Gavreto(pralsetinib)
Gavreto (pralsetinib) is a small molecule pharmaceutical. Pralsetinib was first approved as Gavreto on 2020-09-04. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against proto-oncogene tyrosine-protein kinase receptor Ret. In addition, it is known to target vascular endothelial growth factor receptor 2.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Gavreto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pralsetinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GAVRETO | Rigel Pharmaceuticals | N-213721 RX | 2020-09-04 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gavreto | New Drug Application | 2024-11-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PRALSETINIB, GAVRETO, BLUEPRINT MEDICINES | |||
| 2027-12-01 | ODE-340, ODE-341 | ||
| 2027-09-04 | ODE-318 | ||
| 2025-09-04 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
16 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 |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 2 | 1 | — | 1 | 4 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | 1 | 1 | — | — | 2 |
| Neuroendocrine carcinoma | D018278 | — | — | 1 | 1 | 1 | — | — | 2 |
| Papillary thyroid cancer | D000077273 | — | — | 1 | 1 | 1 | — | — | 2 |
| Thyroid diseases | D013959 | — | E00-E07 | 1 | 1 | 1 | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | 1 | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | 1 | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | 1 | 1 | 1 | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 1 | 1 | — | — | 2 |
| Respiratory tract diseases | D012140 | — | — | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | 1 | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 1 | 1 | — | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | 1 | 1 | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | 1 | 1 | — | — | — | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | 1 | — | — | — | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | 1 | — | — | — | 1 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | 1 | — | — | — | 1 |
| Endocrine gland neoplasms | D004701 | EFO_0003769 | D35 | 1 | 1 | — | — | — | 1 |
| Glandular and epithelial neoplasms | D009375 | — | — | 1 | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pralsetinib |
| INN | pralsetinib |
| Description | Pralsetinib, sold under the brand name Gavreto, is a medication approved for RET mutation-positive medullary thyroid cancer (MTC) and RET fusion-positive differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) therapy. Pralsetinib is a tyrosine kinase inhibitor. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CO[C@]1(C(=O)N[C@@H](C)c2ccc(-n3cc(F)cn3)nc2)CC[C@H](c2nc(C)cc(Nc3cc(C)[nH]n3)n2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 2097132-93-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4582651 |
| ChEBI ID | — |
| PubChem CID | 129073603 |
| DrugBank | DB15822 |
| UNII ID | 1WPE73O1WV (ChemIDplus, GSRS) |
Target
Agency Approved
RET
RET
Organism
Homo sapiens
Gene name
RET
Gene synonyms
CDHF12, CDHR16, PTC, RET51
NCBI Gene ID
Protein name
proto-oncogene tyrosine-protein kinase receptor Ret
Protein synonyms
Cadherin family member 12, cadherin-related family member 16, Proto-oncogene c-Ret, rearranged during transfection, ret proto-oncogene (multiple endocrine neoplasia and medullary thyroid carcinoma 1, Hirschsprung disease), RET receptor tyrosine kinase
Uniprot ID
Mouse ortholog
Ret (19713)
proto-oncogene tyrosine-protein kinase receptor Ret (P35546)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Gavreto – Blueprint Medicines
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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 1,202 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,405 adverse events reported
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