Last reviewed · How we verify
ALLO-ASC-DFU
ALLO-ASC-DFU is a Allogeneic mesenchymal stem cell therapy Biologic drug developed by Anterogen Co., Ltd.. It is currently in Phase 3 development for Diabetic foot ulcers (DFU). Also known as: Allogeneic mesenchymal stem cells, Allogenic adipose-derived mesenchymal stem cells, Hydrogel sheet containing allogenic mesenchymal stem cells, Hydrogel sheet containing Allogenic Mesenchymal Stem Cells.
ALLO-ASC-DFU is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes wound healing and tissue regeneration in diabetic foot ulcers.
ALLO-ASC-DFU is a small molecule being studied in a Phase 2 clinical trial for its efficacy and safety in treating Diabetic Foot Ulcer and Dystrophic Epidermolysis Bullosa. The trial is comparing ALLO-ASC-DFU to standard therapy and a vehicle sheet.
-
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).
| 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 name | ALLO-ASC-DFU |
|---|---|
| Also known as | Allogeneic mesenchymal stem cells, Allogenic adipose-derived mesenchymal stem cells, Hydrogel sheet containing allogenic mesenchymal stem cells, Hydrogel sheet containing Allogenic Mesenchymal Stem Cells |
| Sponsor | Anterogen Co., Ltd. |
| Drug class | Allogeneic mesenchymal stem cell therapy |
| Modality | Biologic |
| Therapeutic area | Dermatology / Wound Care |
| Phase | Phase 3 |
Mechanism of action
The drug consists of allogeneic (donor-derived) adipose-derived stem cells that are administered to diabetic foot ulcer sites to stimulate angiogenesis, reduce inflammation, and promote tissue repair and re-epithelialization. These mesenchymal stem cells secrete paracrine factors and growth factors that enhance the wound healing microenvironment and restore tissue integrity in chronic, non-healing diabetic ulcers.
Approved indications
- Diabetic foot ulcers (DFU)
Common side effects
- Injection site reactions
- Infection
- Pain at injection site
Key clinical trials
- Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers. (PHASE3)
- Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers (PHASE2)
- A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
- A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
- Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers. (PHASE3)
- A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial
- A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects (PHASE2)
- Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa (PHASE1, 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:
- ALLO-ASC-DFU CI brief — competitive landscape report
- ALLO-ASC-DFU updates RSS · CI watch RSS
- Anterogen Co., Ltd. portfolio CI
Frequently asked questions about ALLO-ASC-DFU
What is ALLO-ASC-DFU?
How does ALLO-ASC-DFU work?
What is ALLO-ASC-DFU used for?
Who makes ALLO-ASC-DFU?
Is ALLO-ASC-DFU also known as anything else?
What drug class is ALLO-ASC-DFU in?
What development phase is ALLO-ASC-DFU in?
What are the side effects of ALLO-ASC-DFU?
Related
- Drug class: All Allogeneic mesenchymal stem cell therapy drugs
- Manufacturer: Anterogen Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Dermatology / Wound Care
- Indication: Drugs for Diabetic foot ulcers (DFU)
- Also known as: Allogeneic mesenchymal stem cells, Allogenic adipose-derived mesenchymal stem cells, Hydrogel sheet containing allogenic mesenchymal stem cells, Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing