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Synovian inj
Synovian inj is a Hyaluronic acid derivative; viscosupplement Small molecule drug developed by Shin Poong Pharmaceutical Co. Ltd.. It is currently in Phase 3 development for Osteoarthritis of the knee, Osteoarthritis of other joints (hip, shoulder, ankle).
Synovian is a hyaluronic acid-based intra-articular injection that lubricates and cushions joint cartilage to reduce pain and improve mobility in osteoarthritis.
Synovian is a hyaluronic acid-based intra-articular injection that lubricates and cushions joint cartilage to reduce pain and improve mobility in osteoarthritis. Used for Osteoarthritis of the knee, Osteoarthritis of other joints (hip, shoulder, ankle).
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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 | Synovian inj |
|---|---|
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. |
| Drug class | Hyaluronic acid derivative; viscosupplement |
| Target | Hyaluronic acid receptor (CD44); joint synovial fluid |
| Modality | Small molecule |
| Therapeutic area | Rheumatology; Orthopedics |
| Phase | Phase 3 |
Mechanism of action
Synovian works by supplementing the synovial fluid in affected joints with hyaluronic acid, a naturally occurring polysaccharide that provides viscosity and elasticity to joint fluid. This restores the lubricating and shock-absorbing properties of the joint, reducing friction between cartilage surfaces and alleviating pain associated with osteoarthritis. The treatment is administered directly into the joint space for localized therapeutic effect.
Approved indications
- Osteoarthritis of the knee
- Osteoarthritis of other joints (hip, shoulder, ankle)
Common side effects
- Injection site pain or swelling
- Transient joint effusion
- Local inflammation
- Allergic reaction
Key clinical trials
- Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis (PHASE3)
- Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis (PHASE3)
- Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee (PHASE3)
- Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee
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:
- Synovian inj CI brief — competitive landscape report
- Synovian inj updates RSS · CI watch RSS
- Shin Poong Pharmaceutical Co. Ltd. portfolio CI
Frequently asked questions about Synovian inj
What is Synovian inj?
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Related
- Drug class: All Hyaluronic acid derivative; viscosupplement drugs
- Target: All drugs targeting Hyaluronic acid receptor (CD44); joint synovial fluid
- Manufacturer: Shin Poong Pharmaceutical Co. Ltd. — full pipeline
- Therapeutic area: All drugs in Rheumatology; Orthopedics
- Indication: Drugs for Osteoarthritis of the knee
- Indication: Drugs for Osteoarthritis of other joints (hip, shoulder, ankle)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing