Cachexia Clinical Trials Analysis 2025: Metabolic Modulators, Anabolic Therapies, and Anti-inflammatory Approaches Aim to Restore Mass and Function | DelveInsight

DelveInsight's "Cachexia - Clinical Trials Analysis, 2025" examines a diverse development landscape targeting the complex metabolic, inflammatory, and neurohormonal drivers of cancer- and disease-related wasting. Given cachexia's strong association with poor survival, treatment intolerance, and reduced quality of life, trials increasingly measure both anabolic endpoints (lean body mass, muscle strength) and patient-centered outcomes (physical function, fatigue, appetite).

Late-stage and registration-enabling programs span ghrelin agonists and appetite stimulants, selective androgen receptor modulators (SARMs), myostatin/ActRII pathway inhibitors, and anti-inflammatory or metabolic modulators designed to blunt catabolism. Anabolic agents and myostatin blockers aim to increase muscle mass and strength, while anti-cachexia strategies combining anti-inflammatory effects with metabolic correction seek to improve functional outcomes and treatment tolerance in oncology and chronic disease cohorts. Key trial endpoints emphasize lean mass, 6-minute walk/handgrip tests, symptom scores, and overall survival or treatment continuity.

The clinical pipeline is broad: industry and academic sponsors are running randomized Phase II/III studies across cancer-associated cachexia, COPD, heart failure, and chronic kidney disease. Combination strategies pairing anabolic agents with exercise/nutritional programs are common, reflecting a multimodal treatment philosophy. Leading biotechs and pharma - developing ghrelin receptor agonists, myostatin inhibitors, SARMs, and anti-catabolic biologics - are advancing pivotal trials; upcoming readouts over the next 12-24 months will be pivotal in defining effective, regulatory-ready therapies that can shift cachexia care from supportive to disease-modifying.

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Key Takeaways from the Cachexia Pipeline Report
• DelveInsight's cachexia pipeline analysis depicts a strong space with 27+ active players working to develop 27+ pipeline drugs for cachexia treatment.
• The leading cachexia companies include Tvardi Therapeutics, TMS Co. Ltd, RaQualia Pharma, Pfizer, Pephexia Therapeutics, Oncocross, NGM Biopharmaceuticals, MGC Pharmaceuticals, Keros Therapeutics, Incyte Corporation, ImmunoForge, Immuneering Corporation, Green Cross Wellbeing, GlaxoSmithKline, Faraday Pharmaceuticals, Extend Biosciences, Energenesis Biomedica, Endevica Bio, CNBX Pharmaceuticals, CatalYm, Caelus Health, AVEO Oncology, Artelo Biosciences, Aphios Corporation, AliveGen, AEterna Zentaris, Actimed Therapeutics, AAVogen, and others are evaluating their lead assets to improve the cachexia treatment landscape.
• Key cachexia pipeline therapies in various stages of development include TTI 101, TMS-008, RQ-00433412, PF 06946860, peptide-based pharmacotherapies (research programme), OC514, NGM120, Tetrinol, ligand traps (research programme), Ruxolitinib, PF-1801, Cancer Cachexia (research programme), GCBWB204, GSK2881078, ACM-002, EXT418, EOM613, ENERGI-F704, TCMCB07, Cannabics capsules, CTL-002, CH-0701, AV-380, ART27.13, APH-0802, novel Biotherapeutics (research programme), and others.
• In September 2024, Pfizer Inc. (NYSE: PFE) announced that its Phase II study of ponsegromab, a monoclonal antibody targeting GDF-15, met its primary endpoint, showing a significant change in body weight from baseline in cancer cachexia patients with elevated GDF-15 levels compared to placebo. Cachexia, a life-threatening condition, severely impacts patients' quality of life. The results were presented as a late-breaking Proffered Paper (LBA82) at the 2024 ESMO Congress and published in The New England Journal of Medicine (NEJM).

