Last reviewed 2026-05-28 · How we verify

ALD-401

Aldagen · Phase 2 active Biologic Under review

ALD-401 is a Biologic drug developed by Aldagen. It is currently in Phase 2 development for Ischemic heart failure. Also known as: ALDHbr cells, ALDH Bright cells.

ALD-401 is a stem cell therapy that aims to promote tissue repair and regeneration.

ALD-401 is a treatment being studied for stroke, ischemic stroke, and stroke in the middle cerebral artery (MCA). It is administered via intracarotid infusion in a randomized, controlled study.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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 name	ALD-401
Also known as	ALDHbr cells, ALDH Bright cells
Sponsor	Aldagen
Modality	Biologic
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

ALD-401 is a type of cell therapy that utilizes a patient's own stem cells to stimulate the repair and regeneration of damaged tissues. This is achieved through the administration of a specific type of stem cell that has been shown to have regenerative properties.

Approved indications

Ischemic heart failure

Common side effects

Injection site reaction

Key clinical trials

Study of ALD-401 Via Intracarotid Infusion in Ischemic Stroke Subjects (PHASE2)

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:

ALD-401 CI brief — competitive landscape report
ALD-401 updates RSS · CI watch RSS
Aldagen portfolio CI

Frequently asked questions about ALD-401

What is ALD-401?

ALD-401 is a Biologic drug developed by Aldagen, indicated for Ischemic heart failure.

How does ALD-401 work?

ALD-401 is a stem cell therapy that aims to promote tissue repair and regeneration.

What is ALD-401 used for?

ALD-401 is indicated for Ischemic heart failure.

Who makes ALD-401?

ALD-401 is developed by Aldagen (see full Aldagen pipeline at /company/aldagen).

Is ALD-401 also known as anything else?

ALD-401 is also known as ALDHbr cells, ALDH Bright cells.

What development phase is ALD-401 in?

ALD-401 is in Phase 2.

What are the side effects of ALD-401?

Common side effects of ALD-401 include Injection site reaction.

Manufacturer: Aldagen — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Ischemic heart failure
Also known as: ALDHbr cells, ALDH Bright cells

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