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Invossa K Inj.
Invossa K Inj. is a Gene therapy (cell-based) Biologic drug developed by Kolon Life Science. It is currently in Phase 3 development for Osteoarthritis of the knee (Phase 3).
Invossa K is a gene therapy that delivers TGF-β1 to stimulate cartilage regeneration and reduce joint degeneration in osteoarthritis.
Invossa K Inj. is a protein-based treatment used to study the safety and effectiveness in patients with osteoarthritis. It is being evaluated in a post-marketing surveillance study, NCT03412864, conducted by Kolon Life Science.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Invossa K Inj. |
|---|---|
| Sponsor | Kolon Life Science |
| Drug class | Gene therapy (cell-based) |
| Target | TGF-β1 (transforming growth factor-beta 1) |
| Modality | Biologic |
| Therapeutic area | Orthopedics / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Invossa K uses an allogeneic human chondrocyte cell line transduced with a retroviral vector carrying the TGF-β1 gene. When injected into the knee joint, these modified cells produce TGF-β1 locally, which promotes cartilage matrix synthesis and reduces inflammatory responses, thereby slowing or reversing osteoarthritic damage.
Approved indications
- Osteoarthritis of the knee (Phase 3)
Common side effects
- Joint pain or swelling
- Injection site reactions
- Transient fever or systemic inflammation
Key clinical trials
- A Post Marketing Surveillance Study of INVOSSA K Inj.
- The Efficacy and Safety of Invossa K Injection in Patients Diagnosed With Knee Osteoarthritis (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:
- Invossa K Inj. CI brief — competitive landscape report
- Invossa K Inj. updates RSS · CI watch RSS
- Kolon Life Science portfolio CI
Frequently asked questions about Invossa K Inj.
What is Invossa K Inj.?
How does Invossa K Inj. work?
What is Invossa K Inj. used for?
Who makes Invossa K Inj.?
What drug class is Invossa K Inj. in?
What development phase is Invossa K Inj. in?
What are the side effects of Invossa K Inj.?
What does Invossa K Inj. target?
Related
- Drug class: All Gene therapy (cell-based) drugs
- Target: All drugs targeting TGF-β1 (transforming growth factor-beta 1)
- Manufacturer: Kolon Life Science — full pipeline
- Therapeutic area: All drugs in Orthopedics / Rheumatology
- Indication: Drugs for Osteoarthritis of the knee (Phase 3)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing