Pulmonary Arterial Hypertension Pipeline, Clinical Trials Analysis, FDA Approvals 2023 | Major Companies – Merck Sharp & Dohme, Acceleron Pharma, and others

May 18 03:15 2023
Pulmonary Arterial Hypertension Pipeline, Clinical Trials Analysis, FDA Approvals 2023 | Major Companies - Merck Sharp & Dohme, Acceleron Pharma, and others

DelveInsight’s, “Pulmonary Arterial Hypertension Pipeline Insight 2023” report provides comprehensive insights about 55+ companies and 55+ pipeline drugs in the Pulmonary Arterial Hypertension pipeline landscape. It covers the Pulmonary Arterial Hypertension pipeline drug profiles, including Pulmonary Arterial Hypertension clinical trials 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.

 

Recent Developmental Activities in the Pulmonary Arterial Hypertension Treatment Landscape

 

  • In July 2022, Cereno Scientific announced that the first patient had been enrolled in the Phase II study in pulmonary arterial hypertension (PAH) with drug candidate CS1. Based on the timing of enrollment and several factors mainly related to the activation of clinical sites, the study timeline has been adjusted by about a quarter and top-line results are now estimated for Q1 2023. The number of study sites has been increased to include about 10 clinics across the US with potential for further expansion in order to facilitate meeting the Q1 timeline.

 

  • In June 2022, Gossamer Bio, Inc. announced the publication of key preclinical data supporting the potential of seralutinib for the treatment of pulmonary arterial hypertension (PAH). Inhaled seralutinib was an effective treatment of severe PAH in two animal models, with improved cardiopulmonary hemodynamics, reduction in NT-proBNP, reverse remodeling of pulmonary vascular pathology, and improvement in inflammatory biomarkers. Seralutinib showed greater efficacy compared to imatinib in a preclinical study.

 

  • In June 2022, Keros Therapeutics, Inc. announced results from a preclinical study of RKER-012 on cardiac and pulmonary pathology in an established rodent model of pulmonary arterial hypertension (“PAH”), which were presented at the Pulmonary Hypertension Association International Conference and Scientific Sessions held on June 10 through 12, 2022.

 

  • In June 2022, Attgeno AB announced that it had received approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to start a phase 2 clinical trial of its lead drug candidate Supernitro as a potentially lifesaving treatment for patients with acute pulmonary hypertension after cardiac surgery.

 

  • In May 2022, Aerovate Therapeutics, Inc. presented Phase 1 results at the American Thoracic Society (ATS) International Conference in San Francisco. Aerovate’s data showed that AV-101, a novel inhaled dry powder formulation of imatinib, was generally well-tolerated by healthy adult volunteers with no serious adverse events reported. AV-101 is being developed to address cellular hyperproliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of PAH.

 

  • In May 2022, Altavant Sciences, presented results from a preclinical study comparing rodatristat ethyl as a monotherapy and in combination with the type A endothelin receptor antagonist, ambrisentan, in an animal model of pulmonary arterial hypertension (PAH). Results describing changes in post-hypoxia occlusions as well as mean pulmonary arterial pressure (mPAP) with each treatment regimen were presented in a poster at ATS 2022 held in San Francisco, CA, May 13-18, 2022.

 

  • In April 2022, Respira Therapeutics, announced that the first patient in the United States had been dosed in the multicenter trial of its lead product candidate, RT234-PAH (vardenafil administered as a dry powder inhaled treatment). The VIPAH-PRN 2b trial (Vardenafil Inhaled for Pulmonary Arterial Hypertension – PRN) will consist of two sequential cohorts receiving RT234 as single doses administered via an Axial Oscillating Sphere dry powder inhaler. The study is designed to evaluate the safety and preliminary efficacy of RT234 to acutely improve episodic symptoms and exercise capacity in people being treated for pulmonary arterial hypertension (PAH) with New York Heart Association (NYHA) Functional Class II-III symptoms.

