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ASCs (Cx401, company code)
ASCs (Cx401, company code) is a Allogeneic mesenchymal stem cell therapy Small molecule drug developed by Tigenix S.A.U.. It is currently in Phase 3 development for Chronic diabetic foot ulcers.
Cx401 is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue repair and reduces inflammation in chronic wounds.
Cx401 is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue repair and reduces inflammation in chronic wounds. Used for Chronic diabetic foot ulcers.
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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 | ASCs (Cx401, company code) |
|---|---|
| Sponsor | Tigenix S.A.U. |
| Drug class | Allogeneic mesenchymal stem cell therapy |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Wound Care |
| Phase | Phase 3 |
Mechanism of action
Cx401 consists of expanded allogeneic adipose-derived stem cells (ASCs) that are applied topically to chronic diabetic foot ulcers. These cells are believed to work through paracrine signaling, secreting anti-inflammatory cytokines and growth factors that promote angiogenesis, reduce inflammation, and enhance wound healing. The mechanism leverages the immunomodulatory and regenerative properties of mesenchymal stem cells to improve tissue repair in non-healing wounds.
Approved indications
- Chronic diabetic foot ulcers
Common side effects
- Application site reactions
- Infection
- Wound deterioration
Key clinical trials
- Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled Trial
- Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease (PHASE3)
- Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease (PHASE3)
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:
- ASCs (Cx401, company code) CI brief — competitive landscape report
- ASCs (Cx401, company code) updates RSS · CI watch RSS
- Tigenix S.A.U. portfolio CI
Frequently asked questions about ASCs (Cx401, company code)
What is ASCs (Cx401, company code)?
How does ASCs (Cx401, company code) work?
What is ASCs (Cx401, company code) used for?
Who makes ASCs (Cx401, company code)?
What drug class is ASCs (Cx401, company code) in?
What development phase is ASCs (Cx401, company code) in?
What are the side effects of ASCs (Cx401, company code)?
Related
- Drug class: All Allogeneic mesenchymal stem cell therapy drugs
- Manufacturer: Tigenix S.A.U. — full pipeline
- Therapeutic area: All drugs in Dermatology / Wound Care
- Indication: Drugs for Chronic diabetic foot ulcers
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing