TR-012001 / Shin Nippon Biomedical Labs - LARVOL DELTA

A Phase I Study of TR-012001, a Nasal Levodopa, in Healthy Adult Japanese Male Subjects (MDS Congress 2025) - "TR-012001 was administered in a fasted state after the oral administration of carbidopa (CD; 50 mg/dose, 3 doses every 8 h). This study demonstrated the safety, tolerability, and rapid LD nasal absorption of TR-012001 in healthy subjects, which supports its further clinical development as a new ODT option for PD. This work was previously presented at the 66th Annual Meeting of the Japanese Society of Neurology (May 21–24, 2025)."

Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

A Proof-of-Concept Study of TR-012001, a Nasal Levodopa, in Patients With Parkinson's Disease With OFF Episodes, Without Dopa Decarboxylase Inhibitor (MDS Congress 2025) - "The study reports satisfactory safety and tolerability results for TR-012001 (total levodopa 40 mg). The rapid increase in plasma levodopa concentration and the motor improvement seen in patients with PD support its further clinical development to provide a new ODT option for PD. This work was previously presented at the 2025 Annual Meeting of the American Academy of Neurology (April 5–9, 2025) and the 66th Annual Meeting of the Japanese Society of Neurology (May 21–24, 2025)."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Results of an exploratory phase II clinical trial of levodopa nasal spray TR-012001 (JSNE 2025) - No abstract available

Clinical • P2 data • CNS Disorders • Gene Therapies • Movement Disorders • Parkinson's Disease

Results of a Phase I clinical trial of levodopa nasal spray (TR-012001) in healthy Japanese adult males (JSNE 2025) - No abstract available

Clinical • P1 data • CNS Disorders • Gene Therapies • Movement Disorders • Parkinson's Disease

A Proof-of-concept Study of TR-012001, a Nasal Levodopa, in Patients with Parkinson's Disease with OFF Episodes, Without Dopa Decarboxylase Inhibitor (AAN 2025) - "The study has provided satisfactory safety and tolerability results for TR-012001 (total levodopa 40 mg). The rapid increase in the plasma levodopa concentration and the motor improvement seen in patients with PD supports further clinical development to provide a new ODT option for PD."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase II Clinical Study of TR-012001 in Japanese Patients With Parkinson's Disease (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: SNLD, Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase II Clinical Study of TR-012001 in Japanese Patients With Parkinson's Disease (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: SNLD, Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease