Critical limb ischemia (CLI), also known as chronic limb-threatening ischemia (CLTI), is the most severe clinical form of Peripheral Artery Disease (PAD), characterized by significantly reduced blood flow to the extremities, leading to pain, ulcers, or risk of amputation. According to Tran Minh Bao Luan et al., 2024, CLTI affects approximately 11% of PAD patients. Current therapies include endovascular interventions, surgical revascularization, and emerging gene- and cell-based treatments. According to the critical limb ischemia pipeline analysis by Expert Market Research, the market is witnessing a growing focus on innovative therapies, driven by increasing prevalence, aging populations, and rising diabetes rates, with significant growth expected in the coming years.
Major companies involved in the critical limb ischemia pipeline analysis include BioGenCell Ltd., MultiGene Vascular Systems Ltd., and others.
Leading drugs currently in the pipeline include TP03HN106, BGC101, [89Zr]Zr-DFO-APAC, and others.
The pipeline is poised for growth, driven by increasing late-stage clinical trials, novel therapeutic approaches targeting vascular regeneration, and rising prevalence of peripheral artery disease globally.
The Critical Limb Ischemia Pipeline Analysis Report by Expert Market Research gives comprehensive insights into critical limb ischemia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for critical limb ischemia. The critical limb ischemia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The critical limb ischemia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with critical limb ischemia treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to critical limb ischemia.
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Critical limb ischemia (CLI) is a severe vascular condition resulting from significant arterial obstruction, causing markedly reduced blood flow to the extremities. It typically arises from advanced peripheral artery disease, atherosclerosis, or diabetes-related vascular damage, leading to rest pain, non-healing wounds, ulcers, and, in severe cases, gangrene. CLI requires timely medical intervention as spontaneous recovery is unlikely.
Critical limb ischemia treatments include revascularization procedures such as angioplasty or bypass surgery, pharmacological therapy to improve blood flow, and emerging regenerative approaches like stem cell therapy for patients unsuitable for conventional interventions. In the pipeline, stem cell therapy is being investigated to stimulate angiogenesis and tissue repair in ischemic limbs where traditional revascularization has failed, offering potential regenerative treatment options.
According to Tran Minh Bao Luan et al., 2024, peripheral artery disease of the lower extremities affects over 230 million adults worldwide, with chronic limb-threatening ischemia accounting for approximately 11% of cases. As per Anahita Dua et al., 2025, patients with no-option CLTI exhibit high rates of major amputation and mortality, with only 37% achieving amputation-free survival at one year, underscoring the urgent need for innovative therapeutic interventions.
This section of the report covers the analysis of critical limb ischemia drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The critical limb ischemia pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase I and II, at 25% each, covers a major share of the total critical limb ischemia clinical trials. It is followed by phase IV at 20%, early phase I at 15%, and phase III at 15%. The strong presence of advanced and early-stage candidates highlights robust development activity, which can drive innovation, expand treatment options, and positively impact treatment pipeline.
The drug molecule categories covered under the critical limb ischemia pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and proteins. The critical limb ischemia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for critical limb ischemia. Cell-based therapies are emerging as innovative treatment options in the critical limb ischemia drug pipeline. For instance, allogeneic adipose tissue-derived mesenchymal stem cell clusters (ADMSCCs) are under clinical investigation for patient’s ineligible for conventional revascularization. ADMSCCs are administered intramuscularly, promoting angiogenesis, reducing ischemic pain, and improving pain-free walking distance, thereby offering a potential alternative for patients with severe peripheral arterial disease.
The EMR report for the critical limb ischemia pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed critical limb ischemia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in critical limb ischemia clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for critical limb ischemia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of critical limb ischemia drug candidates.
BGC101 is an autologous cell therapy developed by BioGenCell Ltd., designed to treat critical limb ischemia (CLI) in patients with peripheral arterial disease who have exhausted standard pharmacological or revascularization options. This Phase 1/2 study is examining the feasibility, safety, and efficacy of BGC101, a personalized cell preparation enriched with endothelial progenitor cells and multipotent hematopoietic stem/progenitor cells. The therapy, derived from the patient’s own blood in a single day, is delivered via intramuscular injection to restore blood flow and promote tissue regeneration.
TP03HN106 is an investigational drug being sponsored by Talengen Institute of Life Sciences, Shenzhen, P.R. China, targeting critical limb ischemia (CLI), the most severe stage of peripheral arterial disease. This Phase 2 study is examining the safety, tolerability, and efficacy of multiple intravenous administrations of TP03HN106 in promoting thrombolysis, reducing resting pain, ulcers, and gangrene, and improving patients’ quality of life. The trial is likely to enroll around 15 participants and aims to provide critical therapeutic insights.
[89Zr]Zr-DFO-APAC, sponsored by Aplagon Oy, is a novel radiolabeled antiplatelet anticoagulant designed for patients with peripheral arterial occlusive disease (PAOD) and critical limb ischemia (CLI). This early Phase 1 study is evaluating the safety, tolerability, pharmacokinetics, and biodistribution of the drug. The trial is examining how [89Zr]Zr-DFO-APAC binds to arteries and vascular lesions, its retention time, and internal radiation dosimetry, using PET/CT imaging at multiple time points post-administration.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Critical Limb Ischemia Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for critical limb ischemia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into critical limb ischemia collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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