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Trehalose for IV Infusion
Trehalose for IV Infusion is a Small molecule drug developed by Bioblast Pharma Ltd.. It is currently in Phase 1 development.
Trehalose for IV infusion is an oligosaccharide used in clinical trials for various conditions, including Muscular Dystrophy, Oculopharyngeal (OPMD), Alzheimer's Disease, and pediatric brain tumors such as medulloblastoma and ependymoma. The exact mechanism of action of trehalose for IV infusion is not specified, but it is known to be an oligosaccharide, a type of sugar molecule.
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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 | Trehalose for IV Infusion |
|---|---|
| Sponsor | Bioblast Pharma Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- 131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (PHASE2)
- First-in-Human Study Testing a New Antibody Treatment for Tick-Borne Encephalitis in Healthy Volunteers. (PHASE1)
- STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia (PHASE2, PHASE3)
- SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease (PHASE2)
- Treatment of Oculopharyngeal Muscular Dystrophy With Trehalose (PHASE2)
- Continuation Protocol to Protocol BBCO-001 (PHASE3)
- A Study to Establish Safety and Maximum Tolerated Dose of IV Trehalose in Healthy Subjects (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:
- Trehalose for IV Infusion CI brief — competitive landscape report
- Trehalose for IV Infusion updates RSS · CI watch RSS
- Bioblast Pharma Ltd. portfolio CI
Frequently asked questions about Trehalose for IV Infusion
What is Trehalose for IV Infusion?
Who makes Trehalose for IV Infusion?
What development phase is Trehalose for IV Infusion in?
Related
- Manufacturer: Bioblast Pharma Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing