According to DelveInsight, the global Pulmonary Arterial Hypertension (PAH) pipeline features more than 55 prominent companies actively advancing over 55 therapeutic candidates. The analysis comprehensively reviews clinical trials, therapeutic approaches, mechanisms of action, routes of administration, and recent developments shaping the PAH landscape.
The “Pulmonary Arterial Hypertension Pipeline Insight, 2026” report from DelveInsight delivers an in-depth evaluation of the current clinical development environment and future growth opportunities within the PAH market.
This PAH pipeline study provides a detailed commercial and clinical evaluation of drug candidates, spanning from preclinical research to marketed products. It also includes extensive drug profiles covering mechanisms of action, clinical trial progress, NDA approvals (where applicable), and development activities such as technological advancements, collaborations, mergers and acquisitions, funding events, regulatory designations, and other product-specific updates.
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Major Highlights from the Pulmonary Arterial Hypertension Pipeline Report:
- Companies worldwide are consistently pursuing innovative PAH therapies, achieving notable progress in recent years.
- Leading pharmaceutical and biotech firms—including 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 actively developing next-generation PAH treatments.
- Promising investigational therapies progressing through various trial phases include AV-101, LTP001, KER-012, TPN171H, Treprostinil Palmitil, Satralizumab, Sotatercept, Macitentan, ACT-293987, GB002 (seralutinib), Parenteral Treprostinil, Ralinepag, Selonsertib, ubenimex, Olaparib, and others, all of which are expected to influence the PAH treatment landscape in the years ahead.
- In December 2025, tiakis Biotech AG announced completion of a comprehensive data package supporting advancement of Tiprelestat into a Phase II clinical trial for PAH following successful preclinical GLP-tox studies. Tiprelestat, a first-in-class biological neutrophil elastase inhibitor and BMPR2 amplifier, is being developed as a disease-modifying treatment aimed at reducing inflammation and reversing vascular remodeling associated with PAH.
- In November 2025, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) revealed plans to initiate a global pivotal Phase III trial for IKT-001 under the IMPROVE-PAH study, anticipated to commence in early 2026.
- Also in November 2025, Cereno Scientific sought FDA clearance to launch a global clinical study evaluating its oral candidate CS1, a repurposed seizure medication, in PAH patients. If approved, the Phase IIb placebo-controlled trial is expected to begin in the first half of 2026 in collaboration with a global CRO.
- In September 2025, AllRock Bio Inc. secured $50 million in Series A funding co-led by Versant Ventures and Westlake BioPartners to advance ROC-101, an oral pan-ROCK inhibitor licensed from Sanofi, into Phase II development for PAH and ILD-PH.
- In August 2025, VASTHERA Co., Ltd. received FDA IND clearance to begin a Phase I study of VTB-10, a first-in-class Chemzyme designed to mimic peroxiredoxin function and address oxidative stress in PAH lesions.
- In March 2025, Merck (NYSE: MRK), operating as MSD outside North America, released Phase III ZENITH trial results for WINREVAIR™ (sotatercept-csrk), demonstrating a 76% relative risk reduction in major morbidity and mortality events compared to placebo among high-risk PAH patients.
- Earlier, in January 2025, Merck shared preliminary findings from the same Phase III ZENITH study, reinforcing the significant clinical benefit of WINREVAIR in WHO functional class III/IV PAH patients.
- In October 2024, Inhibikase Therapeutics, Inc. completed a $110 million private placement to fund its Phase IIb ‘702’ trial in PAH and support broader corporate initiatives.
Pulmonary Arterial Hypertension Overview
Pulmonary Arterial Hypertension is an uncommon, progressive disorder characterized by elevated blood pressure within the pulmonary arteries. This increased vascular pressure places strain on the right ventricle, leading to symptoms such as dyspnea, fatigue, chest discomfort, and peripheral edema. PAH may arise idiopathically, genetically, or secondary to other medical conditions including connective tissue diseases or congenital heart abnormalities. Although curative treatments are not yet available, current management strategies—including pharmacotherapy, oxygen supplementation, and lifestyle modification—can alleviate symptoms and improve patient outcomes.
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Pulmonary Arterial Hypertension Emerging Drugs in Development
Innovative PAH therapies under investigation across clinical phases include:
- TYVASO/TYVASO DPI/TREPROST Inhalation Solution (treprostinil): United Therapeutics/Mochida Pharmaceutical
- OPSYNVI/YUVANCI (macitentan and 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 (Genetical Recombination): 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
Further Pulmonary Arterial Hypertension product details are provided in the report. Download the Pulmonary Arterial Hypertension pipeline report to learn more about the emerging Pulmonary Arterial Hypertension therapies
Pulmonary Arterial Hypertension Route of Administration & Molecule Classification
The PAH pipeline is categorized by multiple routes of administration, including oral, parenteral, intravitreal, subretinal, and topical delivery systems.
Therapies are further segmented by molecular type, such as monoclonal antibodies, peptides, polymers, small molecules, and gene therapies.
Pulmonary Arterial Hypertension Pipeline Segmentation
The report evaluates over 55 pipeline assets across:
- Phase III (late-stage)
- Phase II (mid-stage)
- Phase I (early-stage)
- Preclinical and discovery stages
- Discontinued or inactive programs
Pulmonary Arterial Hypertension Market Drivers
- Increasing global prevalence of PAH
- Strong and expanding therapeutic pipeline
- Novel drug combinations entering development
Pulmonary Arterial Hypertension Market Barriers
- High treatment costs
- Limited awareness in developing regions
- Access and reimbursement challenges
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Scope of Pulmonary Arterial Hypertension Pipeline Drug Insight
- Coverage: Global
- Key Pulmonary Arterial Hypertension Companies: 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 Science, Acceleron Pharma, Eiger BioPharmaceuticals, AstraZeneca, and others
- Key Pulmonary Arterial Hypertension Therapies: AV-101, LTP001, KER-012, TPN171H, Treprostinil Palmitil, Satralizumab (Genetical Recombination), Sotatercept, Macitentan, ACT-293987, GB002 (seralutinib), Parenteral Treprostinil, Ralinepag, Selonsertib, Sotatercept, ubenimex, Olaparib, and others
- Pulmonary Arterial Hypertension Therapeutic Assessment: Pulmonary Arterial Hypertension current marketed and Pulmonary Arterial Hypertension emerging therapies
- Pulmonary Arterial Hypertension Market Dynamics: Pulmonary Arterial Hypertension market drivers and Pulmonary Arterial Hypertension market barriers
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Table of Contents
1. Pulmonary Arterial Hypertension Report Introduction
2. Pulmonary Arterial Hypertension Executive Summary
3. Pulmonary Arterial Hypertension Overview
4. Pulmonary Arterial Hypertension- Analytical Perspective In-depth Commercial Assessment
5. Pulmonary Arterial Hypertension Pipeline Therapeutics
6. Pulmonary Arterial Hypertension Late Stage Products (Phase II/III)
7. Pulmonary Arterial Hypertension Mid Stage Products (Phase II)
8. Pulmonary Arterial Hypertension Early Stage Products (Phase I)
9. Pulmonary Arterial Hypertension Preclinical Stage Products
10. Pulmonary Arterial Hypertension Therapeutics Assessment
11. Pulmonary Arterial Hypertension Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Pulmonary Arterial Hypertension Key Companies
14. Pulmonary Arterial Hypertension Key Products
15. Pulmonary Arterial Hypertension Unmet Needs
16 . Pulmonary Arterial Hypertension Market Drivers and Barriers
17. Pulmonary Arterial Hypertension Future Perspectives and Conclusion
18. Pulmonary Arterial Hypertension Analyst Views
19. Appendix
20. About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach
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