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durolane
durolane is a Small molecule drug developed by Assistance Publique Hopitaux De Marseille. It is currently in Phase 2 development.
Durolane is a non-animal stabilized hyaluronic acid (NASHA) used for intraarticular injections. It is indicated for the treatment of osteoarthritis in the knee, among other conditions, and is administered via injection into the joint.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | durolane |
|---|---|
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Intra-articular Corticosteroid With Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP) (NA)
- Knee OsteoArthritis Long-term Assessment (NA)
- Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis (PHASE2)
- Different Volumes of Durolane in Knee OA (PHASE2)
- Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis (NA)
- Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis (PHASE4)
- Durolane Versus Methylprednisolone in Knee Osteoarthritis (PHASE3)
- To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe (NA)
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:
- durolane CI brief — competitive landscape report
- durolane updates RSS · CI watch RSS
- Assistance Publique Hopitaux De Marseille portfolio CI
Frequently asked questions about durolane
What is durolane?
Who makes durolane?
What development phase is durolane in?
Related
- Manufacturer: Assistance Publique Hopitaux De Marseille — full pipeline
- Therapeutic area: All drugs in Urology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing