US 11878049

US Patent 11878049 Summary

Title: Mitapivat therapy and modulators of cytochrome P450

Assignee: Agios Pharmaceuticals Inc.

Inventors: Varsha Venkatachalam Iyer, Chandra Agarwal Prakash, Hua Yang

Filing Date: 2020-06-12

Issue Date: 2024-01-23

Abstract: The patent describes methods for treating diseases, disorders, or conditions using mitapivat or its pharmaceutically acceptable salts. These methods involve either co-administering mitapivat with a cytochrome P450 3A4/5 (CYP3A4/5) inducer, a CYP3A4/5 inhibitor, or a p-glycoprotein (p-gp) inhibitor, or administering mitapivat in the absence of such modulators. The disclosure provides for adjusting the mitapivat dosage to manage drug-drug interactions when co-administered with CYP3A4/5 modulators or p-gp inhibitors. Diseases targeted include pyruvate kinase deficiency (PKD), sickle cell disease, and thalassemia.

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Plain-Language Overview of Independent Claims:

• Claim 1: This claim covers a method to treat pyruvate kinase deficiency (PKD) by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a drug that increases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 16: This claim outlines a method to treat PKD by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a drug that increases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 22: This claim describes a method to treat PKD by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a drug that decreases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 37: This claim covers a method to treat PKD by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a drug that decreases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 43: This claim describes a method to treat sickle cell disease by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a drug that increases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 50: This claim outlines a method to treat sickle cell disease by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a drug that increases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 54: This claim covers a method to treat sickle cell disease by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a drug that decreases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 61: This claim describes a method to treat sickle cell disease by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a drug that decreases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 65: This claim outlines a method to treat thalassemia by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a drug that increases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 74: This claim covers a method to treat thalassemia by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a drug that increases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 80: This claim describes a method to treat thalassemia by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a drug that decreases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 89: This claim outlines a method to treat thalassemia by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a drug that decreases the activity of CYP3A4 or CYP3A5 enzymes.
• Claim 95: This claim covers a method to treat PKD by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a p-glycoprotein inhibitor.
• Claim 102: This claim describes a method to treat PKD by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a p-glycoprotein inhibitor.
• Claim 108: This claim outlines a method to treat sickle cell disease by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a p-glycoprotein inhibitor.
• Claim 113: This claim covers a method to treat sickle cell disease by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a p-glycoprotein inhibitor.
• Claim 117: This claim describes a method to treat thalassemia by giving a patient an effective amount of mitapivat (or a salt form) along with an effective amount of a p-glycoprotein inhibitor.
• Claim 124: This claim outlines a method to treat thalassemia by giving a patient an effective amount of mitapivat (or a salt form) without also giving them a p-glycoprotein inhibitor.

CAFC 2026 Dockets: As of April 26, 2026, no specific dockets related to US patent 11878049 were found in the 2026 filings of the U.S. Court of Appeals for the Federal Circuit.