drugset
Drugs / SB-01
last change May 2026 re-read 3 minutes ago

SB-01

Developed for
lumbar disk degenerative disorder
Investigated by
MCRA · Spine BioPharma, Inc

Trials 1

today NCT05516992 · Ph 3
2023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT05516992 Aug 2022 → Mar 2025 overdue lumbar disk degenerative disorder Spine BioPharma, Inc Active not recruiting Missed primary

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-08-03 Ensol Bioscience Results [기사] 엔솔바이오, 디스크치료제 3상 "위약효과로 1차지표 미충족" ensolbio.com ↗
엔솔바이오사이언스의 퇴행성 디스크 질환 치료제(P2K/SB-01)의 임상 3상 톱라인 결과가 발표됐다.
2022-05-13 Ensol Bioscience Regulatory [기사]스파인바이오파마, 미국 임상 3상 개시 ensolbio.com ↗
Spine BioPharma, Inc., a company committed to developing non-opiate, non-surgical therapies for the treatment of chronic low back pain (CLBP) caused by degenerative disc disease (DDD), today announced the receipt of a U.S. Food and Drug Administration (FDA) Study May Proceed Letter authorizing the Company to proceed with a Phase 3 clinical study of SB-01 For Injection (SB-01).
2022-04-11 Ensol Bioscience Regulatory [기사]엔솔바이오사이언스 P2K 美 임상 3상 승인..‘코스닥 상장 청신호’ ensolbio.com ↗
유한양행과 엔솔바이오사이언스는 2018년 미국 스파인바이오파마로 기술이전된 퇴행성디스크 치료제 ‘YH14618’(SB-01, 레메디스크, 브니엘 2000)의 미국 임상 3상 시험계획이 승인됐다고 11일 밝혔다.

All press releases naming this drug 6 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as SB-01 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05516992 ↗
Route Other “Intradiscal injection” NCT05516992 ↗