LT3001 / Lumosa Therap, Shanghai Pharma - LARVOL DELTA

A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Lumosa Therapeutics Co., Ltd. | Unknown status ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Cardiovascular • Ischemic stroke

A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects (clinicaltrials.gov) - P1 | N=65 | Completed | Sponsor: Lumosa Therapeutics Co., Ltd. | Recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

Taiwan's Lumosa Therapeutics advances ischemic stroke drug with US FDA feedback (Taiwan News) - "Lumosa’s LT3001 is an innovative small-molecule drug that works in two ways: it helps dissolve blood clots and protects brain cells...The FDA guidance follows Lumosa’s earlier Type C consultation, which focused on preclinical data completeness, Phase III trial design, including efficacy endpoints, sample size, patient eligibility, and interim analyses, and other requirements for potential US regulatory approval. The company said the FDA’s recommendations will be used to finalize the Phase III clinical trial protocol..."

IND • New P3 trial • Ischemic stroke

BRIGHT: A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects (clinicaltrials.gov) - P2 | N=89 | Completed | Sponsor: Lumosa Therapeutics Co., Ltd. | Not yet recruiting ➔ Completed | N=200 ➔ 89 | Trial completion date: Mar 2024 ➔ May 2025 | Trial primary completion date: Mar 2024 ➔ May 2025

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

A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Lumosa Therapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2024 ➔ Mar 2026 | Trial primary completion date: Apr 2024 ➔ Mar 2026

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

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Dec 2025

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

EVALUATING THE SAFETY AND EFFICACY OF LT3001 IN ACUTE ISCHEMIC STROKE PATIENTS UNDERGOING EVT (ESOC 2024) - P2 | "The result would provide valuable insights into the safety and potential benefit of LT3001 for AIS patients, particularly those undergoing IA EVT."

Clinical • Cardiovascular • Ischemic stroke

LT3001, A NEW SYNTHETIC MOLECULE FOR STROKE TREATMENT, INCREASES FIBRINOLYSIS BY BRIDGING PLASMIN(OGEN) ONTO FIBRIN CLOT (ESOC 2023) - "LT3001 induced fibrinolysis by enhancing the bridging of plasmin(ogen) onto fibrin clot, instead of directly enhancing tPA activity. The results further support the phenomenon of less bleeding risk observed in the animal models and clinical trials."

Cardiovascular

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

New P2 trial • Cardiovascular • Ischemic stroke

BRIGHT: A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Lumosa Therapeutics Co., Ltd.

New P2 trial • Cardiovascular • Ischemic stroke