Last reviewed · How we verify
NOVOCART 3D
NOVOCART 3D is a Cell and tissue therapy Biologic drug developed by Aesculap Biologics, LLC. It is currently in Phase 3 development for Articular cartilage defects of the knee.
NOVOCART 3D is an autologous engineered cartilage construct that regenerates damaged articular cartilage by combining patient's own cells with a 3D scaffold.
NOVOCART 3D is a small molecule used to treat cartilage diseases, including traumatic articular cartilage defects in the knee joint. It has been studied in clinical trials, including a Phase III study comparing its effectiveness to microfracture in treating knee cartilage defects.
-
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 | NOVOCART 3D |
|---|---|
| Sponsor | Aesculap Biologics, LLC |
| Drug class | Cell and tissue therapy |
| Modality | Biologic |
| Therapeutic area | Orthopedics / Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
The product uses a patient's own chondrocytes (cartilage cells) expanded ex vivo and seeded onto a 3D collagen-based scaffold to create a tissue-engineered cartilage graft. This construct is implanted into cartilage defects to restore joint surface integrity and function. The approach aims to promote natural cartilage regeneration and repair rather than symptomatic treatment.
Approved indications
- Articular cartilage defects of the knee
Common side effects
- Graft failure or poor integration
- Joint swelling
- Pain at implant site
- Infection
Key clinical trials
- Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
- NOVOCART 3D Treatment Following Microfracture Failure (PHASE3)
- NOVOCART®3D for Treatment of Articular Cartilage of the Knee (PHASE3)
- Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects (PHASE3)
- Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
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:
- NOVOCART 3D CI brief — competitive landscape report
- NOVOCART 3D updates RSS · CI watch RSS
- Aesculap Biologics, LLC portfolio CI
Frequently asked questions about NOVOCART 3D
What is NOVOCART 3D?
How does NOVOCART 3D work?
What is NOVOCART 3D used for?
Who makes NOVOCART 3D?
What drug class is NOVOCART 3D in?
What development phase is NOVOCART 3D in?
What are the side effects of NOVOCART 3D?
Related
- Drug class: All Cell and tissue therapy drugs
- Manufacturer: Aesculap Biologics, LLC — full pipeline
- Therapeutic area: All drugs in Orthopedics / Regenerative Medicine
- Indication: Drugs for Articular cartilage defects of the knee
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing