Pralatrexate - PharmaKB

Pralatrexate

Folotyn (pralatrexate) is a small molecule pharmaceutical. Pralatrexate was first approved as Folotyn on 2009-09-24. It is used to treat t-cell lymphoma peripheral in the USA. The pharmaceutical is active against dihydrofolate reductase.

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Patent expiration date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
immune system diseases	D007154

Trade Name

FDA

EMA

Folotyn

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Pralatrexate

Tradename	Company	Number	Date	Products
FOLOTYN	Acrotech Biopharma	N-022468 RX	2009-09-24	2 products, RLD, RS

Labels

FDA

EMA

No data

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
t-cell lymphoma peripheral	—	D016411	—

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	FDA Information
Pralatrexate, Folotyn, Acrotech Biopharma
7622470	2025-05-31	U-1015
8299078	2025-05-31	U-1004

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01B: Antimetabolites

— L01BA: Folic acid analogs, antimetabolites

— L01BA05: Pralatrexate

HCPCS

Code	Description
J9307	Injection, pralatrexate, 1 mg

Clinical

Clinical Trials

39 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
T-cell lymphoma peripheral	D016411	—	—	5	6	4	1	1	14
Disease progression	D018450	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
T-cell lymphoma	D016399	—	—	2	1	1	—	—	3

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	3	2	—	—	—	3
Multiple myeloma	D009101	—	C90.0	2	1	—	—	—	2
Adenocarcinoma	D000230	—	—	—	2	—	—	—	2
Squamous cell carcinoma	D002294	—	—	—	2	—	—	—	2
Non-small-cell lung carcinoma	D002289	—	—	1	1	—	—	—	2
Large-cell lymphoma anaplastic	D017728	—	C84.6	1	2	—	—	—	2
Mycosis fungoides	D009182	—	C84.0	2	1	—	—	—	2
B-cell lymphoma	D016393	—	—	1	2	—	—	—	2
Hodgkin disease	D006689	—	C81	2	2	—	—	—	2
Lymphoma	D008223	—	C85.9	2	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	3	—	—	—	—	3
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
T-cell leukemia	D015458	—	—	1	—	—	—	—	1
Sezary syndrome	D012751	—	C84.1	1	—	—	—	—	1
Primary cutaneous anaplastic large cell lymphoma	D054446	—	C86.6	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	—	—	—	—	1	1
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Pralatrexate
INN	pralatrexate
Description	Pralatrexate is a pteridine that is the N-4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl derivative of L-glutamic acid. Used for treatment of Peripheral T-Cell Lymphoma, an aggressive form of non-Hodgkins lymphoma. It has a role as an antineoplastic agent, an antimetabolite and an EC 1.5.1.3 (dihydrofolate reductase) inhibitor. It is a N-acyl-L-glutamic acid, a member of pteridines and a terminal acetylenic compound.
Classification	Small molecule
Drug class	antimetabolites (folic acid derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C#CCC(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1