Pulmonary Arterial Hypertension Pipeline 2025: Key Companies, MOA, ROA, and Clinical Trials Evaluation by DelveInsight | Ribomic, Gmax Biopharm, Novartis, Cereno Scientific AB, Insmed Incorporated

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Pulmonary Arterial Hypertension pipeline constitutes 55+ key companies continuously working towards developing 55+ Pulmonary Arterial Hypertension treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Pulmonary Arterial Hypertension Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/pulmonary-arterial-hypertension-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Pulmonary Arterial Hypertension Market.

The Pulmonary Arterial Hypertension Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Pulmonary Arterial Hypertension Pipeline Report:

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Companies across the globe are diligently working toward developing novel Pulmonary Arterial Hypertension treatment therapies with a considerable amount of success over the years.

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Pulmonary Arterial Hypertension companies working in the treatment market are 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, are developing therapies for the Pulmonary Arterial Hypertension treatment

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Emerging Pulmonary Arterial Hypertension therapies in the different phases of clinical trials are- 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 are expected to have a significant impact on the Pulmonary Arterial Hypertension market in the coming years.

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In December 2025, tiakis Biotech AG ("tiakis"), a clinical-stage biopharmaceutical company focused on developing innovative therapies for severe pulmonary and cardiovascular conditions, announced the completion of a comprehensive data package to advance Tiprelestat into a Phase II clinical trial for Pulmonary Arterial Hypertension (PAH) following a preclinical GLP-tox study. Tiprelestat, a first-in-class biological neutrophil elastase inhibitor and BMPR2 amplifier, is being developed as a disease-modifying therapy for PAH, with the potential to reduce underlying inflammation and reverse vascular remodeling associated with this rare and life-threatening disease.

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In November 2025, Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage company focused on developing therapies for cardiopulmonary diseases such as pulmonary arterial hypertension (PAH), announced plans to advance IKT-001 into a global pivotal Phase 3 clinical trial. The study, titled IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), is anticipated to begin in the first quarter of 2026.

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In November 2025, Cereno Scientific is seeking FDA approval to initiate a global clinical trial of its oral therapy CS1-a repurposed seizure medication-for patients with pulmonary arterial hypertension (PAH). The company aims to evaluate whether CS1 can enhance quality of life and improve survival in PAH. The trial protocol has been submitted to the FDA, and if approved, the study is expected to start in the first half of 2026 following the standard 30-day regulatory review. The Phase 2b trial will compare CS1 with a placebo at international sites, conducted in partnership with a leading global contract research organization (CRO).

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In November 2025, Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage biopharmaceutical company focused on developing treatments for cardiopulmonary diseases such as pulmonary arterial hypertension (PAH), announced that it plans to advance IKT-001 into a global pivotal Phase 3 clinical trial for PAH. The Phase 3 study, titled IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), is expected to begin in the first quarter of 2026.

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In September 2025, AllRock Bio Inc., a clinical-stage biotech company developing therapies for cardiopulmonary and fibrotic diseases, announced a $50 million Series A financing round co-led by Versant Ventures and Westlake BioPartners. The funding will support the advancement of its lead candidate, ROC-101-an oral, first-in-class pan-rho-associated protein kinase (ROCK) inhibitor exclusively licensed from Sanofi-into Phase 2 clinical trials. ROC-101 is being developed to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD-PH), both life-threatening conditions with poor five-year survival rates of 57% and 38%. By targeting inflammatory, proliferative, and fibrotic remodeling driven by both ROCK1 and ROCK2, ROC-101 holds promise to meet a major unmet need in these patient populations.

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In August 2025, Cereno Scientific's lead candidate, CS1, has been granted FDA Fast Track designation for pulmonary arterial hypertension, acknowledging its promise as a novel and potentially disease-modifying therapy for this rare and severe condition.

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In August 2025, VASTHERA Co., Ltd. announced FDA clearance of its Investigational New Drug (IND) application to begin a Phase 1 trial for VTB-10, a novel candidate for pulmonary arterial hypertension (PAH). Developed via the company's proprietary Redoxizyme Trademark platform, VTB-10 is a first-in-class small molecule enzyme (Chemzyme) designed to mimic the function of peroxiredoxin (PRX), which is deficient in PAH lesions. Preclinical data showed that VTB-10 not only reversed abnormal vascular remodeling but also restored healthy endothelial function, offering a dual mechanism of action that sets it apart from current treatment options.

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In March 2025, Merck (NYSE: MRK), operating as MSD outside the U.S. and Canada, has unveiled the first results from its Phase 3 ZENITH trial assessing WINREVAIR Trademark (sotatercept-csrk) versus placebo in adults with pulmonary arterial hypertension (PAH, Group 1 PH), specifically those in WHO functional class III or IV with a high risk of mortality who were receiving maximum tolerated background therapy. At a median follow-up of 10.6 months (ranging from 0.3 to 26.1 months), WINREVAIR demonstrated a 76% reduction in the relative risk of major morbidity and mortality events-including all-cause death, lung transplant, and PAH-related hospitalization of greater than or equal to 24 hours-compared to placebo (HR=0.24 [95% CI, 0.13-0.43]; p



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