Phoslo

(Calcium acetate)

ApprovedSmall molecule

VVifor Fresenius Medical Care Renal Pharma

Phoslo is one of 43 small molecule programs targeting Endothelial Dysfunction. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Endothelial DysfunctionActive, not recruiting

CalcificationCompleted

Endothelial DysfunctionApproved

Active, not recruiting

CalcificationApproved

Completed

Competition

Competitive Landscape

39 competitors in Endothelial Dysfunction

#DrugCompanyPhaseTrials

Avapro

Sanofi

Approved

2 2

Plavix

Sanofi

Approved

2 3

Onglyza

AstraZeneca

Approved

1 4

Brilinta

AstraZeneca

Approved

1 5

Zyloprim

Jazz Pharmaceuticals

Approved

1 6

Ozempic

Novo Nordisk

Approved

1 7

Crestor

AstraZeneca

Approved

1 8

Prevacid

Andriol

2 10

Jardiance

Boehringer Ingelheim

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Chronic Kidney Disease3 trials

Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

Terminated·—·Phase 4·NCT01277497·30 enrolled

A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia

Terminated·VVifor Fresenius Medical Care Renal Pharma·Phase 3·NCT02688764·85 enrolled

EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)

Completed·NNabi Biopharmaceuticals·Phase 3·NCT00211978·110 enrolled

Calcification2 trials

Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate

Withdrawn·RRomanian Society of Nephrology·N/A·NCT00364000

CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients

Completed·NNabi Biopharmaceuticals·Phase 4·NCT00211939·203 enrolled

Endothelial Dysfunction1 trial

Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)

Completed·GGulhane School of Medicine·Phase 4·NCT01135615·100 enrolled

Thyroid1 trial

Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00018135

Peritoneal Dialysis1 trial

Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00196755·138 enrolled

6 more indications

Dialysis Patients1 trial

Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

Completed·FFresenius Medical Care North America·Phase 4·NCT01427907·38 enrolled

Excretion1 trial

Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus Excretion.

Completed·MMedical Research Council·Phase 1·NCT01991574·30 enrolled

Adult Subject1 trial

Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat

Completed·AAkebia Therapeutics·Phase 1·NCT04299633·54 enrolled

Randomized1 trial

A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD

Completed·DDenver Nephrologists, P.C.·N/A·NCT00785629·148 enrolled

Smallpox1 trial

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

Completed·SSIGA Technologies·Approved·NCT04485039·44 enrolled

Vascular1 trial

The Short-chain Fatty Acid Acetate for Improving Age-associated Arterial Dysfunction

Completed·UUniversity of Colorado, Denver·Phase 2·NCT05424263·37 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 10, 1990

PHOSLO

NDA NDA019976

Apr 2, 2001

PHOSLO

NDA NDA021160

Apr 18, 2011

PHOSLYRA

NDA NDA022581

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Calcium acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Calcium acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Calcium acetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022581). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Phoslo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Vifor Fresenius Medical Care Renal Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: VVifor Fresenius Medical Care Renal Pharma

Patent Landscape[5]

Patent Cliff

Jul 20, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8592480Jul 20, 2027

9089528Jul 20, 2027

8591938Feb 23, 2030

Phoslo

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Kidney Disease3 trials

Calcification2 trials

Endothelial Dysfunction1 trial

Thyroid1 trial

Peritoneal Dialysis1 trial

Dialysis Patients1 trial

Excretion1 trial

Adult Subject1 trial

Randomized1 trial

Smallpox1 trial

Vascular1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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