The Sanofi pipeline in 2025: Is the play-to-win strategy working?  

Last November, we unpacked Sanofi’s play-to-win strategy, following the announcement of the divestment of a 50% controlling share of Opella, its consumer health division. At the time, the thesis was simple: slim down, free up capital, and lean into higher-impact medicines. In 2025, that pivot is now fully visible in Sanofi’s pipeline. Sanofi closed the 50% sale of Opella to CD&R in April, recasting itself as a focused biopharma and unlocking fresh firepower for R&D. 

Ten months on, the pattern is clearer in the deals ledger. Three company acquisitions: Blueprint Medicines closed July 18, Vigil Neuroscience closed August 6, and Vicebio agreement signed July 22; plus an asset acquisition of DR-0201 from Dren Bio completed May 27. Together, they tilt the pipeline toward immunology, add optionality in neurology, and diversify vaccine tech beyond mRNA. 

At the same time, late-stage execution has changed the pipeline’s complexion. Dupixent landed U.S. approvals in chronic spontaneous urticaria (CSU) and bullous pemphigoid, while Qfitlia (fitusiran) won U.S. approval on March 28 for prophylaxis in hemophilia A or B: three milestones that reinforce the near-term growth engine as new assets come in.  

A deeper look into Sanofi’s 2025 pipeline shopping cart 

Sanofi’s Blueprint Medicines acquisition  

• Deal completed:  July 18, 2025 

• Deal value: $9.1 billion  

Sanofi’s deal for Blueprint brings an approved therapy for systemic mastocytosis (SM), Ayvakit (avapritini), and a team steeped in mast-cell and KIT biology. SM is a rare, mast-cell-driven disorder that sits close to Sanofi’s immunology and hematology networks.  

KIT is a receptor tyrosine kinase found on mast cells. In SM, the KIT D816V mutation keeps that receptor permanently switched on, driving mast-cell accumulation and symptoms. Avapritinib and elenestinib (BLU-263) are selective inhibitors of KIT D816V, which is present in the vast majority of adult SM cases. 

Beyond the marketed asset Ayvakit, the acquisition adds early programs in KIT-driven diseases that aim to broaden treatment to less-advanced or adjacent patient groups. Strategically, that complements Sanofi’s existing immunology footprint, but execution will hinge on sustaining Ayvakit while moving next-wave KIT assets efficiently through development. 

Sanofi’s Vigil Neuroscience acquisition

• Deal completed: August 6, 2025 

• Deal value: $470 million 

Sanofi’s Vigil buy adds VG-3927, a first-in-class, oral small-molecule agonist of TREM2, a lipid-sensing receptor on microglia. In Alzheimer’s, loss-of-function variants in TREM2 impair microglial responses, and activating TREM2 is expected to enhance microglia’s neuroprotective functions without triggering broad pro-inflammatory activation. Vigil reported positive phase 1 results in January 2025, and a phase 2 trial is already planned in Alzheimer’s. 

Beyond the company’s lead asset, Sanofi acquires the full Vigil pre-clinical neurodegenerative pipeline. However, the TREM2 agonist antibody iluzanebart (VGL101), which Vigil had been developing for rare microgliopathies, was excluded from the acquisition, and rights reverted to Amgen under the original licensing arrangement.  

Sanofi to acquire Vicebio 

• Agreement announced: July 22, 2025  

• Deal value: $1.15 billion upfront – up to $450 million in milestones 

Sanofi’s agreement to buy Vicebio brings a platform designed to stabilize viral fusion proteins in their prefusion state, the form that exposes the most protective targets to the immune system. Vicebio’s second-generation “Molecular Clamp” technology acts like a tiny brace that locks the respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) F proteins in prefusion, so the immune system trains on the right shape and the proteins stay stable in liquid at 2–8 °C, avoiding the need for ultra-cold supply chains. 

The company’s lead candidate, VXB-241, is in an exploratory phase 1, and Vicebio is also advancing a trivalent preclinical candidate, VXB-251. 

The acquisition, a year after Vicebio closed a $100 million series B round, complements well Sanofi’s Beyfortus, developed for infant RSV prevention, with an adult combo path and adds a non-mRNA platform designed for multivalent, fridge-stable shots that can flow through Sanofi’s existing manufacturing and distribution. The near-term question is straightforward: do further clinical data confirm the immunogenicity and manufacturability advantages suggested preclinically? 

Sanofi’s deal for Dren Bio’s DR-0201 

• Deal completed: May 27, 2025 

• Deal value: $600 million upfront – up to $1.3 billion milestone payments 

DR-0201 is a bispecific antibody designed to remove B cells by enlisting myeloid cells, like macrophages. One arm recognizes a B-cell marker (CD20) while the other binds a myeloid-cell receptor, bringing the two cells together to trigger phagocytosis, so the myeloid cell ingests and clears the B cell. Dren Bio describes DR-0201 as capable of deep B-cell depletion, potentially reaching tissue-resident B cells that can persist after standard anti-CD20 therapy.  

Clinically, DR-0201 is already in phase 1 in two settings: relapsed/refractory B-cell non-Hodgkin lymphoma and a basket study in autoimmune diseases. These early trials are reading out whether deeper depletion translates into meaningful improvement in hard-to-treat, tissue-involved disease. 

