TheraRadar
Data updated: May 26, 2026

CALCIUM ACETATE

Renal Approved 2008-01-30

Calcium acetate helps patients with end stage renal disease manage their phosphorus levels. It is used to lower high serum phosphorus concentrations that often occur when the kidneys are no longer functioning effectively. This medication acts as a phosphate binder to help maintain healthier mineral balances in the blood.

Source: FDA Label • SUVEN PHARMS

How CALCIUM ACETATE Works

This drug works by combining with phosphate found in food when taken during meals. This interaction creates an insoluble calcium phosphate complex that the body cannot absorb. The complex is then excreted through the feces, which effectively reduces the overall concentration of phosphorus in the blood.

Source: FDA Label
14
Indications
--
Phase 3 Trials
18
Years on Market

CALCIUM ACETATE Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2008 to 2026
May 2026 SUPPL
Label · Labeling
Mar 2023 ORIGINAL
Update
Nov 2020 SUPPL
Label · Labeling

What CALCIUM ACETATE Treats

2 indications

CALCIUM ACETATE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • End stage renal disease
  • High serum phosphorus
Source: FDA Label

CALCIUM ACETATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT04299633 AKB-6548-CI-0037 Ph 1 completed Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
NCT01277497 2902 Ph 4 terminated Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
NCT01135615 GATAFGF23Sevelamer Ph 4 completed Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CALCIUM ACETATE FDA Label Details

Indications & Usage

CALCIUM ACETATE is indicated for the treatment of End stage renal disease; High serum phosphorus.

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PHOSLYRA

Full clinical data, patents, trials, and competitive landscape for calcium acetate.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.