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Drug ReportsPralatrexate
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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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Folotyn, Pralatrexate
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pralatrexate
Tradename
Company
Number
Date
Products
FOLOTYNAcrotech BiopharmaN-022468 RX2009-09-24
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
folotynNew Drug Application2024-09-26
histex pdx dropsC2002632024-01-08
pralatrexateNDA authorized generic2022-11-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
t-cell lymphoma peripheralD016411
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Pralatrexate, Folotyn, Acrotech Biopharma
76224702025-05-31U-1015
82990782025-05-31U-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
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.910631218
T-cell lymphoma peripheralD0164115661217
T-cell lymphomaD0163997541216
Non-small-cell lung carcinomaD00228932117
Biliary tract neoplasmsD001661C24.9134
Obstructive sleep apneaD020181EFO_0003918G47.33123
SyndromeD013577123
Sleep apnea syndromesD012891EFO_0003877G47.3123
ApneaD001049R06.81112
Disease progressionD01845011
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8092717
RecurrenceD01200857211
Breast neoplasmsD001943EFO_0003869C50369
LeukemiaD007938C952135
Neoplasm metastasisD009362EFO_0009708325
Lung neoplasmsD008175C34.901214
Squamous cell carcinomaD002294213
Mycosis fungoidesD009182C84.0313
Ovarian neoplasmsD010051EFO_0003893C562113
B-cell lymphomaD016393223
Show 22 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179224
Kidney neoplasmsD007680EFO_0003865C64123
Squamous cell carcinoma of head and neckD000077195123
Sezary syndromeD012751C84.122
T-cell lymphoma cutaneousD016410C84.A22
MucositisD052016EFO_100189822
Renal cell carcinomaD002292EFO_0000376112
MelanomaD00854522
Plasma cell neoplasmsD05421911
T-cell leukemiaD01545811
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.022
Myeloid leukemiaD007951C9222
Pancreatic neoplasmsD010190EFO_0003860C2522
Prostatic neoplasmsD011471C6122
Urogenital neoplasmsD014565EFO_0003863D0722
Brain neoplasmsD001932EFO_0003833C7122
Pre-eclampsiaD011225EFO_0000668O1422
SarcomaD01250922
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011
Acute diseaseD00020811
Show 55 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePralatrexate
INNpralatrexate
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 classantimetabolites (folic acid derivatives)
Image (chem structure or protein)Loading
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
Identifiers
PDB
CAS-ID146464-95-1
RxCUI
ChEMBL IDCHEMBL1201746
ChEBI ID71223
PubChem CID148121
DrugBankDB06813
UNII IDA8Q8I19Q20 (ChemIDplus, GSRS)
Target
Agency Approved
DHFR
DHFR
Organism
Homo sapiens
Gene name
DHFR
Gene synonyms
NCBI Gene ID
Protein name
dihydrofolate reductase
Protein synonyms
Uniprot ID
Mouse ortholog
Dhfr (13361)
dihydrofolate reductase (Q61579)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Folotyn Spectrum Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,915 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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705 adverse events reported
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