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Pulmonary Arterial Hypertension pipeline

According to DelveInsight’s analysis, the global PAH pipeline consists of more than 55 key companies working on over 55 therapeutic candidates. The report provides a thorough assessment of clinical trials, treatment strategies, mechanisms of action, administration routes, and recent advancements influencing the PAH treatment ecosystem.

The report titled “Pulmonary Arterial Hypertension Pipeline Insight, 2026” by DelveInsight offers a comprehensive overview of the current clinical landscape along with future opportunities expected to drive growth in the PAH market.

This pipeline analysis presents an extensive evaluation of both clinical and commercial aspects of drug candidates, covering stages from early discovery to marketed therapies. It also includes detailed drug profiles outlining mechanisms of action, clinical progress, regulatory milestones such as NDA approvals (if applicable), and key developments including partnerships, mergers and acquisitions, funding activities, technological innovations, and regulatory updates.

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Key Highlights from the Pulmonary Arterial Hypertension Pipeline Report:

• Companies across the globe are continuously investing in innovative therapies for PAH, with significant advancements achieved in recent years.
• Major pharmaceutical and biotechnology players such as Aerovate Therapeutics, Novartis, Keros Therapeutics, Vigonvita Life Sciences, Insmed Incorporated, Chugai Pharmaceutical, Merck Sharp & Dohme, Janssen Pharmaceutical, Actelion, Gossamer Bio, Lung Biotechnology PBC, United Therapeutics, Gilead Sciences, Acceleron Pharma, Eiger BioPharmaceuticals, and AstraZeneca are focused on developing next-generation PAH treatments.
• A number of promising pipeline therapies are advancing through different stages of clinical trials, including AV-101, LTP001, KER-012, TPN171H, Treprostinil Palmitil, Satralizumab, Sotatercept, Macitentan, ACT-293987, GB002 (seralutinib), Parenteral Treprostinil, Ralinepag, Selonsertib, ubenimex, Olaparib, among others, which are anticipated to reshape the future PAH treatment landscape.
• In December 2025, tiakis Biotech AG announced the successful completion of a comprehensive data package supporting the advancement of Tiprelestat into Phase II clinical trials for PAH. This follows positive preclinical GLP-tox results. Tiprelestat is a novel neutrophil elastase inhibitor and BMPR2 enhancer designed to reduce inflammation and reverse vascular remodeling in PAH patients.
• In November 2025, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) disclosed its plans to initiate a global Phase III trial for IKT-001 under the IMPROVE-PAH study, expected to begin in early 2026.
• Also in November 2025, Cereno Scientific applied for FDA approval to begin a global clinical study evaluating its oral drug candidate CS1, originally developed for seizure disorders, in PAH patients. If approved, the Phase IIb placebo-controlled study is projected to commence in the first half of 2026 in partnership with a global CRO.
• In September 2025, AllRock Bio Inc. raised $50 million in Series A funding, co-led by Versant Ventures and Westlake BioPartners, to support the advancement of ROC-101, an oral pan-ROCK inhibitor licensed from Sanofi, into Phase II trials for PAH and ILD-PH.
• In August 2025, VASTHERA Co., Ltd. received FDA IND approval to initiate a Phase I clinical trial for VTB-10, a first-in-class Chemzyme designed to mimic peroxiredoxin activity and target oxidative stress in PAH.
• In March 2025, Merck (NYSE: MRK), known as MSD outside North America, announced results from the Phase III ZENITH trial of WINREVAIR™ (sotatercept-csrk), demonstrating a 76% reduction in the risk of major morbidity and mortality compared to placebo in high-risk PAH patients.
• Earlier, in January 2025, Merck released preliminary findings from the same ZENITH study, highlighting strong clinical benefits of WINREVAIR in patients classified under WHO functional class III/IV.
• In October 2024, Inhibikase Therapeutics, Inc. secured $110 million through a private placement to fund its Phase IIb ‘702’ clinical trial and support additional corporate initiatives.

Pulmonary Arterial Hypertension Overview

Pulmonary Arterial Hypertension is a rare and progressive condition marked by elevated blood pressure in the pulmonary arteries. This increased pressure puts significant strain on the right side of the heart, leading to symptoms such as shortness of breath, fatigue, chest pain, and swelling in the extremities. PAH can develop due to unknown causes, genetic predisposition, or as a result of other conditions such as connective tissue disorders or congenital heart defects. Although there is no definitive cure, existing treatment approaches—including medications, oxygen therapy, and lifestyle changes—help manage symptoms and improve quality of life.

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Emerging Drugs in the Pulmonary Arterial Hypertension Pipeline

Several innovative therapies are currently being investigated across various clinical stages, including:

• TYVASO / TYVASO DPI / TREPROST (treprostinil) – United Therapeutics / Mochida Pharmaceutical
• OPSYNVI / YUVANCI (macitentan + tadalafil) – Johnson & Johnson
• WINREVAIR (sotatercept) – Merck
• UPTRAVI (selexipag) – Johnson & Johnson / Nippon Shinyaku
• AV-101 – Aerovate Therapeutics
• LTP001 – Novartis
• KER-012 – Keros Therapeutics
• TPN171H – Vigonvita Life Sciences
• Treprostinil Palmitil – Insmed Incorporated
• Satralizumab – Chugai Pharmaceutical
• Sotatercept – Merck Sharp & Dohme
• Macitentan – Janssen Pharmaceutical
• ACT-293987 – Actelion
• GB002 (seralutinib) – Gossamer Bio
• Parenteral Treprostinil – Lung Biotechnology PBC
• Ralinepag – United Therapeutics
• Selonsertib – Gilead Sciences
• Sotatercept – Acceleron Pharma
• ubenimex – Eiger BioPharmaceuticals
• Olaparib – AstraZeneca

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Pulmonary Arterial Hypertension Route of Administration and Molecule Classification

The Pulmonary Arterial Hypertension pipeline includes therapies delivered through various routes such as oral, parenteral, intravitreal, subretinal, and topical methods.

These therapies are also categorized based on molecular types, including monoclonal antibodies, peptides, polymers, small molecules, and gene-based treatments.

Pulmonary Arterial Hypertension Pipeline Segmentation

The report categorizes more than 55 pipeline candidates across different development stages:

• Phase III (advanced stage)
• Phase II (mid-stage)
• Phase I (early-stage)
• Preclinical and discovery phases
• Discontinued or inactive programs

Pulmonary Arterial Hypertension Market Drivers

• Rising global incidence of PAH
• A robust and expanding pipeline of therapies
• Development of innovative drug combinations

Pulmonary Arterial Hypertension Market Challenges

• High cost of treatment
• Low awareness in emerging markets
• Issues related to access and reimbursement

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Scope of the Pulmonary Arterial Hypertension Market Report

• Global: coverage
• Key Pulmonary Arterial Hypertension companies include Aerovate Therapeutics, Novartis, Keros Therapeutics, Vigonvita Life Sciences, Insmed Incorporated, Chugai Pharmaceutical, Merck Sharp & Dohme, Janssen Pharmaceutical, Actelion, Gossamer Bio, Lung Biotechnology PBC, United Therapeutics, Gilead Sciences, Acceleron Pharma, Eiger BioPharmaceuticals, AstraZeneca, and others
• Key Pulmonary Arterial Hypertension therapies include AV-101, LTP001, KER-012, TPN171H, Treprostinil Palmitil, Satralizumab, Sotatercept, Macitentan, ACT-293987, GB002 (seralutinib), Parenteral Treprostinil, Ralinepag, Selonsertib, ubenimex, Olaparib, among others
• Covers both marketed and emerging therapies
• Includes detailed analysis of market drivers and barriers

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Table of Contents

1. Introduction to the PAH Report
2. Executive Overview
3. Disease Overview
4. Analytical and Commercial Assessment
5. Pipeline Therapeutics Overview
6. Late-Stage Pipeline Products
7. Mid-Stage Pipeline Products
8. Early-Stage Pipeline Products
9. Preclinical Candidates
10. Therapeutic Evaluation
11. Inactive or Discontinued Products
12. Collaboration and Licensing Analysis
13. Key Companies
14. Key Therapies
15. Unmet Needs
16. Market Drivers and Challenges
17. Future Outlook and Conclusions
18. Analyst Insights
19. Appendix
20. About DelveInsight

About DelveInsight

DelveInsight is a prominent business consulting and market research firm specializing in the life sciences sector. The company assists pharmaceutical organizations by delivering comprehensive solutions aimed at enhancing performance. Additionally, it provides healthcare consulting services that support market analysis, enabling businesses to accelerate growth and effectively address industry challenges.

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