Pralatrexate - PharmaKB

Pralatrexate

Folotyn, Pralatrexate (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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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start 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, Pralatrexate

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

Brand Name	Status	Last Update
folotyn	New Drug Application	2024-09-26
histex pdx drops	C200263	2024-01-08
pralatrexate	NDA authorized generic	2022-11-15

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

105 clinical trials

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Indications Phases 4

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Indications Phases 3

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

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	4	2	—	—	—	5
Recurrence	D012008	—	—	3	2	—	—	—	4
T-cell lymphoma	D016399	—	—	3	2	—	—	—	4
Neoplasm metastasis	D009362	EFO_0009708	—	—	2	—	—	—	2
Non-hodgkin lymphoma	D008228	—	C85.9	2	1	—	—	—	2
Breast neoplasms	D001943	EFO_0003869	C50	—	1	—	—	—	1
Carcinoma	D002277	—	C80.0	—	1	—	—	—	1
Urinary bladder neoplasms	D001749	—	C67	—	1	—	—	—	1
Transitional cell carcinoma	D002295	—	—	—	1	—	—	—	1
Leukemia	D007938	—	C95	1	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sezary syndrome	D012751	—	C84.1	2	—	—	—	—	2
Mycosis fungoides	D009182	—	C84.0	2	—	—	—	—	2
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
Mucositis	D052016	EFO_1001898	—	2	—	—	—	—	2
Primary cutaneous anaplastic large cell lymphoma	D054446	—	C86.6	1	—	—	—	—	1
Non-small-cell lung carcinoma	D002289	—	—	1	—	—	—	—	1
Lung neoplasms	D008175	—	C34.90	1	—	—	—	—	1

Indications Without Phase

No data

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