91.4
multiple sclerosis	EFO_0003885	D009103	G35
non-hodgkin lymphoma	—	D008228	C85.9

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Cladribine, Mavenclad, Emd Serono Inc
10849919	2038-11-23		U-3411
7713947	2026-10-16		U-2520
8377903	2026-05-31		U-2522
7888328	2024-04-11	DP	U-2521
8785415	2024-04-11	DP	U-2523

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01B: Antimetabolites

— L01BB: Purine analogs, antimetabolites antineoplastic

— L01BB04: Cladribine

— L04: Immunosuppressants

— L04A: Immunosuppressants

— L04AA: Selective immunosuppressants

— L04AA40: Cladribine

HCPCS

Code	Description
J9065	Injection, cladribine, per 1 mg

Clinical

Clinical Trials

187 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple sclerosis	D009103	EFO_0003885	G35	2	3	5	8	14	30
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	1	4	1	2	4	11
Relapsing-remitting multiple sclerosis	D020529	EFO_0003929	—	—	—	4	2	4	10

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	20	30	10	—	6	54
Myelodysplastic syndromes	D009190	—	D46	9	14	2	—	2	21
Leukemia	D007938	—	C95	6	11	1	—	—	17
Lymphoma	D008223	—	C85.9	3	4	1	—	—	8
Myelomonocytic leukemia chronic	D015477	—	C93.1	3	4	1	—	—	7
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	2	3	1	—	2	7
Hairy cell leukemia	D007943	—	C91.4	—	4	1	—	—	4
Langerhans-cell histiocytosis	D006646	—	C96.6	—	2	1	—	—	2
Systemic mastocytosis	D034721	—	C96.21	—	1	2	—	—	2
Myeloid leukemia	D007951	—	C92	—	1	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Eyelid neoplasms	D005142	EFO_1000934	—	2	3	—	—	—	5
Biphenotypic leukemia acute	D015456	—	C95.0	4	4	—	—	—	5
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	—	3	—	—	2	5
Non-hodgkin lymphoma	D008228	—	C85.9	—	2	—	—	2	4
Mantle-cell lymphoma	D020522	—	C83.1	1	1	—	—	1	3
Hodgkin disease	D006689	—	C81	—	1	—	—	2	3
Breast neoplasms	D001943	EFO_0003869	C50	1	1	—	—	1	3
Urinary bladder neoplasms	D001749	—	C67	—	2	—	—	—	2
Precursor t-cell lymphoblastic leukemia-lymphoma	D054218	—	—	—	1	—	—	1	2
Hematologic neoplasms	D019337	—	—	1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Recurrence	D012008	—	—	1	—	—	—	—	1
Lymphoproliferative disorders	D008232	Orphanet_2442	D47.9	1	—	—	—	—	1
Central nervous system neoplasms	D016543	—	—	1	—	—	—	—	1
Myeloproliferative disorders	D009196	—	D47.1	1	—	—	—	—	1
Plasma cell neoplasms	D054219	—	—	1	—	—	—	—	1
Triple negative breast neoplasms	D064726	—	—	1	—	—	—	—	1
Burkitt lymphoma	D002051	—	C83.7	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101	—	C90.0	—	—	—	—	2	2
Aplastic anemia	D000741	HP_0001915	D61.9	—	—	—	—	2	2
Paroxysmal hemoglobinuria	D006457	Orphanet_447	D59.12	—	—	—	—	2	2
Prediabetic state	D011236	EFO_1001121	R73.03	—	—	—	—	2	2
Medication adherence	D055118	EFO_0006344	—	—	—	—	—	1	1
Renal cell carcinoma	D002292	EFO_0000376	—	—	—	—	—	1	1
Ovarian neoplasms	D010051	EFO_0003893	C56	—	—	—	—	1	1
Sarcoma	D012509	—	—	—	—	—	—	1	1
Melanoma	D008545	—	—	—	—	—	—	1	1
Waldenstrom macroglobulinemia	D008258	HP_0005508	C88.0	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Cladribine
INN	cladribine
Description	Cladribine is 2'-Deoxyadenosine in which the hydrogen at position 2 on the purine ring has been substituted by chlorine. It inhibits the synthesis and repair of DNA, particularly in lymphocytes and monocytes, and is used as an antimetabolite antineoplastic drug for the treatment of lymphoid malignancies including hairy-cell leukaemia and chronic lymphocytic leukaemia. It has a role as an antineoplastic agent and an immunosuppressive agent. It is a purine 2'-deoxyribonucleoside and an organochlorine compound.
Classification	Small molecule
Drug class	ribofuranil derivatives (pyrazofurin type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Nc1nc(Cl)nc2c1ncn2[C@H]1C[C@H](O)[C@@H](CO)O1