Major Pharma Phase III Clinical Trial Failures in 2025: A Comprehensive Overview
AstraZeneca
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Johnson & Johnson
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On the journey of biopharmaceutical research and development, every new drug moving from the laboratory to clinical application must undergo numerous tests. Phase III clinical trials, as the critical gateway to the market, are particularly fraught with uncertainties. In 2025, several international and Chinese pharmaceutical companies reported failures in their Phase III R&D projects.
1. AstraZeneca: Monoclonal AntibodyAnselamimab
AnselamimabIt is an investigational, potentially first-in-class anti-amyloid fibril monoclonal antibody designed to improve organ function by reducing or clearing amyloid deposits in the tissues and organs of patients with AL amyloidosis.
In a pre-specified subgroup of patients, compared with placebo,AnselamimabShowed in terms of all-cause mortality time and cardiovascular hospitalization frequencySignificant Clinical Improvement。
2. Novartis:IL-17A Monoclonal Antibody Cosentyx
Early July,Novartis announces failure of Phase III study of IL-17A monoclonal antibody Cosentyx (secukinumab) in adult patients with giant cell arteritis (GCA).
Cosentyx is the world's first IL-17A antibody, directly inhibiting interleukin-17A (IL-17A), a cytokine that plays a key role in the inflammatory process of various immune-mediated inflammatory diseases. Since its launch in 2015, it has been approved in more than 100 countries worldwide for the treatment of multiple immune-mediated inflammatory diseases, such as moderate to severe plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.
Phase III clinical study shows: Compared with placebo, Cosentyx did not demonstrate statistically significant improvement in sustained remission at week 52. (Further reading: Novartis: $6 billion key drug fails in Phase III study)
3. Johnson & Johnson:Ocular Gene Therapy Bota-Vec
Early May,Johnson & Johnson Announces Its Gene Therapy for Eye Diseasesbotaretigene sparoparvovec(bota-vec) inPhase 3 clinical trial did not meet the primary endpoint. This phase III trial...95 patients were recruitedAmong them, 58 patients received a single low-dose or high-dose treatment of bota-vec. The trial failed to meet the primary endpoint of improving visual navigation ability but showed improvements in several secondary endpoints of the trial.
4、BeiGene:TIGIT Antibody Ociperlimab
In April, BeiGene's TIGIT antibody Ociperlimab (BGB-A1217) also came to a halt in the exploration of lung cancer treatment. Based on the futility analysis by the Independent Data Monitoring Committee, the ongoing Phase 3 clinical trial AdvanTIG-302 is unlikely to reach the primary endpoint of overall survival. This decision rendered approximately 2.1 billion yuan of BeiGene's R&D investment in vain.
As a humanized IgG1 variant monoclonal antibody targeting the TIGIT pathway, Ociperlimab was highly anticipated by BeiGene in combination with the PD-1 inhibitor Tislelizumab for the treatment of non-small cell lung cancer (NSCLC). However, reality has brutally shattered those hopes.
5、Roche:Ocrelizumab
April,Roche Announces Phase III MUSETTE Study of High-Dose Ocrelizumab for Relapsing Multiple Sclerosis (RMS) Did Not Meet Primary Endpoint. The Phase III MUSETTE study showed that 1200mg or 1800mg high doses of ocrelizumab were less effective than the approved 600mg dose in delaying disability progression in RMS patients. Despite good safety profiles in the high-dose groups and no new safety signals, the failure to meet key efficacy endpoints marks this high-dose exploration as unsuccessful.
Ocrelizumab is a humanized monoclonal antibody targeting CD20-positive B cells, co-developed by Roche and Biogen. These B cells are a specific type of immune cell considered to be a key factor in causing damage to myelin and neuronal axons. In March 2017,Ocrelizumab (Trade name:Ocrevus) was approved for the first time in the United States,For the treatment of patients with relapsing or primary progressive multiple sclerosis (MS). March 2025,Ocrelizumab (Trade name:RoclatanApproved for marketing in China.
Conclusion
These failures in Phase III clinical trials are a true reflection of the "nine deaths and one life" nature of biopharmaceutical R&D, while also accumulating valuable experience for the industry. They remind pharmaceutical companies to be more rigorous and prudent in target selection, clinical trial design, dose exploration, and other aspects. Although the failures are regrettable, every exploration deepens the understanding of disease mechanisms, promotes the optimization of R&D concepts, and drives the upgrading of technology platforms.
Reference: Public Information
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