With brain metastases increasingly prevalent worldwide and contributing to comorbid conditions such as diabetes, cardiovascular disease, and certain cancers, the demand for safer and more effective therapies continues to rise. According to DelveInsight, the brain metastases pipeline features 40+ pharmaceutical and biotech companies actively developing over 45 therapeutic candidates. These therapies are at various stages of clinical and preclinical development, reflecting significant innovation and dedication to tackling one of today’s most critical public health challenges.
DelveInsight’s “Brain Metastases Pipeline Insight 2025” report delivers a comprehensive and strategic analysis of the current R&D landscape, covering clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. It serves as an essential resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving brain metastases therapeutics market and the innovations shaping its future.
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During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:
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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).
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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.
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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).
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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.
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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.
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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.
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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.
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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.
Key Takeaways from the Brain Metastases Pipeline Report
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DelveInsight’s Brain Metastases pipeline report highlights a dynamic landscape with 40+ active companies developing over 45 pipeline therapies for the treatment of brain metastases.
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In July 2021, the FDA issued final guidance titled “Evaluating Cancer Drugs in Patients with Central Nervous System Metastases”, offering recommendations for designing clinical trials that include patients with CNS metastases. The guidance aims to enhance the evaluation of therapeutic benefits and risks in this patient population.
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Key companies involved in advancing brain metastases therapies include HUYA Bioscience, Kazia Therapeutics, BioMimetix, EpicentRx, Inc., Angiochem, Medolution Ltd., Betta Pharmaceuticals Co., Ltd., Merck Sharp & Dohme LLC, Bristol-Myers Squibb, 2-BBB Medicines, DEKK-TEC, Inc., Nascent Biotech, Quadriga Biosciences, Inc., Jubilant Therapeutics, Denali Therapeutics Inc, NUVATION BIO, Novocure GmbH, Affinia Therapeutics, Specialised Therapeutics, Precirix, Ashvattha Therapeutics, Cereius, Allarity Therapeutics, TYK Medicine, Surgimab, ORIC Pharmaceuticals, SonALAsense, Nerviano Medical Sciences, Lin Bioscience, Inc., Zai Lab, Lantern Pharma, ABM Therapeutics, Carthera, among others, all actively evaluating new drug candidates to advance the treatment landscape.
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Promising pipeline therapies under development include HBI-8000, Paxalisib, BMX-001, RRx-001, ANG1005, JBI 2174, SCR 6852, Keynatinib, ATV HER2, Icotinib, Pembrolizumab, Pritumumab, Nivolumab, Palbociclib, DM-CHOC-PEN, MW151, Elacestrant, Atezolizumab, Trastuzumab Deruxtecan, AMG 510, 2B3-101, CER-101, 2X-111, Encorafenib, TY-9591, SGM-101, Binimetinib, ORIC-114, SONALA-001, NVL-520, Entrectinib, HKI-272, LBS-002, D6-B483, LP-184, and many others.
Brain Metastases Overview:
Brain metastases are among the most common complications of cancer and constitute the most frequently occurring type of brain tumor. Studies indicate that 10% to 26% of cancer patients who ultimately die from their disease will develop brain metastases. While traditional treatments rarely provide a cure once cancer spreads to the brain, many patients can still experience prolonged survival and symptomatic relief with minimal adverse effects. As life expectancy for these patients improves, preserving neurocognitive function and quality of life has become a central focus of therapy.
In the United States, these secondary brain tumors are the most frequently diagnosed intracranial neoplasms, with an estimated 98,000 to 170,000 new cases annually. Several factors are driving this increase. Improvements in systemic cancer therapies, particularly immunotherapies, have extended survival for patients with metastatic disease, thereby increasing the chances of brain involvement. Furthermore, the widespread use of high-resolution MRI has enhanced early detection of even small, asymptomatic brain lesions.
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Brain Metastases Pipeline Analysis
The Brain Metastases pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Brain Metastases Market.
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Categorizes Brain Metastases therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Brain Metastases drugs under development based on:
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Stage of development
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Brain Metastases Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Brain Metastases Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Brain Metastases Licensing agreements
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Funding and investment activities supporting future Brain Metastases market advancement.
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Unlock key insights into emerging Brain Metastases therapies and market strategies here: https://www.delveinsight.com/report-store/brain-metastases-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Brain Metastases Emerging Drugs
ANG1005 – Angiochem
Azeliragon is an oral RAGE inhibitor that disrupts cancer-promoting pathways within the tumor microenvironment. Originally developed for Alzheimer’s disease, it is now being explored as a potential treatment for brain metastases and other cancers. The therapy is currently in Phase I/II clinical trials.
Azeliragon – Cantex Pharmaceuticals
Azeliragon is an oral RAGE inhibitor that interferes with cancer-promoting signals in the tumor microenvironment. Initially developed for Alzheimer’s disease, it is now being investigated for its potential in treating brain metastases and other cancers. The drug is currently in Phase I/II trials.
AZD3759 (Zorifertinib) – Alpha Biopharma
Zorifertinib is a next-generation EGFR tyrosine kinase inhibitor developed to effectively reach the brain and cerebrospinal fluid. It is designed to treat EGFR-mutant cancers with brain involvement and recently concluded a Phase II/III trial in July 2022 for brain metastases.
Brain Metastases Pipeline Therapeutic Assessment
Brain Metastases Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Brain Metastases By Stage
• 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
Brain Metastases Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Brain Metastases Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Download sample pages to get an in-depth assessment of the emerging Brain Metastases therapies and key Brain Metastases companies
Table of Contents
1. Report Introduction
2. Executive Summary
3. Brain Metastases Current Treatment Patterns
40. Brain Metastases – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
45. Brain Metastases Late-Stage Products (Phase-III)
7. Brain Metastases Mid-Stage Products (Phase-II)
40. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
45. Inactive Products
11. Dormant Products
12. Brain Metastases Discontinued Products
13. Brain Metastases Product Profiles
140. Brain Metastases Key Companies
15. Brain Metastases Key Products
145. Dormant and Discontinued Products
17. Brain Metastases Unmet Needs
140. Brain Metastases Future Perspectives
19. Brain Metastases Analyst Review
20. Appendix
21. Report Methodology
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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