iloprost liposomal (L608) / Pharmosa Biopharm - LARVOL DELTA

Human Pharmacokinetics of Inhaled Liposomal Iloprost Support a Dosing Regimen for Treating Systemic Sclerosis- Related Digital Ulcer (ACR Convergence 2025) - P1 | "Inhaled liposomal iloprost is an extended-release formulation [2] which prolongs iloprost exposure in healthy subjects as demonstrated in phase 1 clinical trial. The results support a 28-day dosing regimen for self-administration in treating patients with systemic sclerosis-related digital ulcer."

PK/PD data • Immunology • Scleroderma • Systemic Sclerosis

Tolerability and pharmacokinetics of inhaled liposomal iloprost in healthy adults show its potential of treating CTEPH (ERS 2025) - P1 | "Inhaled liposomal iloprost was tolerated by healthy adults, indicating its potential of treating CTEPH with convenient administration."

Clinical • PK/PD data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Human Pharmacokinetics of Inhaled Liposomal Iloprost Indicates the Potential of Treating Systemic Sclerosis-Related Raynaud's Phenomenon and Digital Ulcer (EULAR 2025) - P1 | "Inhaled liposomal iloprost demonstrates extended-release formulation, supporting its potential for self-administration at home as a systemic therapy alternative to IV iloprost. These findings on human pharmacokinetics and tolerability highlight its promise in treating systemic sclerosis-related Raynaud’s phenomenon and digital ulcer."

PK/PD data • Cardiovascular • Immunology • Rheumatology • Scleroderma • Systemic Sclerosis

Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Pharmosa Biopharm Inc. | Recruiting ➔ Completed | Trial primary completion date: May 2024 ➔ Sep 2024

Trial completion • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

EXTENDED RELEASE OF INHALED ILOPROST LIPOSOME (L608) FOR TREATMENT OF SYSTEMIC SCLEROSIS-RELATED RAYNAUD PHENOMENA AND DIGITAL ULCER (EULAR 2024) - " The liposomal iloprost solution (L608) was prepared and characterized in terms of assay and encapsulation efficiency. Based on the rat PK data of sustained-release L608, the convenient dosage regimen with two to three inhalations per day is simulated to achieve the required plasma level for 6 hours a day, implying the potential to patient care."

Immunology • Scleroderma • Systemic Sclerosis

Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Pharmosa Biopharm Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases