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oral β-glucan
oral β-glucan is a Biologic drug developed by Memorial Sloan Kettering Cancer Center. It is currently in Phase 1 development.
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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 | oral β-glucan |
|---|---|
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma (PHASE2)
- A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma (PHASE2)
- Dietary Fiber and Probiotics in Advanced Colorectal Cancer (NA)
- Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (PHASE1, PHASE2)
- Antioxidant and Immunomodulatory Effect of a β-glucan Fiber From Saccharomyces Cerevisiae (NA)
- Effect of Various Processed Oat Bran in a Beverage Matrix on Glycaemic Health (NA)
- Effect of Prebiotics on Blood Pressure Management (NA)
- Effect of Prebiotics on Blood Glucose Management (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:
- oral β-glucan CI brief — competitive landscape report
- oral β-glucan updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI
Frequently asked questions about oral β-glucan
What is oral β-glucan?
Who makes oral β-glucan?
What development phase is oral β-glucan in?
Related
- Manufacturer: Memorial Sloan Kettering Cancer Center — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing