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co.don chondrosphere®
co.don chondrosphere® is a Cell-based therapy Small molecule drug developed by co.don AG. It is currently in Phase 3 development for Repair of cartilage defects in the knee. Also known as: ACT3D-CS.
co.don chondrosphere is a cell-based therapy that utilizes autologous chondrocytes to repair cartilage defects.
co.don chondrosphere is a cell-based therapy that utilizes autologous chondrocytes to repair cartilage defects. Used for Repair of cartilage defects in the knee.
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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 | co.don chondrosphere® |
|---|---|
| Also known as | ACT3D-CS |
| Sponsor | co.don AG |
| Drug class | Cell-based therapy |
| Modality | Small molecule |
| Therapeutic area | Orthopedics |
| Phase | Phase 3 |
Mechanism of action
The therapy involves the isolation of a patient's own chondrocytes, which are then expanded in vitro and seeded onto a scaffold. The resulting construct is implanted into the cartilage defect, where the chondrocytes promote the growth of new cartilage tissue.
Approved indications
- Repair of cartilage defects in the knee
Common side effects
- Pain
- Swelling
- Infection
Key clinical trials
- Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects (PHASE3)
- Assessment of Efficacy and Safety of 3 Different Doses of co.Don Chondrosphere to Treat Large Cartilage Defects (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:
- co.don chondrosphere® CI brief — competitive landscape report
- co.don chondrosphere® updates RSS · CI watch RSS
- co.don AG portfolio CI
Frequently asked questions about co.don chondrosphere®
What is co.don chondrosphere®?
How does co.don chondrosphere® work?
What is co.don chondrosphere® used for?
Who makes co.don chondrosphere®?
Is co.don chondrosphere® also known as anything else?
What drug class is co.don chondrosphere® in?
What development phase is co.don chondrosphere® in?
What are the side effects of co.don chondrosphere®?
Related
- Drug class: All Cell-based therapy drugs
- Manufacturer: co.don AG — full pipeline
- Therapeutic area: All drugs in Orthopedics
- Indication: Drugs for Repair of cartilage defects in the knee
- Also known as: ACT3D-CS
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing