Pulmonary Arterial Hypertension Pipeline Analysis Report 2025
Description
Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure in the arteries of the lungs. In 2021, there were an estimated 192,000 prevalent cases of pulmonary arterial hypertension worldwide. The pulmonary arterial hypertension treatment market is expanding due to a growing focus on novel drug development and targeted therapies. Pulmonary arterial hypertension pipeline analysis by Expert Market Research highlights a robust pipeline of innovative drugs, including endothelin receptor antagonists and prostacyclin analogs. Increasing R&D investments, rising awareness, and improved diagnostic tools are expected to accelerate the clinical development of pulmonary arterial hypertension therapeutic products in the coming years.
Report Coverage
The Pulmonary Arterial Hypertension Pipeline Analysis Report by Expert Market Research gives comprehensive insights into pulmonary arterial hypertension therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for pulmonary arterial hypertension. The pulmonary arterial hypertension report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The pulmonary arterial hypertension pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with pulmonary arterial hypertension treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to pulmonary arterial hypertension.
Pulmonary Arterial Hypertension Pipeline Outlook
Pulmonary arterial hypertension (PAH) is a rare, progressive condition characterized by high blood pressure in the arteries of the lungs. It occurs when the pulmonary arteries thicken and narrow, restricting blood flow and causing strain on the right side of the heart, which may eventually lead to heart failure.
Pulmonary arterial hypertension is treated through vasodilators, endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs, aimed at lowering pulmonary pressure, improving symptoms, and delaying disease progression. In March 2024, the U.S. Food and Drug Administration approved Winrevair (Sotatercept-csrk) as a first-in-class therapy for adults with PAH. It significantly improved exercise capacity and reduced clinical worsening when added to background treatment.
Pulmonary Arterial Hypertension Epidemiology
A study revealed that in 2021, there were approximately 192,000 prevalent cases of pulmonary arterial hypertension (PAH) worldwide, with 62% in females and 38% in males. The age-standardised prevalence was 2.28 per 100,000 population, highest among individuals aged 75–79 years. There were 22,000 deaths, and years of life lost (YLLs) improved by 38.2% since 1990. These findings highlight a gradual reduction in PAH’s global burden and improved disease management.
Pulmonary Arterial Hypertension – Pipeline Therapeutic Assessment
This section of the report covers the analysis of pulmonary arterial hypertension drug candidates based on several segmentations, including:
By Phase
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II accounts for 45.83% of the pulmonary arterial hypertension pipeline, indicating a strong focus on mid-stage clinical development. Phase III holds 22.5%, phase I 15.83%, phase IV 13.33%, and early phase I 2.5%. This balanced progression highlights active innovation and regulatory advancement, positively influencing market growth and offering potential for improved patient outcomes.
Pulmonary Arterial Hypertension Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the pulmonary arterial hypertension pipeline analysis include small molecules, biologics, gene therapies, RNA-based therapies, natural products & derivatives, and others. The pulmonary arterial hypertension report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for pulmonary arterial hypertension.
Kinase inhibitors are emerging as a promising drug class in the pulmonary arterial hypertension pipeline. For instance, IkT-001Pro, a prodrug of imatinib mesylate, is under development by Inhibikase Therapeutics. The U.S. Food and Drug Administration has designated it as a New Molecular Entity, acknowledging its potential to modify disease progression rather than merely alleviate symptoms.
Pulmonary Arterial Hypertension Clinical Trials – Key Players
The EMR report for the pulmonary arterial hypertension pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed pulmonary arterial hypertension therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in pulmonary arterial hypertension clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for pulmonary arterial hypertension. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of pulmonary arterial hypertension drug candidates.
Drug: Adempas (Riociguat, BAY63-2521)
Riociguat (Adempas, BAY63-2521), sponsored by Bayer, is in a Phase IV long-term extension study (RIALTO) for symptomatic pulmonary arterial hypertension. The study aims to examine the long-term safety, tolerability, and efficacy of orally administered Riociguat, a soluble guanylate cyclase stimulator that promotes vasodilation and vascular remodeling.
Drug: APL-9796
APL-9796 is being evaluated by Apollo Therapeutics Ltd in a Phase II trial (ViTAL-PH) to assess its safety, tolerability, and potential effectiveness in treating pulmonary hypertension (PH). The study is examining multiple subcutaneous doses of APL-9796, a ZIP12 protein inhibitor, which has shown promising results in preclinical models by reducing ZIP12 activity, believed to contribute to PH progression.
Drug: PF-07868489
PF-07868489 is being sponsored by Pfizer for the treatment of pulmonary arterial hypertension (PAH). It is a recombinant human IgG1 targeting BMP9, and it is being administered subcutaneously in both healthy individuals and PAH patients. This ongoing Phase I/II trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-07868489.
Key Questions Answered in the Pulmonary Arterial Hypertension Pipeline Analysis Report
The Pulmonary Arterial Hypertension Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for pulmonary arterial hypertension. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into pulmonary arterial hypertension collaborations, regulatory environments, and potential growth opportunities.
Related Reports
Pulmonary Arterial Hypertension Market Report
Pulmonary Arterial Hypertension Epidemiology Forecast
Global Clinical Trials Market
Report Coverage
The Pulmonary Arterial Hypertension Pipeline Analysis Report by Expert Market Research gives comprehensive insights into pulmonary arterial hypertension therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for pulmonary arterial hypertension. The pulmonary arterial hypertension report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The pulmonary arterial hypertension pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with pulmonary arterial hypertension treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to pulmonary arterial hypertension.
Pulmonary Arterial Hypertension Pipeline Outlook
Pulmonary arterial hypertension (PAH) is a rare, progressive condition characterized by high blood pressure in the arteries of the lungs. It occurs when the pulmonary arteries thicken and narrow, restricting blood flow and causing strain on the right side of the heart, which may eventually lead to heart failure.
Pulmonary arterial hypertension is treated through vasodilators, endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs, aimed at lowering pulmonary pressure, improving symptoms, and delaying disease progression. In March 2024, the U.S. Food and Drug Administration approved Winrevair (Sotatercept-csrk) as a first-in-class therapy for adults with PAH. It significantly improved exercise capacity and reduced clinical worsening when added to background treatment.
Pulmonary Arterial Hypertension Epidemiology
A study revealed that in 2021, there were approximately 192,000 prevalent cases of pulmonary arterial hypertension (PAH) worldwide, with 62% in females and 38% in males. The age-standardised prevalence was 2.28 per 100,000 population, highest among individuals aged 75–79 years. There were 22,000 deaths, and years of life lost (YLLs) improved by 38.2% since 1990. These findings highlight a gradual reduction in PAH’s global burden and improved disease management.
Pulmonary Arterial Hypertension – Pipeline Therapeutic Assessment
This section of the report covers the analysis of pulmonary arterial hypertension drug candidates based on several segmentations, including:
By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
- Small Molecules
- Biologics
- Gene Therapies
- RNA-based Therapies
- Natural Products & Derivatives
- Others
- Oral
- Parenteral
- Others
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II accounts for 45.83% of the pulmonary arterial hypertension pipeline, indicating a strong focus on mid-stage clinical development. Phase III holds 22.5%, phase I 15.83%, phase IV 13.33%, and early phase I 2.5%. This balanced progression highlights active innovation and regulatory advancement, positively influencing market growth and offering potential for improved patient outcomes.
Pulmonary Arterial Hypertension Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the pulmonary arterial hypertension pipeline analysis include small molecules, biologics, gene therapies, RNA-based therapies, natural products & derivatives, and others. The pulmonary arterial hypertension report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for pulmonary arterial hypertension.
Kinase inhibitors are emerging as a promising drug class in the pulmonary arterial hypertension pipeline. For instance, IkT-001Pro, a prodrug of imatinib mesylate, is under development by Inhibikase Therapeutics. The U.S. Food and Drug Administration has designated it as a New Molecular Entity, acknowledging its potential to modify disease progression rather than merely alleviate symptoms.
Pulmonary Arterial Hypertension Clinical Trials – Key Players
The EMR report for the pulmonary arterial hypertension pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed pulmonary arterial hypertension therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in pulmonary arterial hypertension clinical trials:
- Pfizer
- Insmed Incorporated
- Novartis Pharmaceuticals
- Bayer
- Actelion Pharmaceuticals Ltd.
- GB002, Inc.
- Apollo Therapeutics Ltd.
- 35Pharma Inc.
- Guangzhou Magpie Pharmaceuticals, Inc.
- ABLi Therapeutics, Inc.
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for pulmonary arterial hypertension. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of pulmonary arterial hypertension drug candidates.
Drug: Adempas (Riociguat, BAY63-2521)
Riociguat (Adempas, BAY63-2521), sponsored by Bayer, is in a Phase IV long-term extension study (RIALTO) for symptomatic pulmonary arterial hypertension. The study aims to examine the long-term safety, tolerability, and efficacy of orally administered Riociguat, a soluble guanylate cyclase stimulator that promotes vasodilation and vascular remodeling.
Drug: APL-9796
APL-9796 is being evaluated by Apollo Therapeutics Ltd in a Phase II trial (ViTAL-PH) to assess its safety, tolerability, and potential effectiveness in treating pulmonary hypertension (PH). The study is examining multiple subcutaneous doses of APL-9796, a ZIP12 protein inhibitor, which has shown promising results in preclinical models by reducing ZIP12 activity, believed to contribute to PH progression.
Drug: PF-07868489
PF-07868489 is being sponsored by Pfizer for the treatment of pulmonary arterial hypertension (PAH). It is a recombinant human IgG1 targeting BMP9, and it is being administered subcutaneously in both healthy individuals and PAH patients. This ongoing Phase I/II trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-07868489.
Key Questions Answered in the Pulmonary Arterial Hypertension Pipeline Analysis Report
- Which companies/institutions are leading the pulmonary arterial hypertension drug development?
- What is the efficacy and safety profile of pulmonary arterial hypertension pipeline drugs?
- Which company is leading the pulmonary arterial hypertension pipeline development activities?
- What is the current pulmonary arterial hypertension commercial assessment?
- What are the opportunities and challenges present in the pulmonary arterial hypertension pipeline landscape?
- What is the efficacy and safety profile of pulmonary arterial hypertension pipeline drugs?
- Which company is conducting major trials for pulmonary arterial hypertension drugs?
- Which companies/institutions are involved in pulmonary arterial hypertension collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in pulmonary arterial hypertension?
The Pulmonary Arterial Hypertension Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for pulmonary arterial hypertension. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into pulmonary arterial hypertension collaborations, regulatory environments, and potential growth opportunities.
Related Reports
Pulmonary Arterial Hypertension Market Report
Pulmonary Arterial Hypertension Epidemiology Forecast
Global Clinical Trials Market
Table of Contents
200 Pages
- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Pulmonary Arterial Hypertension
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Pulmonary Arterial Hypertension
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Pulmonary Arterial Hypertension: Epidemiology Snapshot
- 5.1 Pulmonary Arterial Hypertension Incidence by Key Markets
- 5.2 Pulmonary Arterial Hypertension – Patients Seeking Treatment in Key Markets
- 6 Pulmonary Arterial Hypertension: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Pulmonary Arterial Hypertension: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Pulmonary Arterial Hypertension, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Pulmonary Arterial Hypertension Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Pulmonary Arterial Hypertension Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
- 10.1 Comparative Analysis for Late-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: Adempas (Riociguat, BAY63-2521)
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Drug: Macitentan
- 10.2.3 Drug: Seralutinib
- 10.2.4 Drug: Treprostinil Palmitil
- 10.2.5 Other Drugs
- 11 Pulmonary Arterial Hypertension Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: APL-9796
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Drug: IkT-001Pro
- 11.2.3 Drug: PF-07868489
- 11.2.4 Drug: LTP001
- 11.2.5 Other Drugs
- 12 Pulmonary Arterial Hypertension Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Biological: HS135
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Drug: MN-08
- 12.2.3 Other Drugs
- 13 Pulmonary Arterial Hypertension Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
- 13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
- 13.1.1 Study Type
- 13.1.2 Recruitment Status
- 13.1.3 Company
- 13.1.4 Funder Type
- 13.2 Product Level Analysis*
- 13.2.1 Drug 1
- 13.2.1.1 Product Description
- 13.2.1.2 Trial ID
- 13.2.1.3 Sponsor Name
- 13.2.1.4 Study Type
- 13.2.1.5 Drug Class
- 13.2.1.6 Eligibility Criteria
- 13.2.1.7 Study Record Dates
- 13.2.1.7.1 First Submitted
- 13.2.1.7.2 First Posted
- 13.2.1.7.3 Last Update Posted
- 13.2.1.7.4 Last Verified
- 13.2.1.8 Indication
- 13.2.1.9 Study Design
- 13.2.1.10 Recruitment Status
- 13.2.1.11 Enrollment (Estimated)
- 13.2.1.12 Location Countries
- 13.2.2 Other Drugs
- 14 Pulmonary Arterial Hypertension, Key Drug Pipeline Companies
- 14.1 Pfizer
- 14.1.1 Company Snapshot
- 14.1.2 Pipeline Product Portfolio
- 14.1.3 Financial Analysis
- 14.1.4 Recent News and Developments
- 14.2 Insmed Incorporated
- 14.2.1 Company Snapshot
- 14.2.2 Pipeline Product Portfolio
- 14.2.3 Financial Analysis
- 14.2.4 Recent News and Developments
- 14.3 Novartis Pharmaceuticals
- 14.3.1 Company Snapshot
- 14.3.2 Pipeline Product Portfolio
- 14.3.3 Financial Analysis
- 14.3.4 Recent News and Developments
- 14.4 Bayer
- 14.4.1 Company Snapshot
- 14.4.2 Pipeline Product Portfolio
- 14.4.3 Financial Analysis
- 14.4.4 Recent News and Developments
- 14.5 Actelion Pharmaceuticals Ltd.
- 14.5.1 Company Snapshot
- 14.5.2 Pipeline Product Portfolio
- 14.5.3 Financial Analysis
- 14.5.4 Recent News and Developments
- 14.6 GB002, Inc.
- 14.6.1 Company Snapshot
- 14.6.2 Pipeline Product Portfolio
- 14.6.3 Financial Analysis
- 14.6.4 Recent News and Developments
- 14.7 Apollo Therapeutics Ltd.
- 14.7.1 Company Snapshot
- 14.7.2 Pipeline Product Portfolio
- 14.7.3 Financial Analysis
- 14.7.4 Recent News and Developments
- 14.8 35Pharma Inc.
- 14.8.1 Company Snapshot
- 14.8.2 Pipeline Product Portfolio
- 14.8.3 Financial Analysis
- 14.8.4 Recent News and Developments
- 14.9 Guangzhou Magpie Pharmaceuticals, Inc.
- 14.9.1 Company Snapshot
- 14.9.2 Pipeline Product Portfolio
- 14.9.3 Financial Analysis
- 14.9.4 Recent News and Developments
- 14.10 ABLi Therapeutics, Inc.
- 14.10.1 Company Snapshot
- 14.10.2 Pipeline Product Portfolio
- 14.10.3 Financial Analysis
- 14.10.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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