Compositions and methods for treating anemia
Inventors
Shalwitz, Robert • Hartman, Charlotte • Buch, Akshay • Shalwitz, Isaiah • Janusz, John • Gardner, Joseph
Assignees
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Publication Number
US-12569474-B2
Publication Date
2026-03-10
Expiration Date
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 associated with or resulting from chemotherapy, or anemia associated with AIDS.
Core Innovation
The disclosure describes treating anemia secondary to or associated with chronic kidney disease by orally administering {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid (Compound 1), a HIF prolyl hydroxylase inhibitor, or a pharmaceutically acceptable salt thereof, once daily. Administered doses include [procedural detail omitted for safety]. Described patient groups include pre-dialysis and dialysis patients, as well as patients with stage 3, 4, or 5 chronic kidney disease.
The stated objective is to raise hemoglobin while mimicking diurnal erythropoietin variation, avoiding sustained erythropoietin elevation, and allowing levels to return toward baseline before the next dose. Clinical study reports indicate dose-related hemoglobin increases alongside changes consistent with enhanced iron mobilization, including increased total iron-binding capacity. The background section is not included in the supplied content, so the problem statement is not explicitly described in patent.
Claims Coverage
The supplied claims identify one independent claim with two inventive features covering the treatment of anemia associated with chronic kidney disease.
Oral administration of Compound 1 for chronic kidney disease anemia
A method for treating anemia secondary to or associated with chronic kidney disease by orally administering Compound 1, or a pharmaceutically acceptable salt thereof, once daily to a patient having the anemia, with dose amounts [procedural detail omitted for safety].
Chronic kidney disease patient subgroups
The method wherein the patient subgroups comprise pre-dialysis patients, dialysis patients, and patients with stage 3, 4, or 5 chronic kidney disease.
The claim coverage centers on oral, once-daily administration of Compound 1, or a pharmaceutically acceptable salt thereof, to treat anemia associated with chronic kidney disease across specified patient subgroups.
Stated Advantages
The treatment raises hemoglobin while aiming to preserve diurnal erythropoietin variation, avoid sustained erythropoietin elevation, and allow erythropoietin levels to return toward baseline.
The description reports dose-related hemoglobin increases in Phase 2a clinical studies.
The treatment provides changes consistent with enhanced iron mobilization, including increased total iron-binding capacity.
The text describes reduced cardiovascular and thromboembolic risks relative to exogenous erythropoietin as a proposed advantage.
Documented Applications
Treatment of anemia secondary to or associated with chronic kidney disease, including in pre-dialysis patients, dialysis patients, and patients with stage 3, 4, or 5 chronic kidney disease.
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