 

  • In March 2022, Resverlogix Corp. announced the publication of an article entitled “BET Protein Inhibition for Pulmonary Arterial Hypertension: A Pilot Clinical Study” in the prestigious American Journal of Respiratory and Critical Care Medicine. The article outlines the positive impact of apabetalone in the investigator-led pulmonary arterial hypertension (PAH) pilot study, APPRoAcH-p.

 

Request a sample and discover the recent breakthroughs happening in the Pulmonary Arterial Hypertension Pipeline Landscape @ Pulmonary Arterial Hypertension Pipeline Outlook

 

Pulmonary Arterial Hypertension Overview

Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening blood vessel disorder. PAH is characterized by a thickening of the pulmonary vasculature, leading to restricted blood flow and elevated blood pressure within the pulmonary vessels. The tests that are commonly performed to diagnose PAH and rule out other diseases are echocardiography, blood tests, pulmonary function tests, X-rays of the chest, lung blood flow scans, electrocardiography (ECG), and the “6-minute walk test”, which measures how far an individual can walk in that time period. Treatment for PAH includes prostaglandins, endothelin receptor antagonists, phosphodiesterase Type 5 inhibitors. Other treatments such as anticoagulants, diuretics, and oxygen may be used to treat PAH as supportive therapies.

 

Key Takeaways from the Pulmonary Arterial Hypertension Pipeline Report

 

  • 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 include 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 Pipeline Therapies include Bardoxolone methyl, L606, Ralinepag, Sotatercept, Inhaled Nitric Oxide, Autologous EPCs transfected with human eNOS, MK-5475, Alunacedase alfa, ABI-009, BAY1237592, LTP001,  AV-101, CS1, GB002, rodatristat ethyl, GMA301, RT234, Apabetalone, AER-901, TPN171H, ,RBM-011, VPD-380,  MGX 292, BZ371, TOP-V122, Belapectin, PT001, KER-012, SUL-150, LT-2004, LAM-001, RP5063, SI-F019, NTP42, CAM2043, CPL409116, PDNO, Zamicastat, PB1046, R-107, H01, ALT-100, and others.

 

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

 

Find out more about the Pulmonary Arterial Hypertension Diagnosis and Treatment of patients @ Pulmonary Arterial Hypertension Ongoing Clinical Trials Analysis

 

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).

 

Pulmonary Arterial Hypertension Therapeutics Assessment

There are approx. 55+ key companies which are developing the therapies for Pulmonary Arterial Hypertension. The companies which have their Pulmonary Arterial Hypertension drug candidates in the most advanced stage, i.e. Preregistration include, Liquidia Technologies.

 

Discover more about the list of Pulmonary Arterial Hypertension FDA-approved drugs @ Pulmonary Arterial Hypertension Treatment Landscape

 

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 Pipeline Therapies- Bardoxolone methyl, L606, Ralinepag, Sotatercept, Inhaled Nitric Oxide, Autologous EPCs transfected with human eNOS, MK-5475, Alunacedase alfa, ABI-009, BAY1237592, LTP001,  AV-101, CS1, GB002, rodatristat ethyl, GMA301, RT234, Apabetalone, AER-901, TPN171H, ,RBM-011, VPD-380,  MGX 292, BZ371, TOP-V122, Belapectin, PT001, KER-012, SUL-150, LT-2004, LAM-001, RP5063, SI-F019, NTP42, CAM2043, CPL409116, PDNO, Zamicastat, PB1046, R-107, H01, ALT-100, and others.
  • Pulmonary Arterial Hypertension Pipeline Segmentation: Product Type, Molecule Type, Route of Administration

 

Dive deep into rich insights for Pulmonary Arterial Hypertension Emerging Therapies and Ongoing Clinical Trials; visit @ Pulmonary Arterial Hypertension Emerging Therapies and Companies

 

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

 

Got Queries? Find out the related information on Pulmonary Arterial Hypertension Mergers and acquisitions, Pulmonary Arterial Hypertension Licensing Activities @ Pulmonary Arterial Hypertension Emerging Drugs, and Recent Trends

 

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