HS235 / 35Pharma - LARVOL DELTA

HS235-002: Phase Ib Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIDE) (clinicaltrialsregister.eu) - P1 | N=14 | Not yet recruiting | Sponsor: 35Pharma Inc.

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

HS235-002: Phase Ib Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIDE) (clinicaltrialsregister.eu) - P1 | N=11 | Not yet recruiting | Sponsor: 35Pharma Inc.

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

HS235, A NEXT-GENERATION BMP-9/-10-SPARING ACTIVIN SIGNALING INHIBITOR FOR THE TREATMENT OF PULMONARY HYPERTENSION (PH) AND HEART FAILURE: RESULTS FROM A PHASE 1 HEALTHY VOLUNTEER TRIAL DEMONSTRATING FAVOURABLE SAFETY AND PHARMACODYNAMIC EFFECTS (ACC 2026) - "Abstract is embargoed at this time."

Clinical • P1 data • PK/PD data • Cardiovascular • Congestive Heart Failure • Heart Failure • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

HS235, a next-generation BMP-9/-10 sparing activin signaling inhibitor for pulmonary hypertension and heart failure: results from a phase 1 trial in healthy volunteers with overweight and obesity (HEART FAILURE 2026) - No abstract available

Clinical • P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure

Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: 35Pharma Inc | Recruiting ➔ Completed | N=64 ➔ 39

Enrollment change • Trial completion • Genetic Disorders • Obesity

HS235, a Novel Activin Signaling Inhibitor, is Highly Efficacious in Preclinical Models of Pulmonary Hypertension and Heart Failure (AHA 2025) - "Briefly, mice underwent TAC surgery, recovered for 2 weeks, and were then treated with vehicle, HS235, or wild-type ActRIIA-Fc (a sotatercept surrogate) for 4 weeks. HS235 improved PH, HF, body composition and exercise tolerance in in vivo models. These results demonstrate the differentiated therapeutic profile of HS235 and support its further development as a novel treatment of cardiopulmonary and cardiometabolic diseases."

Preclinical • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Metabolic Disorders • Obesity • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • ACVR2A

HS235, A Novel Lean Mass-Preserving Treatment for Obesogenic HF with Preserved Ejection Fraction (OBESITY WEEK 2025) - "These data demonstrate that HS235 represents a novel approach to treating obesity and associated co-morbidities in a manner that is complementary and orthogonal to currently approved incretin-based medications. Specifically, these data support the development of HS235 in obesogenic HFpEF and as a fat-selective anti-obesity agent."

Cardiovascular • Congestive Heart Failure • Fibrosis • Genetic Disorders • Heart Failure • Immunology • Obesity • TGFB1

HS235, a Novel Activin Signaling Inhibitor, is Highly Efficacious in Preclinical Models of Pulmonary Hypertension (PH) and Heart Failure (HF) (ERS 2025) - "HS235 improved PH, HF, metabolism and exercise tolerance in in vivo models. These results demonstrate the differentiated therapeutic profile of HS235 and support its further development as a novel treatment of cardiopulmonary and cardiometabolic diseases."

Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Metabolic Disorders • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • ACVR2A

A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: 35Pharma Inc

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

Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: 35Pharma Inc

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Obesity • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

HS235, A Novel Lean Mass-Preserving Treatment for Obesogenic Heart Failure with Preserved Ejection Fraction with Pleiotropic Metabolic Effects (ENDO 2025) - "These data demonstrate that HS235 represents a novel approach to treating obesity and associated co-morbidities in a manner that is complementary and orthogonal to currently approved incretin-based medications. Specifically, these data support the development of HS235 in obesogenic HFpEF and as a fat-selective anti-obesity agent."

Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Metabolic Disorders • Obesity • TGFB1

Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: 35Pharma Inc

New P1 trial • Genetic Disorders • Obesity