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Allogeneic Mesenchymal Precursor Cells

Mesoblast, Ltd. · Phase 2 active Small molecule ✓ Verified May 2026 Quality 40/100

Allogeneic Mesenchymal Precursor Cells is a Cell therapy Small molecule drug developed by Mesoblast, Ltd.. It is currently in Phase 2 development.

Mesenchymal precursor cells modulate immune responses and reduce inflammation through paracrine signaling and cell-to-cell interactions.

Allogeneic Mesenchymal Precursor Cells are a type of somatic cell supplemental therapy used to treat various conditions, including Hypoplastic Left Heart Syndrome, Atrioventricular Canal, Rheumatoid Arthritis, Coronary Artery Disease, and Ischemic Cardiomyopathy. The exact mechanism of action of Allogeneic Mesenchymal Precursor Cells is currently unknown.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameAllogeneic Mesenchymal Precursor Cells
SponsorMesoblast, Ltd.
Drug classCell therapy
ModalitySmall molecule
PhasePhase 2

Mechanism of action

These cells secrete anti-inflammatory cytokines and growth factors that modulate immune cell function, reduce pro-inflammatory signaling, and promote tissue repair. They interact with immune cells to suppress excessive inflammatory responses without broadly suppressing the immune system.

Approved indications

Common side effects

No common side effects on file.

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 Allogeneic Mesenchymal Precursor Cells

What is Allogeneic Mesenchymal Precursor Cells?

Allogeneic Mesenchymal Precursor Cells is a Cell therapy drug developed by Mesoblast, Ltd..

How does Allogeneic Mesenchymal Precursor Cells work?

Mesenchymal precursor cells modulate immune responses and reduce inflammation through paracrine signaling and cell-to-cell interactions.

Who makes Allogeneic Mesenchymal Precursor Cells?

Allogeneic Mesenchymal Precursor Cells is developed by Mesoblast, Ltd. (see full Mesoblast, Ltd. pipeline at /company/mesoblast-ltd).

What drug class is Allogeneic Mesenchymal Precursor Cells in?

Allogeneic Mesenchymal Precursor Cells belongs to the Cell therapy class. See all Cell therapy drugs at /class/cell-therapy.

What development phase is Allogeneic Mesenchymal Precursor Cells in?

Allogeneic Mesenchymal Precursor Cells is in Phase 2.

Related

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