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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Trade Name
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Folotyn
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
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 | 2023-06-05 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J9307 | Injection, pralatrexate, 1 mg |
Clinical
Clinical Trials
592 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Surgical wound infection | D013530 | — | 7 | 10 | 11 | 17 | 43 | ||
| Gingivitis | D005891 | K05.10 | 1 | 4 | 6 | 6 | 12 | 29 | |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 4 | 3 | 9 | 9 | 25 |
| Infections | D007239 | EFO_0000544 | 1 | 1 | 5 | 5 | 13 | 25 | |
| Covid-19 | D000086382 | U07.1 | 4 | 8 | 1 | 4 | 5 | 20 | |
| Periodontal diseases | D010510 | K05.6 | — | 2 | 3 | 3 | 13 | 19 | |
| Dental caries | D003731 | EFO_0003819 | K02 | 2 | 2 | 7 | 1 | 8 | 19 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | 2 | 2 | 4 | 1 | 7 | 16 |
| Dental plaque | D003773 | 3 | 3 | 3 | 3 | 6 | 16 | ||
| Bacteremia | D016470 | EFO_0003033 | R78.81 | 1 | — | 1 | 5 | 6 | 13 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | 1 | 2 | 1 | — | 4 | 6 |
| Wounds and injuries | D014947 | T14.8 | — | — | 1 | — | 3 | 4 | |
| Neonatal sepsis | D000071074 | HP_0040187 | — | 1 | 1 | — | 2 | 3 | |
| Infant mortality | D007226 | — | — | 2 | — | 1 | 3 | ||
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | — | — | 1 | — | 2 | 3 |
| Postoperative complications | D011183 | — | — | 2 | — | 1 | 3 | ||
| Communicable diseases | D003141 | — | — | 2 | — | 1 | 3 | ||
| Esophageal neoplasms | D004938 | C15 | — | 1 | 1 | — | 2 | 3 | |
| Respiratory tract infections | D012141 | J06.9 | 1 | 1 | 2 | — | — | 3 | |
| Neoplasms | D009369 | C80 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Halitosis | D006209 | R19.6 | 1 | 1 | — | — | 3 | 4 | |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 3 | — | — | — | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 2 | 3 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | 2 | 2 | — | — | 1 | 3 | |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 1 | — | — | — | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 1 | — | — | — | 2 |
| Cesarean section | D002585 | — | 1 | — | — | 1 | 2 | ||
| Oropharyngeal neoplasms | D009959 | — | 1 | — | — | 1 | 2 | ||
| Fever | D005334 | HP_0001945 | R50.9 | 1 | 1 | — | — | — | 1 |
| Warts | D014860 | B07 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | 1 | — | — | — | 1 | 2 | ||
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | 1 | 2 |
| Cerebral hemorrhage | D002543 | 1 | — | — | — | — | 1 | ||
| Ingrown nails | D009263 | L60.0 | 1 | — | — | — | — | 1 | |
| Rhinoplasty | D012225 | 1 | — | — | — | — | 1 | ||
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary heart disease | D011660 | I27.81 | 1 | — | — | — | — | 1 | |
| Diabetic angiopathies | D003925 | EFO_1000896 | 1 | — | — | — | — | 1 | |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 1 | — | — | — | — | 1 |
| Stomatognathic diseases | D009057 | K08.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hydrogen-ion concentration | D006863 | — | — | — | — | 3 | 3 | ||
| Coronary disease | D003327 | — | — | — | — | 2 | 2 | ||
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 2 | 2 |
| Abscess | D000038 | EFO_0003030 | — | — | — | — | 2 | 2 | |
| Furunculosis | D005667 | L02.92 | — | — | — | — | 2 | 2 | |
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | — | — | — | 2 | 2 |
| Rosacea | D012393 | L71 | — | — | — | — | 2 | 2 | |
| Risk reduction behavior | D040242 | — | — | — | — | 2 | 2 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 2 | 2 |
| Cicatrix | D002921 | HP_0100699 | L90.5 | — | — | — | — | 2 | 2 |
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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 |
Identifiers
| PDB | — |
| CAS-ID | 146464-95-1 |
| RxCUI | 662019 |
| ChEMBL ID | CHEMBL1201746 |
| ChEBI ID | 71223 |
| PubChem CID | 148121 |
| DrugBank | DB06813 |
| UNII ID | A8Q8I19Q20 (ChemIDplus, GSRS) |
Target
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Financial
Folotyn - Spectrum Pharmaceuticals
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Safety
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Adverse Events
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1,411 adverse events reported
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