mosliciguat (BAY1237592) / Bayer, Roivant - LARVOL DELTA

PHocus: Advancing The Clinical Development Of Inhaled Mosliciguat in PH-ILD (ERS 2026) - "Sponsored by Pulmovant"

Clinical • Interstitial Lung Disease

Mosliciguat in PH-ILD: Scientific Rationale, Mechanism of Action, and Insights From The Ph1b ATMOS Program (ERS 2026) - "Sponsored by Pulmovant"

Interstitial Lung Disease

SESSION 502 PHocus Phase 2 clinical trial of inhaled mosliciguat, a novel sGC activator, in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) (ERS 2026) - "Sponsored by Pulmovant"

Clinical • P2 data • Cardiovascular • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Functional respiratory imaging (FRI)-derived changes in pulmonary vascular morphology following single-dose inhaled mosliciguat in a Phase 1 open-label study in healthy volunteers (ERS 2026) - P1 | "Single-dose inhaled mosliciguat 4 mg in healthy volunteers increased pulmonary arterial volume, consistent with its mechanism. These findings support further evaluation of inhaled mosliciguat using FRI in a larger study in participants with PH associated with interstitial lung disease."

Clinical • P1 data • Cardiovascular • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Phase 1b ATMOS trial of the inhaled sGC activator mosliciguat in patients with PAH/CTEPH. (PubMed, Thorax) - P1 | "Mosliciguat demonstrated a favourable safety profile and sustained, clinically meaningful reductions in PVR in participants with PH."

Journal • P1 data • Cardiovascular • Fatigue • Hypertension • Inflammation • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases

A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier) (clinicaltrials.gov) - P3 | N=376 | Recruiting | Sponsor: Pulmovant, Inc.

New P3 trial • Cardiovascular • Hypertension • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

PHocus: A Study of Mosliciguat in PH-ILD (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Pulmovant, Inc. | Trial primary completion date: Dec 2026 ➔ May 2026

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

Safety and pharmacokinetics of mosliciguat, a new, inhaled soluble guanylate cyclase activator, in healthy adult subjects. (PubMed, Br J Clin Pharmacol) - "Mosliciguat DPI was well tolerated in healthy subjects, without AEs related to bronchospasm or airway irritation, with a pharmacodynamic response indicating sGC activation and a bronchodilating action."

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

A Phase 1 Study of Mosliciguat in Healthy, Adult Males (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Pulmovant, Inc. | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Jul 2025 | Trial primary completion date: Mar 2026 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date

PHocus: A Study of Mosliciguat in PH-ILD (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Pulmovant, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Pulmovant: Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) fully enrolled, with topline data expected in the second half of calendar year 2026. (The Manila Times)

P2 data • Interstitial Lung Disease • Pulmonary Arterial Hypertension

A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Pulmovant, Inc.

New P2 trial • Cardiovascular • Hypertension • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Program-Specific Highlights and Updates (GlobeNewswire) - "Enrollment in the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track; Pulmovant plans to report topline data in the second half of calendar year 2026; Pulmovant also expects to imminently initiate a Phase 2 study (n=20) evaluating mosliciguat in combination with inhaled treprostinil in patients with PH-ILD."

New P2 trial • P2 data • Hypertension • Interstitial Lung Disease • Pulmonary Disease

A Phase 1 Study of Mosliciguat in Healthy, Adult Males (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Pulmovant, Inc.

New P1 trial

PHocus: a global Phase 2 study of inhaled mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) (ERS 2025) - P2 | "PHocus, currently enrolling patients with PH-ILD, will provide important clinical data about the therapeutic potential of QD inhaled mosliciguat via DPI."

Clinical • P2 data • Cardiovascular • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Pulmovant Receives Orphan Drug Designation in Japan for Mosliciguat for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) (GlobeNewswire) - "Mosliciguat is currently being evaluated in the Phase 2 PHocus clinical study (NCT06635850), a randomized, double-blind, placebo-controlled, global trial assessing its safety and efficacy in approximately 120 adult patients with PH-ILD. A study-in-progress poster outlining the design of PHocus will be presented at the European Respiratory Society (ERS) International Congress 2025 on September 28th."

