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Calcium acetate (PhosLo® )
Calcium acetate (PhosLo® ) is a Phosphate binder Small molecule drug developed by Genzyme, a Sanofi Company. It is currently in Phase 3 development for Hyperphosphatemia in patients with end-stage renal disease on hemodialysis or peritoneal dialysis.
Calcium acetate binds to dietary phosphate in the gastrointestinal tract to reduce serum phosphate levels in patients with hyperphosphatemia.
Calcium acetate (PhosLo) is a small molecule that acts as a phosphate sequestering agent, binding to phosphate ions. It is used to treat conditions such as hyperphosphatemia, calcinosis, arteriosclerosis, and hyperparathyroidism, particularly in patients undergoing dialysis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Genzyme, a Sanofi Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Calcium acetate (PhosLo® ) |
|---|---|
| Sponsor | Genzyme, a Sanofi Company |
| Drug class | Phosphate binder |
| Target | Dietary phosphate (non-receptor mechanism) |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 3 |
Mechanism of action
Calcium acetate acts as a phosphate binder by forming insoluble calcium phosphate complexes in the intestinal lumen, which are then excreted in feces. This reduces the absorption of dietary phosphate and lowers serum phosphate concentrations. It is primarily used in patients with chronic kidney disease on dialysis who have elevated serum phosphate levels.
Approved indications
- Hyperphosphatemia in patients with end-stage renal disease on hemodialysis or peritoneal dialysis
Common side effects
- Hypercalcemia
- Gastrointestinal upset (nausea, constipation)
- Headache
Key clinical trials
- Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat (PHASE1)
- Occlusion vs Standard Treatment for the Treatment of Herpes Zoster (NA)
- 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 (PHASE3)
- Optimal Anemia Treatment in End Stage Renal Disease (ERSD) (NA)
- Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis (PHASE3)
- CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Calcium acetate (PhosLo® ) CI brief — competitive landscape report
- Calcium acetate (PhosLo® ) updates RSS · CI watch RSS
- Genzyme, a Sanofi Company portfolio CI
Frequently asked questions about Calcium acetate (PhosLo® )
What is Calcium acetate (PhosLo® )?
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What is Calcium acetate (PhosLo® ) used for?
Who makes Calcium acetate (PhosLo® )?
What drug class is Calcium acetate (PhosLo® ) in?
What development phase is Calcium acetate (PhosLo® ) in?
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What does Calcium acetate (PhosLo® ) target?
Related
- Drug class: All Phosphate binder drugs
- Target: All drugs targeting Dietary phosphate (non-receptor mechanism)
- Manufacturer: Genzyme, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Hyperphosphatemia in patients with end-stage renal disease on hemodialysis or peritoneal dialysis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing