ZMA001 / Zymedi - LARVOL DELTA

Electrochemiluminescence immunoassay for quantifying ZMA001 in human serum: method development, validation, and clinical pharmacokinetic application. (PubMed, Bioanalysis) - P1 | "Based on preliminary pharmacokinetic data, the average maximum concentration is 41.8 μg/mL while the half-life is about 9.9 days. The method provides a rapid and sensitive approach for the quantitative assessment of ZMA001 in human serum and is well-suited for use in ongoing and future clinical studies."

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

Study of Intravenous ZMA001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Suspended ➔ Recruiting | N=20 ➔ 96 | Trial completion date: Aug 2027 ➔ Nov 2027 | Trial primary completion date: Apr 2026 ➔ Sep 2027

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

Study of Intravenous ZMA001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Suspended | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Sep 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2026 ➔ Apr 2026

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

Study of Intravenous ZMA001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=7 | Suspended | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | N=96 ➔ 7 | Recruiting ➔ Suspended

Enrollment change • Trial suspension • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

FDA Grants Orphan Drug Designation (ODD) Status to Zymedi's ZMA001 for Pulmonary Arterial Hypertension (PRNewswire) - "Zymedi...announced that its first-in-class antibody treatment ZMA001, currently in development for pulmonary arterial hypertension (PAH), has been designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA)....According to Zymedi, ZMA001 is a human monoclonal antibody that blocks the infiltration of inflammation-inducing macrophages into the lungs, thereby fundamentally inhibiting the symptoms of PAH from the early stages....Phase 1a clinical trial for ZMA001 began at the NIH Clinical Center in January, involving healthy adult participants. This initial phase focuses on evaluating the safety and tolerability of the drug in humans."

Orphan drug • Trial status • Pulmonary Arterial Hypertension

Study of Intravenous ZMA001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Not yet recruiting ➔ Recruiting

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

Study of Intravenous ZMA001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

New P1 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases