Last reviewed 2026-05-22 · How we verify

Zymosan

George T. Budd · Phase 1 active Biologic ✓ Verified May 2026

Zymosan is a Biologic drug developed by George T. Budd. It is currently in Phase 1 development.

Zymosan is a beta-glucan found on the surface of fungi, such as yeast, with repeating glucose units connected by β-1,3-glycosidic linkages. It binds to TLR 2 and Dectin-1 (CLEC7A), and is being studied as a potential intervention in clinical trials for conditions such as triple-negative breast cancer.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Zymosan
Sponsor	George T. Budd
Modality	Biologic
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (EARLY_PHASE1)

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:

Zymosan CI brief — competitive landscape report
Zymosan updates RSS · CI watch RSS
George T. Budd portfolio CI

Frequently asked questions about Zymosan

What is Zymosan?

Zymosan is a Biologic drug developed by George T. Budd.

Who makes Zymosan?

Zymosan is developed by George T. Budd (see full George T. Budd pipeline at /company/george-t-budd).

What development phase is Zymosan in?

Zymosan is in Phase 1.

Manufacturer: George T. Budd — full pipeline
Therapeutic area: All drugs in Other

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