Drugs / SP5M001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06307847 | Apr 2021 → Oct 2022 | osteoarthritis, hand | Shin Poong Pharmaceutical Co. Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-10-13 | Shin Poong Pharmaceutical Co. Ltd. | Results 신풍제약, 골관절염치료제 ‘하이알플렉스주’ 임상 3상 성공 shinpoong.co.kr ↗
두 군간 변화량의 차이는 미리 설정된 비열등성 한계 기준치 (-10mm) 보다 큰 -2.26mm(95% 신뢰구간 -7.34, 2.83) 로 , 투여군 ( 하이알플렉스주 ) 가 활성대조군 ( 시노비안주 ) 대비 비열등성을 입증했다 . |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-10-13 | Shin Poong Pharmaceutical Co. Ltd. | 신풍제약, 골관절염치료제 ‘하이알플렉스주’ 임상 3상 성공 shinpoong.co.kr ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SP5M001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06307847 ↗ |
| Modality | Other / unclassified | “novel hyaluronic acid hydrogel” PMID 40566128 ↗ Jun 2025 |
| Route | Other | “intra-articular injections” PMID 40566128 ↗ Jun 2025 |