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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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)
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 | 2024-09-26 |
| 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
HCPCS
Code | Description |
|---|---|
| J9307 | Injection, pralatrexate, 1 mg |
Clinical
Clinical Trials
41 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 | 11 | 11 | 6 | 1 | 2 | 25 |
| T-cell lymphoma | D016399 | — | — | 9 | 7 | 6 | 1 | 2 | 21 |
| T-cell lymphoma peripheral | D016411 | — | — | 7 | 6 | 6 | 1 | 2 | 19 |
| 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 | 4 | 5 | 1 | — | — | 7 |
| 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 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 2 | — | — | — | 5 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | 1 | 3 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | 1 | 3 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 3 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 2 | — | — | — | 3 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | 2 | — | — | — | 3 |
| Mucositis | D052016 | EFO_1001898 | — | 2 | 1 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 1 | — | — | — | 2 |
| T-cell leukemia | D015458 | — | — | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| T-cell lymphoma cutaneous | D016410 | — | — | 2 | — | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | 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 | — | — | — | — | — | — | 1 | 1 |
| Myeloid leukemia | D007951 | — | C92 | — | — | — | — | 1 | 1 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 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 |
Identifiers
| PDB | — |
| CAS-ID | 146464-95-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201746 |
| ChEBI ID | 71223 |
| PubChem CID | 148121 |
| DrugBank | DB06813 |
| UNII ID | A8Q8I19Q20 (ChemIDplus, GSRS) |
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Folotyn – Spectrum Pharmaceuticals
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Safety
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Adverse Events
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663 adverse events reported
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