Pulmonary Arterial Hypertension Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

March 12 14:56 2025
Pulmonary Arterial Hypertension Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Pulmonary Arterial Hypertension Pipeline Insight” report provides comprehensive insights about 55+ companies and 55+ pipeline drugs in Pulmonary Arterial Hypertension pipeline landscape. It covers the Pulmonary Arterial Hypertension pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Pulmonary Arterial Hypertension therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Pulmonary Arterial Hypertension Pipeline Report

  • In March 2025:- United Therapeutics conducted a study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).
  • In March 2025:- Actelion announced a study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
  • In March 2025: Merck Sharp & Dohme LLC announced a study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to
  • DelveInsight’s Pulmonary Arterial Hypertension Pipeline analysis depicts a robust space with 55+ active players working to develop 55+ pipeline treatment therapies.
  • The leading Pulmonary Arterial Hypertension Companies such as Merck Sharp & Dohme, Acceleron Pharma, Liquidia Technologies, Gossamer Bio, Resverlogix, PhaseBio Pharmaceuticals, Pharmosa BioPharm, Complexa, Gmax Biopharm Australia, Mezzion, Radikal Therapeutics, Galectin Therapeutics, Altavant Sciences, Ribomic and others.
  • Promising Pulmonary Arterial Hypertension Therapies such as TPN171H, Tadalafil, Treprostinil Palmitil, Satralizumab (Genetical Recombination), PF-07868489, Sotatercept and others.

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Pulmonary Arterial Hypertension Emerging Drugs Profile

  • Sotatercept: Acceleron Pharma

Sotatercept is a first-in-class therapeutic fusion protein comprised of the extracellular domain of human activin receptor type IIA, fused to the Fc domain of human immunoglobulin G1 (IgG1). It provides balance of the growth-promoting activin growth differentiation factor pathway, and the growth-inhibiting BMP pathway by serving as a ligand trap for the TGF-β superfamily. The United States Food and Drug Administration (FDA) has granted Orphan Drug designation and Breakthrough Therapy designation to sotatercept for the treatment of PAH; the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of PAH. Sotatercept is in Phase III clinical trial for the treatment of PAH.

  • LIQ861: Liquidia Technologies

LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using the Company’s novel PRINT technology and engineered with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler. Liquidia resubmits New Drug Application for LIQ861 under the 505(b)(2) regulatory pathway for the treatment of pulmonary arterial hypertension (PAH).

The Pulmonary Arterial Hypertension Pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Pulmonary Arterial Hypertension with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Pulmonary Arterial Hypertension Treatment.
  • Pulmonary Arterial Hypertension Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Pulmonary Arterial Hypertension Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Pulmonary Arterial Hypertension market

Stay informed about the Pulmonary Arterial Hypertension pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Pulmonary Arterial Hypertension Unmet Needs

Pulmonary Arterial Hypertension Companies

Merck Sharp & Dohme, Acceleron Pharma, Liquidia Technologies, Gossamer Bio, Resverlogix, PhaseBio Pharmaceuticals, Pharmosa BioPharm, Complexa, Gmax Biopharm Australia, Mezzion, Radikal Therapeutics, Galectin Therapeutics, Altavant Sciences, Ribomic and others.

Pulmonary Arterial 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
  • Parenteral
  • Intravitreal
  • Subretinal
  • Topical
  • Molecule Type

Pulmonary Arterial Hypertension Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy
  • Product Type

Transform your understanding of the Pulmonary Arterial Hypertension Pipeline! See the latest progress in drug development and clinical research @ Pulmonary Arterial Hypertension Market Drivers and Barriers, and Future Perspectives

Scope of the Pulmonary Arterial Hypertension Pipeline Report

  • Coverage- Global
  • Pulmonary Arterial Hypertension Companies- Merck Sharp & Dohme, Acceleron Pharma, Liquidia Technologies, Gossamer Bio, Resverlogix, PhaseBio Pharmaceuticals, Pharmosa BioPharm, Complexa, Gmax Biopharm Australia, Mezzion, Radikal Therapeutics, Galectin Therapeutics, Altavant Sciences, Ribomic and others.
  • Pulmonary Arterial Hypertension Therapies- TPN171H, Tadalafil, Treprostinil Palmitil, Satralizumab (Genetical Recombination), PF-07868489, Sotatercept and others.
  • Pulmonary Arterial Hypertension Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Pulmonary Arterial Hypertension Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

  1. Introduction
  2. Executive Summary
  3. Pulmonary Arterial Hypertension: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Pulmonary Arterial Hypertension – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Sotatercept: Acceleron Pharma
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. GB-002: Gossamer Bio
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. Apabetalone: Resverlogix
  15. Drug profiles in the detailed report…..
  16. Preclinical/Discovery Stage Products
  17. R107: Radikal Therapeutics
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Pulmonary Arterial Hypertension Key Companies
  21. Pulmonary Arterial Hypertension Key Products
  22. Pulmonary Arterial Hypertension- Unmet Needs
  23. Pulmonary Arterial Hypertension- Market Drivers and Barriers
  24. Pulmonary Arterial Hypertension- Future Perspectives and Conclusion
  25. Pulmonary Arterial Hypertension Analyst Views
  26. Appendix

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