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sevelamer phosphate-binders
sevelamer phosphate-binders is a Small molecule drug developed by Azienda Sanitaria ASL Avellino 2. It is currently in Phase 1 development. Also known as: Renagel.
Sevelamer phosphate-binders are small molecule medications used to treat conditions such as Chronic Kidney Disease, Kidney Failure, and Hyperphosphatemia. They are indicated for patients undergoing hemodialysis, as demonstrated in a randomized, multi-center study comparing them to calcium acetate oral solution.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | sevelamer phosphate-binders |
|---|---|
| Also known as | Renagel |
| Sponsor | Azienda Sanitaria ASL Avellino 2 |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia (PHASE3)
- A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia (PHASE3)
- FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease (PHASE3)
- Activated Charcoal Use in Chronic Kidney Disease Patients (PHASE2)
- Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders (PHASE4)
- A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients (PHASE2)
- A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP (PHASE4)
- Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy (PHASE2, PHASE3)
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:
- sevelamer phosphate-binders CI brief — competitive landscape report
- sevelamer phosphate-binders updates RSS · CI watch RSS
- Azienda Sanitaria ASL Avellino 2 portfolio CI
Frequently asked questions about sevelamer phosphate-binders
What is sevelamer phosphate-binders?
Who makes sevelamer phosphate-binders?
Is sevelamer phosphate-binders also known as anything else?
What development phase is sevelamer phosphate-binders in?
Related
- Manufacturer: Azienda Sanitaria ASL Avellino 2 — full pipeline
- Also known as: Renagel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing