Pyrukynd(mitapivat)
Pyrukynd (mitapivat) is a small molecule pharmaceutical. Mitapivat was first approved as Pyrukynd on 2022-02-17. It is used to treat hemolytic anemia in the USA. It has been approved in Europe to treat hemolytic anemia and inborn genetic diseases. It is known to target pyruvate kinase PKM.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Pyrukynd
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mitapivat sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PYRUKYND | Agios Pharmaceuticals | N-216196 RX | 2022-02-17 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pyrukynd | New Drug Application | 2024-10-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemolytic anemia | — | D000743 | D55-D59 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MITAPIVAT SULFATE, PYRUKYND, AGIOS PHARMS INC | |||
| 2029-02-17 | ODE-392 | ||
| 2027-02-17 | NCE | ||
Patent Expiration
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inborn errors pyruvate metabolism | D015323 | — | — | — | 1 | 5 | 1 | 2 | 9 |
| Hemolytic anemia | D000743 | — | D55-D59 | 1 | 1 | 4 | 1 | 1 | 7 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemolytic anemia congenital nonspherocytic | D000746 | — | — | — | 1 | 5 | — | 2 | 8 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 3 | 1 | — | 1 | 5 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | 1 | 2 | — | 1 | 4 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | — | 2 | — | 1 | 3 |
| Alpha-thalassemia | D017085 | Orphanet_846 | D56.0 | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemolysis | D006461 | — | — | 1 | 1 | — | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | — | 10 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mitapivat |
| INN | mitapivat |
| Description | Mitapivat, sold under the brand name Pyrukynd, is a medication used to treat hemolytic anemia. It is taken as the sulfate hydrate salt by mouth. Mitapivat is a pyruvate kinase activator.
|
| Classification | Small molecule |
| Drug class | pyruvate kinase activators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(c1ccc(NS(=O)(=O)c2cccc3cccnc23)cc1)N1CCN(CC2CC2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1260075-17-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4299940 |
| ChEBI ID | — |
| PubChem CID | 59634741 |
| DrugBank | DB16236 |
| UNII ID | 2WTV10SIKH (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PKM
PKM
Organism
Homo sapiens
Gene name
PKM
Gene synonyms
OIP3, PK2, PK3, PKM2
NCBI Gene ID
Protein name
pyruvate kinase PKM
Protein synonyms
CTHBP, Cytosolic thyroid hormone-binding protein, epididymis secretory protein Li 30, OIP-3, OPA-interacting protein 3, p58, PK, muscle type, Pyruvate kinase 2/3, pyruvate kinase isozymes M1/M2, Pyruvate kinase muscle isozyme, pyruvate kinase, muscle, THBP1, Threonine-protein kinase PKM2, Thyroid hormone-binding protein 1, thyroid hormone-binding protein, cytosolic, Tumor M2-PK, Tyrosine-protein kinase PKM2
Uniprot ID
Mouse ortholog
Pkm (18746)
pyruvate kinase PKM (P52480)
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 198 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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349 adverse events reported
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