Last reviewed 2026-05-15 · How we verify

80 million hMSCs

National University of Ireland, Galway, Ireland · Phase 1 active Small molecule Quality 0/100

80 million hMSCs is a Small molecule drug developed by National University of Ireland, Galway, Ireland. It is currently in Phase 1 development. Also known as: 80 million hMSCs intramuscularly.

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	80 million hMSCs
Also known as	80 million hMSCs intramuscularly
Sponsor	National University of Ireland, Galway, Ireland
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:

80 million hMSCs CI brief — competitive landscape report
80 million hMSCs updates RSS · CI watch RSS
National University of Ireland, Galway, Ireland portfolio CI

Frequently asked questions about 80 million hMSCs

What is 80 million hMSCs?

80 million hMSCs is a Small molecule drug developed by National University of Ireland, Galway, Ireland.

Who makes 80 million hMSCs?

80 million hMSCs is developed by National University of Ireland, Galway, Ireland (see full National University of Ireland, Galway, Ireland pipeline at /company/national-university-of-ireland-galway-ireland).

Is 80 million hMSCs also known as anything else?

80 million hMSCs is also known as 80 million hMSCs intramuscularly.

What development phase is 80 million hMSCs in?

80 million hMSCs is in Phase 1.

Manufacturer: National University of Ireland, Galway, Ireland — full pipeline
Also known as: 80 million hMSCs intramuscularly

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