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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YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion 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

102 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	14	11	6	1	2	28
T-cell lymphoma	D016399	—	—	9	7	6	1	2	21
T-cell lymphoma peripheral	D016411	—	—	7	6	6	1	2	19
Non-small-cell lung carcinoma	D002289	—	—	3	2	—	1	1	7
Biliary tract neoplasms	D001661	—	C24.9	—	—	—	1	2	3
Obstructive sleep apnea	D020181	EFO_0003918	G47.33	—	—	—	1	2	3
Syndrome	D013577	—	—	—	—	—	1	2	3
Sleep apnea syndromes	D012891	EFO_0003877	G47.3	—	—	—	1	2	3
Apnea	D001049	—	R06.81	—	—	—	1	1	2
Disease progression	D018450	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	6	5	1	—	—	9
Large-cell lymphoma anaplastic	D017728	—	C84.6	2	2	1	—	—	4
Immunoblastic lymphadenopathy	D007119	EFO_1001350	C86.5	1	2	1	—	—	3
Follicular lymphoma	D008224	—	C82	1	1	1	—	—	2
Atopic dermatitis	D003876	EFO_0000274	L20	—	—	1	—	—	1
Dermatitis	D003872	—	L30.9	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	10	3	—	—	7	18
Breast neoplasms	D001943	EFO_0003869	C50	—	3	—	—	6	9
Lung neoplasms	D008175	—	C34.90	3	2	—	—	1	6
Leukemia	D007938	—	C95	1	1	—	—	3	5
Carcinoma	D002277	—	C80.0	1	3	—	—	1	5
Recurrence	D012008	—	—	1	3	—	—	1	4
Squamous cell carcinoma	D002294	—	—	—	3	—	—	1	4
B-cell lymphoma	D016393	—	—	3	2	—	—	—	4
Mucositis	D052016	EFO_1001898	—	2	1	—	—	—	3
Ovarian neoplasms	D010051	EFO_0003893	C56	2	1	—	—	1	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179	—	—	2	—	—	—	1	3
Squamous cell carcinoma of head and neck	D000077195	—	—	1	—	—	—	2	3
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
Renal cell carcinoma	D002292	EFO_0000376	—	1	—	—	—	1	2
Plasma cell neoplasms	D054219	—	—	1	—	—	—	—	1
Mantle-cell lymphoma	D020522	—	C83.1	1	—	—	—	—	1
Sezary syndrome	D012751	—	C84.1	1	—	—	—	—	1
Primary cutaneous anaplastic large cell lymphoma	D054446	—	C86.6	1	—	—	—	—	1
Melanoma	D008545	—	—	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	—	—	—	—	2	2
Myeloid leukemia	D007951	—	C92	—	—	—	—	2	2
Pancreatic neoplasms	D010190	EFO_0003860	C25	—	—	—	—	2	2
Prostatic neoplasms	D011471	—	C61	—	—	—	—	2	2
Kidney neoplasms	D007680	EFO_0003865	C64	—	—	—	—	2	2
Urogenital neoplasms	D014565	EFO_0003863	D07	—	—	—	—	2	2
Brain neoplasms	D001932	EFO_0003833	C71	—	—	—	—	2	2
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	2	2
Sarcoma	D012509	—	—	—	—	—	—	2	2
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	—	—	—	—	1	1

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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