Last reviewed · How we verify

Maltobiose (MALTOSE)

Phase 3 active Oligosaccharide ✓ Verified May 2026

Maltobiose (generic name: MALTOSE) is a drug. It is currently in Phase 3 development.

Maltobiose works by interacting with specific biological pathways, although the exact mechanism is unknown.

Maltobiose is an oligosaccharide, a type of complex sugar molecule. It is also known by other names, including maltose, which is a synonym for maltobiose.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameMALTOSE
ModalityOligosaccharide
Therapeutic areaOther
PhasePhase 3

Mechanism of action

Imagine your body's cells are like locks, and maltobiose is a key that fits into those locks. When it binds to the locks, it can trigger a response that helps to treat certain conditions. However, the exact way it works is still a mystery and requires further research.

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Maltobiose

What is Maltobiose?

Maltobiose (MALTOSE) is a Oligosaccharide drug.

How does Maltobiose work?

Maltobiose works by interacting with specific biological pathways, although the exact mechanism is unknown.

What is the generic name of Maltobiose?

MALTOSE is the generic (nonproprietary) name of Maltobiose.

What development phase is Maltobiose in?

Maltobiose is in Phase 3.

What are the side effects of Maltobiose?

Common side effects of Maltobiose include Appendicolith, Blood phosphorus increased, Appendicitis, Ventricular fibrillation, Cardiogenic shock, Ascites.

Related

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