TheraRadar
Data updated: May 26, 2026

PHOSLYRA (calcium acetate)

Renal Approved 2011-04-18
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Discontinued
First Approved
2011-04-18
Patent Cliff
2030

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

Active Ingredient: CALCIUM ACETATE

PHOSLYRA Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2011 to 2020
Sep 2020 SUPPL
Label · Labeling
Apr 2015 SUPPL
Label · Labeling
Aug 2014 SUPPL
Mfg · Manufacturing (CMC)

What PHOSLYRA Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
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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.

PHOSLYRA FDA Label Details

View full patent landscape →
3 OB patents · 1 families · 38 international docs across 18 countries

PHOSLYRA Patents & Exclusivity

Latest Patent: Feb 2030

Patents (3 active)

US8591938 Expires Feb 23, 2030
US8592480 Expires Jul 20, 2027
US9089528 Expires Jul 20, 2027
Source: FDA Orange Book

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Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2030
  • 3 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • Competitor tracking
  • Same target/indication analysis
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Data Sources

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