ADEL has announced an exclusive worldwide license agreement with Sanofi for the rights to develop and commercialize ADEL-Y01, ADEL’s potential first-in-class antibody therapy for Alzheimer's disease. Sanofi is also expected to include related backup compounds in the agreement.

ADEL-Y01 is a humanized monoclonal antibody that selectively targets tau protein acetylated at Lysine-280 (acK280). This process inhibits the aggregation and propagation of toxic tau species—a key driver of Alzheimer's pathology—while preserving the function of normal microtubule-associated tau.¹

Currently, ADEL-Y01 is undergoing a global, first-in-human Phase I clinical trial, as part of an Investigational New Drug application approved by FDA.¹

ADEL spearheaded ADEL-Y01’s entire discovery and preclinical development cycle using its proprietary neural disease research and development platform.¹ Since 2020, ADEL has been co-developing the asset through a joint research and development agreement with Oscotec Inc.

"This strategic partnership with Sanofi, a global leader in healthcare, underscores ADEL's technological strength and highlights the therapeutic promise of ADEL-Y01," said Seung-Yong Yoon, CEO of ADEL, in a press release. "By combining our scientific expertise with the proven development and commercialization capabilities of Sanofi, we hope to accelerate the delivery of this disease-modifying therapy to people living with Alzheimer's around the world."

What are the financial details of the agreement?

Per the terms of the agreement, ADEL grants Sanofi exclusive rights to commercialize and develop ADEL-Y01 globally. The total potential value of the agreement is estimated to be upwards of $1.04 billion.

ADEL will receive a non-refundable upfront payment of $80 million, along with eligibility to achieve additional payments contingent upon specified development and commercial milestones.¹

Additionally, the agreement entitles ADEL to receive tiered royalties on net sales ranging up to double-digit percentages.

“ADEL's innovative approach to targeting tau acetylation offers a promising and differentiated mechanism for addressing the underlying causes of Alzheimer's disease,” Erik Wallstroem, global head of multiple sclerosis, neurology and gene therapy development, Sanofi, said in the press release. “We look forward to advancing ADEL-Y01 through clinical development to provide new hope for patients living with this devastating condition."

Sanofi continues to expand its partnerships with Dren Bio

Along with announcing its exclusive agreement with ADEL, Sanofi announced today that it has entered into a strategic collaboration with Dren Bio for the discovery and development of a next-generation B-cell depleting therapy for the treatment of various autoimmune diseases.²

The new agreement builds on the previously established relationship between the two companies, following Sanofi’s acquisition earlier this year of Dren Bio’s program for deep B-cell depletion, DR-0201.²

For the new agreement, Dren Bio will receive an upfront payment of $100 million with the ability to achieve up to $1.7 billion in development, regulatory, and commercial milestone benchmarks. After selecting a development candidate, Sanofi will take on development, manufacturing, regulatory, and commercialization responsibilities.

As part of the agreement, Dren Bio has the option to enter into a US profit/loss sharing arrangement in which it will co-fund 40% of global developmental costs while receiving US co-promotion rights and a 50% share of US profits and losses.

“Our newly expanded strategic alliance with Dren Bio reflects Sanofi’s deep commitment to developing best-in-class therapies with the potential to achieve remission in patients with immune-mediated diseases,” said Alyssa Johnsen, global therapeutic head, immunology and oncology development, Sanofi.

Sources

1. ADEL Signs $1.04 Billion Global License Agreement with Sanofi for ADEL-Y01, a Novel investigational Alzheimer's Disease Therapy ADEL Inc. December 15, 2025 https://www.prnewswire.com/news-releases/adel-signs-1-04-billion-global-license-agreement-with-sanofi-for-adel-y01--a-novel-investigational-alzheimers-disease-therapy-302642662.html
2. Dren Bio Expands Strategic Collaboration with Sanofi to Develop Next-Generation B-Cell Depletion Therapy Dren Bio December 15, 2025 https://www.businesswire.com/news/home/20251215349902/en/Dren-Bio-Expands-Strategic-Collaboration-with-Sanofi-to-Develop-Next-Generation-B-Cell-Depletion-Therapy