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Pulmonary Hypertension Pipeline, Clinical Trial, and NDA Approval | 80+ Companies and 80+ Pipeline Therapies

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Pulmonary Hypertension Pipeline, Clinical Trial, and NDA Approval | 80+ Companies and 80+ Pipeline Therapies

January 17
17:00 2023
Pulmonary Hypertension Pipeline, Clinical Trial, and NDA Approval  | 80+ Companies and 80+ Pipeline Therapies

DelveInsight’s, “Pulmonary Hypertension Pipeline Insight 2023,” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in the Pulmonary Hypertension pipeline landscape. It covers the Pulmonary Hypertension pipeline drug profiles, including Pulmonary Hypertension clinical trials and nonclinical stage products. It also covers the Pulmonary Hypertension therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Key takeaways from the Pulmonary Hypertension Pipeline Insight Report

  • DelveInsight’s pulmonary hypertension pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for pulmonary hypertension treatment.
  • Key pulmonary hypertension companies such as Reata Pharmaceuticals, Pharmosa BioPharm, United Therapeutics Corporation, Acceleron Pharma, Bellerophon Therapeutics, Northern Therapeutics, Merck Sharp & Dohme Corp., Apeiron Biologics, Abraxis Bioscience, Bayer, Novartis, Aerovate Therapeutics, Cereno Scientific AB, Gossamer Bio, Altavant Sciences GmbH, Gmax Biopharm LLC., Respira Therapeutics, Resverlogix Corp, Aerami Therapeutics, Vigonvita Life Sciences, Ribomic, Corsair Pharma, Centessa Pharmaceuticals, Biozeus, Topadur Pharma, Galectin Therapeutics, PulmoSIM Therapeutics, Keros Therapeutics, Sulfateq BV, LTT Bio-Pharma, AI Therapeutics, Reviva Pharmaceuticals, Sichuan Baili Pharmaceutical, ATXA Therapeutics, Camurus, Celon Pharma, Attgeno, Bial, PhaseBio Pharmaceuticals, Vascular Biosciences, APAXEN, Tenax Therapeutics, Claritas Pharmaceuticals, Halo Biosciences, Aqualung Therapeutics, and others are evaluating novel pulmonary hypertension drugs candidate to improve the treatment landscape.
  • Promising pulmonary hypertension pipeline therapies in various stages of development 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 Hypertension Companies and academics that are working to assess challenges and seek opportunities that could influence Pulmonary Hypertension R&D. The Pulmonary Hypertension pipeline therapies under development are focused on novel approaches to treat/improve the disease condition.

 

Recent Developmental Activities in the Pulmonary 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.
  • In July 2021, PulmoSIM Therapeutics announced that it had entered into a strategic partnership with the investigators from National Jewish Health and Brown University for the clinical development of PT001, a drug that targets multiple responsible pathways in PAH to provide curative treatment. The Food and Drug Administration (FDA) had granted orphan drug designation for PT001 for treating PAH.

 

Discover the recent advances in pulmonary hypertension treatment drugs @ Pulmonary Hypertension Pipeline Outlook

 

Pulmonary Hypertension Overview

Pulmonary hypertension (PH), is a complex and often misunderstood disease. The term PH means high blood pressure in the lungs. In “regular” hypertension (also known as high blood pressure or “systemic hypertension) the pressure in the arteries throughout the body is higher than it should be. This can be measured with a blood pressure cuff. In PH, the blood vessels specifically in the lungs are affected. They can become stiff, damaged or narrow, and the right side of the heart must work harder to pump blood through. Each form of PH is different, so it is important for newly-diagnosed patients to find a PH specialist who can accurately find what is causing their PH and develop a treatment plan that is right for that specific type of PH as soon as possible.

 

Pulmonary Hypertension Emerging Drugs

 

 Ralinepag: Arena Pharmaceuticals/United Therapeutics

Ralinepag (APD811) is a next-generation, oral, selective potent, once-daily IP receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag’s potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life, support its application as a potentially best-in-class agent for the treatment of PAH. Ralinepag is an investigational compound that is not approved for any use in any country. 

Sotatercept: Acceleron Pharma

Sotatercept is an investigational reverse-remodeling agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance signaling in the BMP pathway, which is a key molecular driver of PAH. In preclinical studies, sotatercept was shown to reverse the vascular remodeling that is a hallmark of PAH. Sotatercept is an investigational therapy that is not approved for any use in any country. Sotatercept is part of a licensing agreement with Bristol Myers Squibb. 

Zamicastat: Bial – Portela C S.A.

Zamicastat is a reversible dopamine β-hydroxylase (DβH) inhibitor that modulates sympathetic drive by preventing the conversion of dopamine to norepinephrine (NE) in sympathetically innervated tissues. Sympathetic nervous system (SNS) activation contributes to clinical deterioration in pulmonary arterial hypertension. It can cross the blood-brain barrier (BBB) to cause central as well as peripheral effects. Zamicastat is also a concentration-dependent dual P-gp and BCRP inhibitor with IC50 values of 73.8 μM and 17.0 μM, respectively. Zamicastat tends to reduce high blood pressure. 

