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Acetal resin
Acetal resin is a Ion-exchange resin Biologic drug developed by Al-Azhar University. It is currently in Phase 3 development. Also known as: PEEK.
Acetal resin is a synthetic polymer that functions as an ion-exchange resin to bind and remove target molecules from the gastrointestinal tract.
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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).
| 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 | Acetal resin |
|---|---|
| Also known as | PEEK |
| Sponsor | Al-Azhar University |
| Drug class | Ion-exchange resin |
| Modality | Biologic |
| Phase | Phase 3 |
Mechanism of action
Acetal resins are cross-linked polymeric materials designed to selectively bind specific ions or molecules in the GI tract, preventing their absorption or promoting their elimination. These resins work through ion-exchange mechanisms and are typically used to reduce circulating levels of target compounds by interrupting enterohepatic circulation or direct GI binding.
Approved indications
Common side effects
- Gastrointestinal effects (constipation, bloating, nausea)
- Reduced absorption of other medications
Key clinical trials
- Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth (PHASE3)
- A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars (PHASE3)
- Evaluation of Microbial Growth on Bre-Flex Versus PEEK Denture Base in Bilateral Maxillary Bounded Partial Denture (NA)
- Evaluation of Candida Albicans Growth on BreFlex Versus PEEK Denture Base in Maxillary Bounded Partial Denture (NA)
- Comparative Study of Biting Force of Injection Molded PEEK and Bre.Flex for Removable Partial Dentures. (NA)
- Retention of Peek and Bre.Flex Materials Maxillary Bilateral Bounded Removable Partial Dentures (NA)
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:
- Acetal resin CI brief — competitive landscape report
- Acetal resin updates RSS · CI watch RSS
- Al-Azhar University portfolio CI
Frequently asked questions about Acetal resin
What is Acetal resin?
How does Acetal resin work?
Who makes Acetal resin?
Is Acetal resin also known as anything else?
What drug class is Acetal resin in?
What development phase is Acetal resin in?
What are the side effects of Acetal resin?
Related
- Drug class: All Ion-exchange resin drugs
- Manufacturer: Al-Azhar University — full pipeline
- Also known as: PEEK
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing