Mitapivat information

Mitapivat
Clinical data
Trade names	Pyrukynd
Other names	AG-348, Mitapivat sulfate (USAN US)
License data	US DailyMed: Mitapivat;
Routes of; administration	By mouth
ATC code	B06AX04 (WHO) ;
Legal status
Legal status	US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	1260075-17-9;
PubChem CID	59634741;
IUPHAR/BPS	10473;
DrugBank	DB16236; as salt: DBSALT003215;
ChemSpider	29763395;
UNII	2WTV10SIKH; as salt: N4JTA67V3O;
KEGG	as salt: D11408;
ChEMBL	ChEMBL4299940; as salt: ChEMBL4297223;
Chemical and physical data
Formula	C24H26N4O3S
Molar mass	450.56 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES O=C(N1CCN(CC2CC2)CC1)C1=CC=C(NS(=O)(=O)C2=CC=CC3=C2N=CC=C3)C=C1;
	InChI InChI=1S/C24H26N4O3S/c29-24(28-15-13-27(14-16-28)17-18-6-7-18)20-8-10-21(11-9-20)26-32(30,31)22-5-1-3-19-4-2-12-25-23(19)22/h1-5,8-12,18,26H,6-7,13-17H2; Key:XAYGBKHKBBXDAK-UHFFFAOYSA-N;

Mitapivat, sold under the brand name Pyrukynd, is a medication used to treat hemolytic anemia.^[1] It is taken as the sulfate hydrate salt by mouth.^[1] Mitapivat is a pyruvate kinase activator.^[1]

The most common side effects include decreases in estrone and estradiol (types of the estrogen hormone) in men, increased urate (a type of salt in the body), back pain, and joint stiffness.^[3]

Mitapivat was approved for medical use in the United States in February 2022,^[1]^[3]^[4]^[5] and in the European Union in November 2022.^[2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^[6]^[7]

^ ^a ^b ^c ^d ^e "Pyrukynd- mitapivat tablet, film coated Pyrukynd- mitapivat kit". DailyMed. 23 February 2022. Archived from the original on 3 March 2022. Retrieved 3 March 2022.
^ ^a ^b Cite error: The named reference Pyrukynd EPAR was invoked but never defined (see the help page).
^ ^a ^b "Drug Trials Snapshot: Pyrukynd". U.S. Food and Drug Administration (FDA). 1 June 2023. Retrieved 1 June 2023. This article incorporates text from this source, which is in the public domain.
^ "Agios Announces FDA Approval of Pyrukynd (mitapivat) as First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency" (Press release). Agios Pharmaceuticals. 17 February 2022. Archived from the original on 20 February 2022. Retrieved 19 February 2022 – via GlobeNewswire.
^ Gormley N. "Pyrukynd (mitapivat) tablets NDA approval" (PDF). Center for Drug Evaluation and Research. Letter to Christina Baladi (Agios Pharmaceuticals, Inc.). U.S. Food and Drug Administration.
^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.

[Pyrukynd_FDA_label-1] "Pyrukynd- mitapivat tablet, film coated Pyrukynd- mitapivat kit". DailyMed. 23 February 2022. Archived from the original on 3 March 2022. Retrieved 3 March 2022.

[Pyrukynd_EPAR-2] Cite error: The named reference Pyrukynd EPAR was invoked but never defined (see the help page).

[Drug_Trials_Snapshot:_Pyrukynd-3] "Drug Trials Snapshot: Pyrukynd". U.S. Food and Drug Administration (FDA). 1 June 2023. Retrieved 1 June 2023. This article incorporates text from this source, which is in the public domain.

[Agios_PR-4] "Agios Announces FDA Approval of Pyrukynd (mitapivat) as First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency" (Press release). Agios Pharmaceuticals. 17 February 2022. Archived from the original on 20 February 2022. Retrieved 19 February 2022 – via GlobeNewswire.

[FDA_approval_letter-5] Gormley N. "Pyrukynd (mitapivat) tablets NDA approval" (PDF). Center for Drug Evaluation and Research. Letter to Christina Baladi (Agios Pharmaceuticals, Inc.). U.S. Food and Drug Administration.

[New_Drug_Therapy_Approvals_2022-6] "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.

[7] New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.

Mitapivat information

and 5 Related for: Mitapivat information

Mitapivat

Agios Pharmaceuticals

Hemolytic anemia

ATC code B06

Pyruvate kinase deficiency