Tocilizumab: Roche

Tocilizumab is a drug which blocks the action of Interleukin-6 and blocking Interleukin-6 has been shown to be effective in animal models of PAH. Tocilizumab was demonstrated to be safe and effective in trials in other diseases associated with PAH, such as rheumatoid arthritis. It is an IL6 receptor–blocking antibody that is currently approved for the treatment of rheumatoid arthritis. It has a side‐effect profile that includes increased risk of infection, elevated levels of total cholesterol and low‐density lipoproteins, liver function abnormalities, and gastrointestinal side effects. 

AER-901: Aerami Therapeutics

AER-901 has been developed as a nebulized formulation to improve drug uptake and dosing consistency and to avoid or reduce commonly seen issues related to powdered forms for inhalation including cough, which would be problematic in this group of patients who suffer severe shortness of breath. AER-901 is designed to deliver consistent, therapeutically effective, and well tolerated levels of imatinib through once-a-day inhalation via the Fox device, licensed from Vectura Group plc, which is both 510k cleared and CE marked. The Company is currently investigating AER-901 in healthy adult volunteers in an ongoing phase I trial. 

ABI-009: Aadi Biosciences

Aadi’s lead product ABI-009 (sirolimus albumin-bound nanoparticles for injectable suspension) is an mTOR inhibitor complexed with human albumin that has significantly higher tumor accumulation and improved efficacy over other mTOR inhibitors in preclinical models. mTOR as a therapeutic target is well recognized in oncology, however Aadi aims to develop the full potential of albumin-bound sirolimus in therapeutic areas and diseases that are driven by mTOR activation and where the mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety or effective targeting to the disease site. It is currently being investigated in Phase I stage of development for the treatment of Pulmonary Arterial Hypertension.

 

Find out more about pulmonary hypertension drugs in the report @ Pulmonary Hypertension Treatment Landscape

 

Pulmonary Hypertension Therapeutic Assessment

There are approx. 80+ key companies which are developing the therapies for Pulmonary Hypertension. The Pulmonary Hypertension Companies which have their Pulmonary Hypertension drug candidates in the most advanced stage, i.e. phase II include, Akaza Bioscience.

 

Pulmonary Hypertension Therapeutics Segmentation

The pulmonary hypertension pipeline report proffers an integral view of the pulmonary hypertension emerging novel therapies segmented by stage, product type, molecule type, Mechanism of action, and route of administration.

 

Learn more about the novel and emerging pulmonary hypertension pipeline therapies @ Pulmonary Hypertension Ongoing Clinical Trials

 

Scope of the Pulmonary Hypertension Pipeline Report

  • Coverage- Global
  • Pulmonary Hypertension Companies- Reata Pharmaceuticals, Pharmosa BioPharm, United Therapeutics Corporation, Acceleron Pharma, Bellerophon Therapeutics, Northern Therapeutics, Merck Sharp & Dohme Corp., Apeiron Biologics, Abraxis Bioscience, Bayer, Novartis, Aerovate Therapeutics, Cereno Scientific AB, Gossamer Bio, Altavant Sciences GmbH, Gmax Biopharm LLC., Respira Therapeutics, Resverlogix Corp, Aerami Therapeutics, Vigonvita Life Sciences, Ribomic, Corsair Pharma, Centessa Pharmaceuticals, Biozeus, Topadur Pharma, Galectin Therapeutics, PulmoSIM Therapeutics, Keros Therapeutics, Sulfateq BV, LTT Bio-Pharma, AI Therapeutics, Reviva Pharmaceuticals, Sichuan Baili Pharmaceutical, ATXA Therapeutics, Camurus, Celon Pharma, Attgeno, Bial, PhaseBio Pharmaceuticals, Vascular Biosciences, APAXEN, Tenax Therapeutics, Claritas Pharmaceuticals, Halo Biosciences, Aqualung Therapeutics, and others.
  • Pulmonary 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 Hypertension Segmentation: Phases, Molecule Type, Mechanism of Action, Product Type

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Pulmonary Hypertension: Overview
  4. Pulmonary Hypertension Pipeline Therapeutics
  5. Pulmonary Hypertension Therapeutic Assessment
  6. Pulmonary Hypertension – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Ralinepag: United Therapeutics Corporation
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. RT234: Respira Therapeutics
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. AER-901: Aerami Therapeutics
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. TOP-V122: Topadur
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Pulmonary Hypertension Key Companies
  21. Pulmonary Hypertension Key Products
  22. Pulmonary Hypertension- Unmet Needs
  23. Pulmonary Hypertension- Market Drivers and Barriers
  24. Pulmonary Hypertension- Future Perspectives and Conclusion
  25. Pulmonary Hypertension Analyst Views
  26. Pulmonary Hypertension Key Companies
  27. Appendix

 

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?

 

Dive deep into rich insights for drugs for pulmonary hypertension treatment, visit @ Pulmonary Hypertension Key Companies and Therapies

 

About Us

DelveInsight is a Business Consulting and Market research company, providing expert business solutions for the healthcare domain and offering quintessential advisory services in the areas of R&D, Strategy Formulation, Operations, Competitive Intelligence, Competitive Landscaping, and Mergers & Acquisitions.

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