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mitapivat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| pyruvate kinase activators | 5506 | 2151847-10-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Mitapivat is a pyruvate kinase activator that acts by allosterically binding to the pyruvate kinase tetramer and increasing pyruvate kinase (PK) activity. The red blood cell (RBC) form of pyruvate kinase (PK-R) is mutated in PK deficiency, which leads to reduced adenosine triphosphate(ATP), shortened RBC lifespan, and chronic hemolysis.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK8,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ZAP70 | 47 | |||
| kinase-selectivity-class | AXL,ERBB2,GRK2,IKBKB,MAPK7,MAPK8,MAPKAPK2,PDK1,PDK4,SIK2,STK33,TEK,ULK1 | 13 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 17, 2022 | FDA | AGIOS PHARMACEUTICALS INC | |
| Nov. 9, 2022 | EMA | AGIOS NETHERLANDS B.V. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Haemoglobin decreased | 54.36 | 44.33 | 17 | 75 | 132454 | 42488789 |
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | B06AX04 | BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Other hematological agents |
| MeSH PA | D020536 | Enzyme Activators |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000185507 | Cytochrome P450 2C9 Inducers |
| FDA MoA | N0000185607 | Cytochrome P450 2C19 Inducers |
| FDA MoA | N0000187063 | Cytochrome P450 2C8 Inducers |
| FDA MoA | N0000187064 | Cytochrome P450 2B6 Inducers |
| FDA MoA | N0000190118 | Cytochrome P450 3A Inducers |
| FDA EPC | N0000194008 | Pyruvate Kinase Activator |
| FDA MoA | N0000194009 | Pyruvate Kinase Activators |
| FDA MoA | N0000194036 | UGT1A1 Inducers |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
Related Drugs by ATC class:
B06AX Other hematological agents 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pyruvate kinase (PK) deficiency | indication | 124331002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | 10632114 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR TREATING ANEMIA IN ADULTS WITH ALPHA OR BETA THALASSEMIA |
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | 9682080 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF ANEMIA IN ADULTS WITH ALPHA OR BETA THALASSEMIA |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 10632114 | May 3, 2032 | METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9682080 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9980961 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 10632114 | May 3, 2032 | METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9682080 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9980961 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 10632114 | May 3, 2032 | METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9682080 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9980961 | May 3, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | 9193701 | Oct. 26, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR INCREASING RED BLOOD CELL LONGEVITY IN ADULTS WITH ALPHA OR BETA THALASSEMIA |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9193701 | Oct. 26, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9193701 | Oct. 26, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 9193701 | Oct. 26, 2032 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11793806 | April 12, 2033 | METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11793806 | April 12, 2033 | METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11793806 | April 12, 2033 | METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11234976 | Oct. 11, 2038 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY BY ADMINISTERING A DAILY DOSE OF 10MG TO 100MG |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11234976 | Oct. 11, 2038 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY BY ADMINISTERING A DAILY DOSE OF 10MG TO 100MG |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11234976 | Oct. 11, 2038 | METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY BY ADMINISTERING A DAILY DOSE OF 10MG TO 100MG |
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | 11878049 | July 31, 2041 | METHOD FOR USING A PYRUVATE KINASE ACTIVATOR TO MITIGATE DRUG INTERACTIONS IN ADULTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11878049 | July 31, 2041 | METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11878049 | July 31, 2041 | METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | 11878049 | July 31, 2041 | METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | Feb. 17, 2027 | NEW CHEMICAL ENTITY |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | Feb. 17, 2027 | NEW CHEMICAL ENTITY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | Feb. 17, 2027 | NEW CHEMICAL ENTITY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | Feb. 17, 2027 | NEW CHEMICAL ENTITY |
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | Dec. 23, 2028 | NEW PRODUCT |
| EQ 20MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | Feb. 17, 2029 | TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 50MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | Feb. 17, 2029 | TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 5MG BASE | PYRUKYND | AGIOS PHARMS INC | N216196 | Feb. 17, 2022 | RX | TABLET | ORAL | Feb. 17, 2029 | TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| EQ 100MG BASE | AQVESME | AGIOS PHARMS INC | N216196 | Dec. 23, 2025 | RX | TABLET | ORAL | Dec. 23, 2032 | TREATMENT OF ANEMIA IN ADULTS WITH ALPHA-OR BETA-THALASSEMIA |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Pyruvate kinase PKLR | Enzyme | ACTIVATOR | AC50 | 7.89 | DRUG LABEL | DRUG LABEL | |||
| Pyruvate kinase PKM | Enzyme | ACTIVATOR | AC50 | 7.42 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 1260075-17-9 | SECONDARY_CAS_RN |
| CHEBI:757622 | CHEBI |
| WV2 | PDB_CHEM_ID |
| CHEMBL4299940 | ChEMBL_ID |
| C000634504 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10473 | IUPHAR_LIGAND_ID |
| DB16236 | DRUGBANK_ID |
| 42782611000001109 | SNOMEDCT_US |
| 44102311000001100 | SNOMEDCT_US |
| 4041222 | VANDF |
| C5226639 | UMLSCUI |
| CHEMBL4297223 | ChEMBL_ID |
| D11408 | KEGG_DRUG |
| 10226 | INN_ID |
| 59634741 | PUBCHEM_CID |
| 357746 | MMSL |
| 40529 | MMSL |
| 40563 | MMSL |
| d09864 | MMSL |
| 018958 | NDDF |
| 018959 | NDDF |
| 2WTV10SIKH | UNII |
| 2594468 | RXNORM |
| 2WTV10SIKH | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PYRUKYND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71334-205 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 27 sections |
| PYRUKYND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71334-210 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 27 sections |
| PYRUKYND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71334-215 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 27 sections |
| PYRUKYND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71334-220 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 27 sections |
| AQVESME | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71334-235 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 26 sections |