Last reviewed · How we verify
glucocerebrosidase
glucocerebrosidase is a Small molecule drug developed by National Center for Research Resources (NCRR). It is currently in Phase 2 development for Chronic non-neuropathic Gaucher's disease.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | glucocerebrosidase |
|---|---|
| Sponsor | National Center for Research Resources (NCRR) |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Approved indications
- Chronic non-neuropathic Gaucher's disease
Common side effects
- Nasopharyngitis
- Arthralgia
- Headache
- Upper respiratory tract infection
- Back pain
- Cough
- Fatigue
- Pharyngolaryngeal pain
- Pyrexia
- Influenza
- Myalgia
- Pain in extremity
Key clinical trials
- Genetic Studies of Lysosomal Storage Disorders
- Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease (NA)
- Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (PHASE1, PHASE2)
- Positron Emission Tomography (PET) Imaging in People With Gaucher Mutations
- MR-guided Focused Ultrasound Plus GCase (NA)
- Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3 (PHASE3)
- International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
- Genotypic Influences on Network Progression in Parkinson's Disease
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:
- glucocerebrosidase CI brief — competitive landscape report
- glucocerebrosidase updates RSS · CI watch RSS
- National Center for Research Resources (NCRR) portfolio CI
Frequently asked questions about glucocerebrosidase
What is glucocerebrosidase?
What is glucocerebrosidase used for?
Who makes glucocerebrosidase?
What development phase is glucocerebrosidase in?
What are the side effects of glucocerebrosidase?
Related
- Manufacturer: National Center for Research Resources (NCRR) — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Chronic non-neuropathic Gaucher's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing