redasemtide (S-005151) / Shionogi, StemRIM - LARVOL DELTA

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=680 | Completed | Sponsor: Shionogi | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

Safety and efficacy profile of S-005151 (Redasemtide), in patients with chronic liver diseases: phase 2 trial. (PubMed, Inflamm Regen) - "S-005151 is well-tolerated in patients with chronic liver disease and may have therapeutic effects, in reducing liver damage and improving liver fibrosis."

Journal • P2 data • Dysphonia • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • Metabolic Dysfunction-Associated Steatohepatitis • HMGB1

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=680 | Active, not recruiting | Sponsor: Shionogi | Trial completion date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Mar 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=680 | Active, not recruiting | Sponsor: Shionogi | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Ischemic stroke

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=849 | Recruiting | Sponsor: Shionogi | N=627 ➔ 849

Enrollment change • Cardiovascular • Ischemic stroke

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=627 | Recruiting | Sponsor: Shionogi | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Notice of patent registration (China) for regeneration-inducing medicine redasemtide (HMGB1 fragment peptide) for the treatment of traumatic articular cartilage defects, osteoarthritis, and osteochondritis dissecans [Google translation] (StemRIM Press Release) - "We are pleased to announce that a patent has been registered in China for the use of a peptide drug (development code: S005151) created from regeneration-inducing medicine development candidate redasemtide (HMGB11), which we have licensed out to Shionogi & Co., Ltd...for a new treatment for traumatic articular cartilage defect, osteoarthritis, and osteochondritis dissecans....The purpose of this patent is to expand the indications of redasemtide, which is currently under development, and we believe that the establishment of this patent will ensure the possibility of developing therapeutic drugs based on redasemtide for traumatic articular cartilage defects, osteoarthritis, and osteochondritis dissecans in China."

Patent • Osteoarthritis

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=627 | Recruiting | Sponsor: Shionogi | Phase classification: P2b ➔ P2

Phase classification • Cardiovascular • Ischemic stroke

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2b | N=627 | Recruiting | Sponsor: Shionogi | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

REvive: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2b | N=627 | Not yet recruiting | Sponsor: Shionogi

New P2b trial • Cardiovascular • Ischemic stroke