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Cachexia Overview
Cachexia, or wasting syndrome, is a complex metabolic disorder characterized by the progressive loss of skeletal muscle mass, often with fat loss, and is commonly seen in chronic illnesses such as cancer, HIV/AIDS, COPD, kidney disease, and heart failure. It involves systemic inflammation, anorexia, insulin resistance, and accelerated protein breakdown. Unlike simple starvation, cachexia is driven by disease-related metabolic changes, including tumor-induced disruptions that worsen nutritional status and impair recovery. The condition weakens immunity, reduces tolerance to therapies like chemotherapy, and contributes to physical decline. Hormonal imbalances-such as decreased levels of IGF-1, testosterone, growth hormone, and ghrelin-further promote muscle wasting, making cachexia a significant challenge in the management of chronic and terminal illnesses.

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Cachexia Treatment Analysis: Drug Profile
GCBWB204: Green Cross Wellbeing
GCBWB204 (BST-204) is an innovative drug candidate for cancer cachexia, a condition that causes muscular atrophy and metabolic disturbances in cancer patients. Utilizing GC Wellbeing's proprietary Bio-Transformation Technology, BST204 has been shown to enhance specific saponin components, providing therapeutic benefits in reducing muscle loss, improving exercise capacity, and mitigating inflammation and hematopoietic toxicity associated with cancer cachexia. BST204 has undergone safety testing in non-clinical toxicity studies in Canada and clinical trials in Europe. The drug exhibits multimodal action by inhibiting muscle degradation and inflammatory cytokines while promoting muscle growth. Green Cross Wellbeing holds patent protection for the pharmaceutical composition and manufacturing method of GCBWB204 in South Korea. The company has successfully completed Phase II clinical trials of GCBWB204 in patients with non-small cell lung cancer and digestive cancers in Europe.

AV-380: AVEO Oncology
AVEO's AV-380 is a preclinical, first-in-class, potent humanized inhibitory antibody that targets growth differentiation factor 15 (GDF15), a pro-inflammatory cytokine whose elevated levels are linked to cachexia in cancer patients. This condition, characterized by severe weight loss due to muscle and fat tissue depletion, is accompanied by anemia, inflammation, and immune system suppression. Preclinical data suggest that inhibiting GDF15 shifts the body's metabolism from catabolism to anabolism, which may reverse the symptoms of cachexia. AVEO has regained the rights to the AV-380 program, which is being explored for the treatment of cachexia, a condition affecting approximately 5 million Americans with advanced cancer and other chronic illnesses. The company is planning to initiate preclinical toxicology studies and is considering various development pathways, including filing an Investigational New Drug application with the FDA.

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Cachexia Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

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

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Cachexia Pipeline Report
• Coverage: Global
• Key Cachexia Companies: Tvardi Therapeutics, TMS Co. Ltd, RaQualia Pharma, Pfizer, Pephexia Therapeutics, Oncocross, NGM Biopharmaceuticals, MGC Pharmaceuticals, Keros Therapeutics, Incyte Corporation, ImmunoForge, Immuneering Corporation, Green Cross Wellbeing, GlaxoSmithKline, Faraday Pharmaceuticals, Extend Biosciences, Energenesis Biomedica, Endevica Bio, CNBX Pharmaceuticals, CatalYm, Caelus Health, AVEO Oncology, Artelo Biosciences, Aphios Corporation, AliveGen, AEterna Zentaris, Actimed Therapeutics, AAVogen, and others.
• Key Cachexia Pipeline Therapies: TTI 101, TMS-008, RQ-00433412, PF 06946860, peptide-based pharmacotherapies (research programme), OC514, NGM120, Tetrinol, ligand traps (research programme), Ruxolitinib, PF-1801, Cancer Cachexia (research programme), GCBWB204, GSK2881078, ACM-002, EXT418, EOM613, ENERGI-F704, TCMCB07, Cannabics capsules, CTL-002, CH-0701, AV-380, ART27.13, APH-0802, novel Biotherapeutics (research programme), and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Cachexia Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Cachexia Pipeline Therapeutics
6. Cachexia Pipeline: Late-Stage Products (Phase III)
7. Cachexia Pipeline: Mid-Stage Products (Phase II)
8. Cachexia Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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