Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis

Summary

This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.

Timeline

Start

2021-04-14

Primary completion

2022-10-25

Completion

2022-10-25

Outcome

Met primary endpoint

paper yielding a difference of 2.26 mm (95% confidence interval [CI]: -2.83 to 7.34; p = 0.3825), thus demonstrating the non-inferiority of HMDA-HA to BDDE-HA. PMID 40566128 ↗

release “신풍제약 , 골관절염치료제 ‘ 하이알플렉스주 ’ 임상 3 상 성공” shinpoong.co.kr ↗

release “이번 임상은 하이알플렉스주 (SP5M001 주 ) 의 유효성이 시노비안주 ( 성분명 BDDE 가교히알루론산나트륨겔 ) 대비 비열등함을 입증하고” shinpoong.co.kr ↗

Publications

• Kim KI, In Y, Choi HS, Lee JH, Sim JA, Lee HJ, Moon YW, Shon OJ, Seon JK, Kim YM, Song SJ, Chang CB, Han HS. A Multicentre, Double-Blind, Randomised, Non-Inferiority Trial of a Novel Single-Injection Intra-Articular HMDA-Cross-Linked Hyaluronate Gel for Knee Osteoarthritis. J Clin Med. 2025 Jun 19;14(12):4384. doi: 10.3390/jcm14124384.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SP5M001	Other / unclassified	5 ml	Other
Comparator	Synovian	Other / unclassified	3 ml	Other

Indications