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Last Updated: December 16, 2025

Claims for Patent: 11,324,734


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Summary for Patent: 11,324,734
Title:Compositions and methods for treating anemia
Abstract:Provided herein are specific doses of, and dosing regimens for, using a HIF prolyl hydroxylase inhibitor in treating or preventing anemia, such as anemia secondary to or associated with chronic kidney disease, anemia secondary to or associated with non-dialysis dependent chronic kidney disease anemia associated with or resulting from chemotherapy, or anemia associated with AIDS.
Inventor(s):Alexander Smith, Gurudatt Ajay Chandorkar, Ene Ikpong Ette, Bradley John Maroni, Charlotte Suzanne Hartman, Ramin Farzaneh-Far, Jula Kern Inrig
Assignee: Akebia Therapeutics Inc
Application Number:US15/563,169
Patent Claims: 1. A tablet formulation comprising an intra-granular component, an extra-granular component, and a film coating component, wherein the intra-granular component comprises about 60% to about 70% by weight of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, or a pharmaceutically acceptable salt thereof, about 20% to about 30% by weight of microcrystalline cellulose, about 2.5% to about 3.5% by weight of sodium starch glycolate, and about 2.3% to about 3.3% by weight of a hydroxypropyl methylcellulose; wherein the extra-granular component comprises about 2.5% to about 3.5% by weight of a sodium starch glycolate, about 0.2% to about 0.3% by weight of colloidal silicon dioxide, and about 0.55% to about 0.95% by weight of magnesium stearate; and wherein the film coating component comprises about 1.0% to about 8% by weight of a tablet coating.

2. The tablet formulation of claim 1, wherein the intra-granular component comprises about 65% by weight of Compound 1, about 25% by weight of microcrystalline cellulose, about 3% by weight of sodium starch glycolate, and about 2.8% by weight of a hydroxypropyl methylcellulose.

3. The tablet formulation of claim 1, comprising about 150 mg Compound 1.

4. The tablet formulation of claim 1, comprising about 300 mg Compound 1.

5. The tablet formulation of claim 1, comprising about 450 mg Compound 1.

6. The tablet formulation of claim 1, comprising about 600 mg Compound 1.

7. The tablet formulation of claim 1, wherein the intra-granular component comprises: about 150 mg Compound 1, about 57.46 mg microcrystalline cellulose, about 6.90 mg sodium starch glycolate, and about 6.44 mg hydroxypropyl methylcellulose; and wherein the total weight of the intra-granular and extra-granular components is about 230 mg.

8. The tablet formulation of claim 7, wherein the extra-granular component comprises: about 6.9 mg sodium starch glycolate, about 0.575 mg colloidal silicon dioxide, and about 1.725 mg magnesium stearate.

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