Trispecific Antibodies Clinical Trials, Fast Track Status, Technology Platforms & Market Opportunity Outlook 2025

The trispecific antibody market has emerged as a promising and dynamic field in biopharmaceuticals, driven largely by ongoing advancements in multispecific antibody research. The success of monoclonal and bispecific antibodies has laid the foundation for the development of trispecific antibodies, a next-generation innovation in immunotherapy.

These trispecific antibodies target three distinct antigens, enhancing their therapeutic potential in comparison to their monoclonal and bispecific counterparts. While none of the trispecific antibodies have yet gained approval, several candidates are in advanced stages of development, with some in Phase II/III clinical trials, indicating a potential for approval in the near future.

Report Findings & Highlights:

• First Trispecific Antibody Commercial Approval Expected By 2028
• Currently More Than 50 Trispecific Antibodies Are Under Clinical Trials
• Report Includes Clinical Trials Insight On More Than 50 Trispecific Antibodies By Company, Country, Indication & Phase
• China & USA Dominating Trispecific Antibody Research
• Highest Phase Of Development: Phase II/III
• Insight On Platforms Used For Pioneering Trispecific Antibody By Companies
• Trispecific Antibodies Therapeutic Clinical Tends By Region & Indications
• Insight On 20 Key Companies Developing Trispecific Antibodies

Many companies, both large and small, are now focusing their efforts on the development of trispecific antibodies, often collaborating with other organizations to pool resources and expertise. For instance, in January 2025, AbbVie and Simcere Zaiming entered into an option-to-license agreement for the development of SIM0500, a humanized trispecific antibody targeting GPRC5D, BCMA, and CD3. This antibody is currently undergoing Phase I clinical trials in the US and China for patients with relapsed or refractory multiple myeloma (MM). Under the agreement, Simcere Zaiming stands to receive an upfront payment from AbbVie, in addition to milestone payments and option fees that could total up to US$ 1.055 Billion, depending on the success of the program.

Trispecific antibodies have demonstrated promising preclinical results, often outperforming traditional therapies. A notable example is ISB 2001, a BCMA/CD38/CD3 trispecific antibody developed by Ichnos Glenmark Innovation. When tested against bispecific antibodies like Janssen's Tecvayli and Bristol Myers Squibb's candidate alnuctamab in human cell lines, ISB 2001 showed a 20- to 260-fold stronger cancer-killing potency. Furthermore, ISB 2001 proved superior to Tecvayli in its ability to eliminate tumors from multiple myeloma patients. In animal models, ISB 2001 completely eradicated tumors in all eight mice treated with a low dose, whereas Tecvayli showed limited efficacy, with only a 30.8% tumor growth inhibition. These promising results highlight the enhanced therapeutic potential of trispecific antibodies in comparison to existing therapies.

New clinical trials for trispecific antibodies continue to emerge, further solidifying their promise in cancer treatment and beyond. For instance, in March 2025, CStone Pharmaceuticals announced the successful dosing of the first patient in a global multicenter Phase I clinical trial of CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody. Early reports indicate that no infusion reactions or other adverse events were observed, providing further evidence of the safety profile of these advanced therapeutics. As these trials progress, the market for trispecific antibodies will likely expand, offering new options for patients with cancer and other conditions that have proven resistant to conventional therapies.

Despite the optimistic outlook, there are several challenges facing the development of trispecific antibodies. The complexity of manufacturing and the need for precise targeting of multiple antigens are among the key hurdles. The development of effective and scalable manufacturing processes will be crucial to ensuring the success of trispecific antibody therapies. Additionally, regulatory challenges, particularly in terms of safety and efficacy data, may slow the path to approval for these innovative treatments.

Regardless, the market for trispecific antibodies continues to grow due to factors such as the growing demand for more targeted and effective cancer therapies, as well as advancements in antibody engineering and production technologies. The increasing success of bispecific antibodies, combined with the growing number of clinical trials demonstrating the potential of trispecifics, is likely to drive further investment and interest in this market. As a result, the trispecific antibody market is expected to see significant growth in the coming years, with more collaborations, clinical trials, and potentially, market approvals paving the way for this promising new class of therapeutics.