Last reviewed 2026-05-14 · How we verify

Enteric coated sevelamer

Genzyme, a Sanofi Company · Phase 2 active Small molecule

Enteric coated sevelamer is a Phosphate-binding agent Small molecule drug developed by Genzyme, a Sanofi Company. It is currently in Phase 2 development for Chronic kidney disease, Hyperphosphatemia. Also known as: ECS.

Sevelamer binds to phosphate ions in the gastrointestinal tract, reducing phosphate absorption.

Sevelamer binds to phosphate ions in the gastrointestinal tract, reducing phosphate absorption. Used for Chronic kidney disease, Hyperphosphatemia.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Enteric coated sevelamer
Also known as	ECS
Sponsor	Genzyme, a Sanofi Company
Drug class	Phosphate-binding agent
Modality	Small molecule
Therapeutic area	Nephrology
Phase	Phase 2

Mechanism of action

Sevelamer is a phosphate-binding medication that works by forming an insoluble complex with phosphate ions in the gastrointestinal tract, thereby reducing phosphate absorption and lowering serum phosphate levels.

Approved indications

Chronic kidney disease
Hyperphosphatemia

Common side effects

Nausea
Vomiting
Diarrhea
Abdominal pain

Key clinical trials

A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia (PHASE2)

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:

Enteric coated sevelamer CI brief — competitive landscape report
Enteric coated sevelamer updates RSS · CI watch RSS
Genzyme, a Sanofi Company portfolio CI

Frequently asked questions about Enteric coated sevelamer

What is Enteric coated sevelamer?

Enteric coated sevelamer is a Phosphate-binding agent drug developed by Genzyme, a Sanofi Company, indicated for Chronic kidney disease, Hyperphosphatemia.

How does Enteric coated sevelamer work?

Sevelamer binds to phosphate ions in the gastrointestinal tract, reducing phosphate absorption.

What is Enteric coated sevelamer used for?

Enteric coated sevelamer is indicated for Chronic kidney disease, Hyperphosphatemia.

Who makes Enteric coated sevelamer?

Enteric coated sevelamer is developed by Genzyme, a Sanofi Company (see full Genzyme, a Sanofi Company pipeline at /company/genzyme-a-sanofi-company).

Is Enteric coated sevelamer also known as anything else?

Enteric coated sevelamer is also known as ECS.

What drug class is Enteric coated sevelamer in?

Enteric coated sevelamer belongs to the Phosphate-binding agent class. See all Phosphate-binding agent drugs at /class/phosphate-binding-agent.

What development phase is Enteric coated sevelamer in?

Enteric coated sevelamer is in Phase 2.

What are the side effects of Enteric coated sevelamer?

Common side effects of Enteric coated sevelamer include Nausea, Vomiting, Diarrhea, Abdominal pain.

Drug class: All Phosphate-binding agent drugs
Manufacturer: Genzyme, a Sanofi Company — full pipeline
Therapeutic area: All drugs in Nephrology
Indication: Drugs for Chronic kidney disease
Indication: Drugs for Hyperphosphatemia
Also known as: ECS

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing