Sanofi Triggers $600M Milestone with Initiation of Four Phase III Trials for TL1A Antibody Duvakitug

▎Armstrong

On September 22, 2025, Sanofi registered four Phase III clinical trials for the TL1A antibody Duvakitug on the Clinicaltrials.gov website, for the treatment of ulcerative colitis (UC) and Crohn's disease (CD), respectively.

In October 2023, Sanofi introduced Teva's TL1A antibody. According to the agreement, Teva is responsible for commercialization in Europe, Israel, and other specific countries, while Sanofi is responsible for commercialization in North America, Japan, other Asian countries, and other global countries. Sanofi paid an upfront payment of $500 million and milestone payments of $1 billion.

Phase III Clinical Trial Initiated: Sanofi to Pay $600 Million Milestone, Additional $400 Million Upon Approval. The initiation of Phase III indicates that Sanofi will pay the $600 million milestone amount.

TEV574 is a differentiated TL1A antibody that blocks the DR3 receptor but does not block the DcR3 decoy receptor.

Compared with competing products, TEV574 has better selectivity and stronger biological activity.

Summary

TL1A is the most fiercely contested new target in the IBD field. Roche invested over $7 billion to introduce RVT-3101 from Pfizer/Roivant, while Merck acquired Prometheus for $10.8 billion. Sanofi invested $1.5 billion to acquire Teva's TL1A antibody. All three companies have advanced their TL1A antibodies into Phase III clinical trials. The competition for TL1A has entered its second phase, focusing on long-acting antibodies and dual-target therapies. Pfizer and Roche have both developed dual-target therapies, Sanofi has introduced a dual-target therapy from HuaShen ZhiYao, and AbbVie has acquired a long-acting TL1A antibody from MingJi Biotech.