Last reviewed 2026-04-23 · How we verify

NOVOCART® 3D plus

Tetec AG · Phase 3 active Small molecule

NOVOCART® 3D plus is a Autologous cell therapy Small molecule drug developed by Tetec AG. It is currently in Phase 3 development for Symptomatic cartilage defects of the knee, Osteoarthritis of the knee. Also known as: Matrix-associated autologous chondrocyte implantation.

NOVOCART® 3D plus is an autologous chondrocyte implant that regenerates cartilage tissue by delivering the patient's own expanded cartilage cells into a defect site.

NOVOCART® 3D plus is an autologous chondrocyte implant that regenerates cartilage tissue by delivering the patient's own expanded cartilage cells into a defect site. Used for Symptomatic cartilage defects of the knee, Osteoarthritis of the knee.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 plus
Also known as	Matrix-associated autologous chondrocyte implantation
Sponsor	Tetec AG
Drug class	Autologous cell therapy
Modality	Small molecule
Therapeutic area	Orthopedics / Regenerative Medicine
Phase	Phase 3

Mechanism of action

The product involves harvesting cartilage cells from the patient, expanding them in vitro, and implanting them back into the cartilage defect within a 3D collagen-based scaffold. This approach aims to restore functional cartilage tissue and reduce pain and dysfunction in osteoarthritis or cartilage injury. The 3D scaffold provides structural support and guides tissue regeneration.

Approved indications

Symptomatic cartilage defects of the knee
Osteoarthritis of the knee

Common side effects

Graft failure or poor integration
Joint swelling
Pain at implant site
Infection

Key clinical trials

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 plus CI brief — competitive landscape report
NOVOCART® 3D plus updates RSS · CI watch RSS
Tetec AG portfolio CI

Frequently asked questions about NOVOCART® 3D plus

What is NOVOCART® 3D plus?

NOVOCART® 3D plus is a Autologous cell therapy drug developed by Tetec AG, indicated for Symptomatic cartilage defects of the knee, Osteoarthritis of the knee.

How does NOVOCART® 3D plus work?

NOVOCART® 3D plus is an autologous chondrocyte implant that regenerates cartilage tissue by delivering the patient's own expanded cartilage cells into a defect site.

What is NOVOCART® 3D plus used for?

NOVOCART® 3D plus is indicated for Symptomatic cartilage defects of the knee, Osteoarthritis of the knee.

Who makes NOVOCART® 3D plus?

NOVOCART® 3D plus is developed by Tetec AG (see full Tetec AG pipeline at /company/tetec-ag).

Is NOVOCART® 3D plus also known as anything else?

NOVOCART® 3D plus is also known as Matrix-associated autologous chondrocyte implantation.

What drug class is NOVOCART® 3D plus in?

NOVOCART® 3D plus belongs to the Autologous cell therapy class. See all Autologous cell therapy drugs at /class/autologous-cell-therapy.

What development phase is NOVOCART® 3D plus in?

NOVOCART® 3D plus is in Phase 3.

What are the side effects of NOVOCART® 3D plus?

Common side effects of NOVOCART® 3D plus include Graft failure or poor integration, Joint swelling, Pain at implant site, Infection.

Drug class: All Autologous cell therapy drugs
Manufacturer: Tetec AG — full pipeline
Therapeutic area: All drugs in Orthopedics / Regenerative Medicine
Indication: Drugs for Symptomatic cartilage defects of the knee
Indication: Drugs for Osteoarthritis of the knee
Also known as: Matrix-associated autologous chondrocyte implantation

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