Orphan drug • Trial status • Interstitial Lung Disease • Pulmonary Arterial Hypertension

Major Upcoming Milestones (GlobeNewswire) - "Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of...2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of...2027. Topline results for the Phase 2 trial in CS are expected in the second half of...2026. Roivant and Priovant will be hosting an upcoming investor event on brepocitinib at 1:00 p.m. ET on Tuesday, June 17, 2025; Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease (TED) data in the second half of calendar year 2025. Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025; Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of...2026"

Clinical data • New trial • Dermatomyositis • Grave’s Disease • Hypertension • Immunology • Sjogren's Syndrome • Thyroid Eye Disease • Uveitis

ATMOS, A Proof-of-Concept Trial of Inhaled Mosliciguat, A First-in-Class Soluble Guanylate Cyclase Activator - A Novel Approach to Address Unmet Needs in PH (ATS 2025) - "Phosphodiesterase 5 inhibitors and riociguat, an sGC stimulator, are approved for PH, but highly synergistic with functional, NO-responsive, heme-containing sGC. Mosliciguat had favorable tolerability and resulted in a sustained, substantial reduction in PVR after a single inhaled dose."

Cardiovascular • Fatigue • Inflammation • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases

Pharmacokinetics and Lung Deposition After Administration of Inhaled Mosliciguat (BAY 1237592): Results from Randomized Phase I Studies in Healthy Men. (PubMed, Clin Pharmacokinet) - "Inhaled mosliciguat had a longer tmax and half-life than oral mosliciguat. Accumulation data suggest formation of a mosliciguat depot in the lungs and continuous transfer to the systemic circulation, with an indication of an increase in accumulation ratio with longer duration of treatment."

Journal • P1 data • PK/PD data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business Update (GlobeNewswire) - "Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of calendar year 2027. Priovant’s Phase 2 trial of brepocitinib in cutaneous sarcoidosis is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026. Genevant litigation against Moderna continues to progress with summary judgment phase scheduled for second and third quarter of calendar year 2025; Moderna jury trial scheduled for September 2025."

New P2 trial • New trial • P2 data • P3 data • Dermatomyositis • Hypertension • Rare Diseases • Sarcoidosis • Uveitis

PHocus: A Phase 2 Study of Mosliciguat in PH-ILD (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Pulmovant, Inc.

New P2 trial • Cardiovascular • Hypertension • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

ATMOS, a Proof-of-Concept trial of inhaled mosliciguat in untreated PAH or CTEPH (ERS 2024) - "Mosliciguat had favorable tolerability and resulted in a sustained, substantial reduction in PVR after a single inhaled dose."

Fatigue • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases

The 10th International Conference on cGMP 2022: recent trends in cGMP research and development-meeting report. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The biannual international cGMP conference, launched nearly 20 years ago, brings all these aspects together as an established and important forum for all topics from basic science to clinical research and pivotal clinical trials. This review summarizes the contributions to the "10th cGMP Conference on cGMP Generators, Effectors and Therapeutic Implications," which was held in Augsburg in 2022 but will also provide an overview of recent key achievements and activities in the field of cGMP research."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Congestive Heart Failure • Coronary Artery Disease • Dementia • Erectile Dysfunction • Gastrointestinal Disorder • Genetic Disorders • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

ATMOS: This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Bayer | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases

Inhaled mosliciguat (BAY 1237592): targeting pulmonary vasculature via activating apo-sGC. (PubMed, Respir Res) - "Inhaled mosliciguat may overcome treatment limitations in patients with pulmonary hypertension by improving pulmonary circulation and airway resistance without systemic exposure or ventilation/perfusion mismatch. Mosliciguat has the potential to become a new therapeutic paradigm, exhibiting a unique mode of action and route of application, and is currently under clinical development in phase Ib for pulmonary hypertension."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases