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Hyalflex
- Development stage
- Phase 3
- Lead developer
- Shinpoong Pharma
- Modality
- Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Non-biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Implantable Hydrogels → Hydrogel Systems → Drug Delivery Systems
- Administration
- Intraarticular
01
Overview
Hyalflex (SP5M001) is a novel intra-articular injection containing hyaluronic acid cross-linked with hexamethylenediamine (HMDA), developed by Shin Poong Pharmaceutical for the treatment of mild-to-moderate knee osteoarthritis. As a viscosupplement, Hyalflex is designed to restore the rheological properties of synovial fluid, which are typically compromised in osteoarthritic joints. By providing lubrication and shock absorption, it helps to reduce weight-bearing pain and improve physical function. Unlike many conventional hyaluronic acid treatments that use 1,4-butanediol diglycidyl ether (BDDE) as a cross-linking agent, Hyalflex utilizes HMDA to create a stable hydrogel. Clinical Phase 3 data has demonstrated that Hyalflex is non-inferior in efficacy and safety to existing BDDE-cross-linked hyaluronic acid injections, such as Synovian.
- Brand names
- Hyalflex
- Other names
- hexamethylenediamine cross-linked hyaluronateHMDA-HASP5M001 Inj.SP-5M001 Inj.SP 5M001 Inj.
02
Targets
Hyaluronic acid polymer network in synovial fluid
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