Pulmonary Hypertension - Pipeline Insight, 2025

DelveInsight's, "Pulmonary Hypertension - Pipeline Insight, 2025" report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Pulmonary Hypertension pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Pulmonary Hypertension: Understanding

Pulmonary Hypertension: Overview

Pulmonary hypertension (PH) is a condition characterized by elevated pulmonary pressures and encompasses a wide range of disorders. The World Health Organization (WHO) classifies PH into five distinct clinical groups based on factors such as pathophysiology, hemodynamic characteristics, clinical features, and management. In addition to these clinical classifications, PH can also be categorized using a hemodynamic approach that aids in diagnosis. Specifically, a mean pulmonary artery pressure (mPAP) greater than 20 mm Hg is considered above the upper normal limit. However, mPAP elevation alone is not sufficient to diagnose PH, as it may result from increases in cardiac output or pulmonary artery wedge pressure (PAWP). To address this, the 6th World Symposium on Pulmonary Hypertension and the European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines further classify PH based on pulmonary vascular resistance (PVR) and PAWP, providing a more comprehensive framework for diagnosis and management.

Pulmonary hypertension (PH) can result from a variety of genetic, environmental, and underlying health conditions. Genetic mutations are linked to different types of PH, including idiopathic pulmonary arterial hypertension (IPAH), hereditary pulmonary arterial hypertension (HPAH), and hereditary hemorrhagic telangiectasia (HHT) associated with PAH. While individuals with HPAH carry inheritable mutations, IPAH is associated with sporadic genetic predispositions. Mutations in genes such as BMPR2, SMAD1, SMAD9, KCNK3, CAV1, and SOX17 are commonly found in IPAH/HPAH, while ALK1, ENG, and SMAD4 mutations are associated with HHT. Environmental and drug-induced factors also contribute to PAH, with substances like aminorex, methamphetamines, dasatinib, and certain cancer treatments known to trigger the condition. Connective tissue diseases (CTDs) like systemic sclerosis, lupus, and rheumatoid arthritis are recognized causes of PAH, with systemic sclerosis being particularly notorious for its association.

Pulmonary arterial hypertension (PAH) is characterized by progressive pulmonary vascular changes, including impaired vasodilation and abnormal smooth muscle proliferation, which result from disruptions in key signaling pathways: nitric oxide (NO), prostacyclin (PGI2), and endothelin-1 (ET-1). In PAH, decreased NO bioavailability leads to vasoconstriction and increased smooth muscle cell proliferation, while reduced PGI2 production shifts the balance towards thromboxane A2, promoting vasoconstriction and platelet aggregation. Additionally, ET-1 signaling is upregulated, contributing to vasoconstriction, smooth muscle hypertrophy, and fibrosis. These pathological alterations are counteracted by targeted therapies, including phosphodiesterase 5 inhibitors (PDE-5i), guanylate cyclase stimulators, prostacyclin analogs, and endothelin receptor antagonists (ERAs), which aim to restore normal vascular function and improve clinical outcomes.

The treatment of pulmonary hypertension (PH) has advanced significantly in recent years, focusing on improving patient function, quality of life, and minimizing mortality risk. Management involves a stepwise approach, starting with general supportive care, including supervised physical exercise, oxygen therapy, diuretics, and anticoagulation, to relieve symptoms and reduce complications. In patients with specific responses to vasoreactivity testing, high-dose calcium channel blockers (CCBs) may be used, particularly in idiopathic pulmonary arterial hypertension (IPAH). For those who do not respond to CCBs, targeted therapies are employed, such as phosphodiesterase-5 inhibitors (PDE-5i), guanylate cyclase stimulators, prostacyclin analogs, and endothelin receptor antagonists (ERAs). These therapies have been shown to improve exercise capacity and clinical outcomes, with studies indicating a significant reduction in mortality. Multidisciplinary care, including psychosocial support and genetic counseling, is essential for managing the complex aspects of PH and enhancing patient well-being.

"Pulmonary Hypertension- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Pulmonary Hypertension pipeline landscape is provided which includes the disease overview and Pulmonary Hypertension treatment guidelines. The assessment part of the report embraces, in depth Pulmonary Hypertension commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Pulmonary Hypertension collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Pulmonary Hypertension R&D. The therapies under development are focused on novel approaches to treat/improve Pulmonary Hypertension.

Pulmonary Hypertension Emerging Drugs Chapters

This segment of the Pulmonary Hypertension report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Pulmonary Hypertension Emerging Drugs

• Seralutinib: GB002, Inc.

Seralutinib is an investigational, inhaled, small molecule, platelet-derived growth factor receptor (PDGFR), colony-stimulating factor 1 receptor (CSF1R) and mast/stem cell growth factor receptor kit (c-KIT). It was intentionally designed to target the mechanisms that underlie pulmonary hypertension and to be delivered to the site of disease, via dry powder inhaler. Seralutinib is currently being evaluated in a phase 3 clinical trial for the treatment of pulmonary arterial hypertension (PAH). Seralutinib has also been granted Orphan Drug Designation for the treatment of PAH in US, Europe and Japan. Currently, the drug is in Phase III stage of its development for the treatment of Pulmonary Hypertension.

• TNX-103: Tenax Therapeutics, Inc.

Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action, and that is being developed as an oral therapy (TNX-103) for pulmonary hypertension (PH) with heart failure with preserved ejection fraction (PH-HFpEF). Results of Tenax Therapeutics' Phase II HELP study of levosimendan in patients with HFpEF demonstrated that IV levosimendan (TNX-103) produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that is the basis of LEVEL, the Phase III investigation of Tenax Therapeutics' potential groundbreaking therapy. To date, no other drug therapy has demonstrated improved exercise tolerance in patients with PH associated with HFpEF, "a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development. Currently, the drug is in Phase III stage of its development for the treatment of Pulmonary Hypertension.

• TX000045: Tectonic Therapeutic

TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. Currently, the drug is in Phase II stage of its development for the treatment of Pulmonary Hypertension.

• LAM-001: OrphAI Therapeutics

LAM-001 is a proprietary dry powder inhaled formulation of sirolimus, also known as rapamycin. LAM-001 is designed to deliver therapeutic doses of rapamycin directly to the lungs without the systemic exposures and concomitant toxicity seen with oral dosing, thus leading to a potentially safer and more acceptable treatment. This safety profile is supported by data from both animal and early human clinical trials. OrphAI Therapeutics has initiated clinical studies of LAM-001 in the rare lung diseases Pulmonary Hypertension (PH). Currently, the drug is in Phase II stage of its development for the treatment of Pulmonary Hypertension.

• L608 Liposomal inhalation solution: Pharmosa Biopharm Inc.

The L608 formulation is designed to encapsulate prostacyclin drugs in liposomes, providing localized and sustained release characteristics. It also reduces the frequency of daily dosing and allows for dosage adjustments based on the disease progression, significantly improving patients' quality of life. The L608 formulation is specifically engineered to encapsulate prostacyclin drugs within liposomes, enhancing their therapeutic effectiveness by offering localized and sustained drug release. This innovative delivery system significantly reduces the frequency of daily dosing, improving patient compliance and convenience. Additionally, it allows for more precise dosage adjustments based on the progression of the disease, ensuring a tailored treatment approach that adapts to individual patient needs. By providing a controlled release of the active drug, L608 aims to maintain steady therapeutic levels over extended periods, thereby optimizing treatment outcomes. The mechanism of action (MOA) of the L608 formulation involves the activation of epoprostenol receptor agonists, which play a crucial role in promoting vasodilation, inhibiting platelet aggregation, and modulating inflammatory responses. Currently, the drug is in Phase I stage of its development for the treatment of Pulmonary Hypertension.

Pulmonary Hypertension: Therapeutic Assessment

This segment of the report provides insights about the different Pulmonary Hypertension drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Pulmonary Hypertension
• There are approx. 45+ key companies which are developing the therapies for Pulmonary Hypertension. The companies which have their Pulmonary Hypertension drug candidates in the most advanced stage, i.e. Phase II include, GB002, Inc.
• Phases

DelveInsight's report covers around 50+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Pulmonary Hypertension pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Pulmonary Hypertension: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Pulmonary Hypertension therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Pulmonary Hypertension drugs.

Pulmonary Hypertension Report Insights

• Pulmonary Hypertension Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Pulmonary Hypertension Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Pulmonary Hypertension drugs?
• How many Pulmonary Hypertension drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Pulmonary Hypertension?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Pulmonary Hypertension therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Pulmonary Hypertension and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• GB002, Inc.
• Tenax Therapeutics, Inc.
• Tectonic Therapeutic
• OrphAI Therapeutics
• Pharmosa Biopharm Inc.
• United Therapeutics
• Pfizer
• Attgeno AB
• Cumberland Pharmaceuticals
• Pulmovant, Inc.
• Guangzhou Magpie Pharmaceuticals Co., Ltd.
• Foresee Pharmaceuticals Co., Ltd.
• Novartis Pharmaceuticals
• ABLi Therapeutics, Inc.
• 35Pharma Inc
• Beijing Continent Pharmaceutical Co, Ltd.
• Keros Therapeutics, Inc.
• Bayer
• AstraZeneca
• Apollo Therapeutics Ltd

Key Products

• Seralutinib
• TNX-103
• TX000045
• LAM-001
• L608 Liposomal inhalation solution
• Ralinepag
• PF-07868489
• PDNO
• Oral Ifetroban
• Mosliciguat
• MN-08
• Mirivadelgat
• LTP
• IkT-001Pro
• HS135
• F230 tablets
• KER-012
• BAY2701250 IV
• AZD3427
• APL-9796