Last reviewed 2026-06-02 · How we verify

Beta Glucosylceramide

Hadassah Medical Organization · Phase 1 active Small molecule ✓ Verified Jun 2026

Beta Glucosylceramide is a Small molecule drug developed by Hadassah Medical Organization. It is currently in Phase 1 development.

Beta Glucosylceramide is a substance studied in relation to Gaucher Disease, specifically in clinical trials involving treatments such as Eliglustat tartrate. It is also associated with conditions like Gaucher Disease and Healthy subjects, but its exact mechanism is not specified in the provided information.

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	Beta Glucosylceramide
Sponsor	Hadassah Medical Organization
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Beta Glucosylceramide CI brief — competitive landscape report
Beta Glucosylceramide updates RSS · CI watch RSS
Hadassah Medical Organization portfolio CI

Frequently asked questions about Beta Glucosylceramide

What is Beta Glucosylceramide?

Beta Glucosylceramide is a Small molecule drug developed by Hadassah Medical Organization.

Who makes Beta Glucosylceramide?

Beta Glucosylceramide is developed by Hadassah Medical Organization (see full Hadassah Medical Organization pipeline at /company/hadassah-medical-organization).

What development phase is Beta Glucosylceramide in?

Beta Glucosylceramide is in Phase 1.

Manufacturer: Hadassah Medical Organization — full pipeline

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