Sanofi didn’t buy Dren Bio, the company; it acquired the DR-0201 program via Dren Bio’s affiliate (Dren-0201, Inc.). Sanofi framed the rationale as broadening its immunology pipeline with a myeloid-engaging mechanism that had already shown robust B-cell depletion in preclinical and early clinical work, while Dren continues independently with its remaining pipeline. 

These acquisitions aren’t the only deals Sanofi closed this year; the French company was able to build on already established collaborations as well. 

The deals that filled the gap in Sanofi’s pipeline 

Sanofi takes phase 3 lead on duvakitug 

Sanofi and Teva are advancing duvakitug, an anti-TL1A monoclonal antibody, after phase 2b data supported moving into phase 3 for ulcerative colitis and Crohn’s disease. TL1A is a cytokine that amplifies gut inflammation and fibrosis, and blocking it has emerged as one of the most competitive new mechanisms in inflammatory bowel disease (IBD).  

Under the partners’ latest update, Sanofi will lead the phase 3 program and, if approved, commercialize in North America, Japan, much of Asia, and the rest of the world, while Teva leads commercialization in Europe.  

Licensing of two AI-discovered antibodies 

In April 2025, Sanofi signed an exclusive worldwide license for two bispecific antibodies discovered on Earendil/Helixon’s artificial intelligence (AI) and high-throughput platform: HXN-1002 (targets α4β7 and TL1A) and HXN-1003 (targets TL1A and IL-23).  

Conceptually, α4β7 helps direct immune cells to the gut, while TL1A and IL-23 are upstream drivers of intestinal inflammation. Pairing them aims to modulate trafficking and inflammatory signaling together. The deal amounts to $125 million upfront with $1.72 billion potential milestone payments for Earendil Labs. This expands Sanofi’s early immunology option value alongside its TL1A program with Teva. 

Targeted protein degradation with Nurix’s asset 

On June 2, 2025, Sanofi exercised its option to take an exclusive license to Nurix’s STAT6 program, including the development of the candidate NX-3911. The option triggered a $15 million payment, bringing total collaboration payments to $127 million, with up to $465 million in future milestones. 

Sanofi is no stranger to the IL-4/IL-13/STAT6 pathway: Dupixent (dupilumab) already blocks the shared IL-4Rα receptor to inhibit IL-4/IL-13 signaling that drives type-2 inflammation.  Whereas Dupixent blocks signaling by targeting the IL-4Rα receptor at the surface, NX-3911 is an oral targeted protein degrader designed to remove STAT6 inside the cell, shutting down that transcriptional program from the nucleus. 

By licensing Nurix’s NX-3911, an oral targeted degrader of STAT6, Sanofi adds an intracellular way to dampen the same pathway downstream, STAT6 being the transcription factor activated after IL-4/IL-13 signaling.  

Earlier in April 2025, Nurix also licensed a separate discovery program to Sanofi targeting another transcription factor for autoimmune disease, showing Sanofi’s broader interest in degrader-based immunology beyond STAT6. 

Arrowhead/Visirna, a cardiometabolic RNAi and China footprint for Sanofi 

In August 2025, Sanofi struck a Greater China rights deal with Visirna Therapeutics, a subsidiary of Arrowhead Pharmaceuticals created to develop Arrowhead’s cardiometabolic RNAi drugs in China – plozasiran, an RNA interference (RNAi) therapy that silences the APOC3 gene in the liver. Terms include $130 million upfront and up to $265 million in potential milestones. 

APOC3 is a small protein that slows the clearance of triglyceride-rich lipoproteins by inhibiting lipoprotein lipase and reducing hepatic uptake; people with naturally low APOC3 levels have much lower triglycerides and lower cardiovascular risk. By delivering a short RNA guide to hepatocytes, plozasiran turns down APOC3 production at the source, which in turn lowers plasma triglycerides, the core problem in familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG). 

Visirna completed a phase 3 trial in Chinese patients with FCS that met its primary and key secondary endpoints, then submitted a New Drug Application (NDA) in China, which was accepted in January 2025, and the program has been reported as under Priority Review in China. Sanofi’s deal arrives while that review is underway, giving it a near-term rare-disease asset if approval follows. 

Adagene investment keeping the discovery line warm  

In July 2025, Sanofi invested $25 million into Adagene and, at the same time, exercised an option on a third SAFEbody discovery program. The cash helps advance muzastotug (ADG126), Adagene’s anti-CTLA-4 antibody engineered with SAFEbody masking so it’s largely “off” in normal tissues and preferentially “on” in tumors. Sanofi also agreed to sponsor a combination trial of muzastotug in patients with advanced solid tumors. Adagene keeps worldwide rights to muzastotug, and Sanofi’s role remains one of investor and clinical sponsor. 

Adagene’s SAFEbody is a “masked antibody” design. The antigen-binding site is covered with a removable mask that’s cleaved by proteases enriched in the tumor microenvironment, restoring full binding mainly inside tumors. The aim is a wider therapeutic window for tough targets like CTLA-4, where unmasked antibodies can cause on-target, off-tumor toxicities.  

The drug has moved through phase 1b/2 testing, including plans to evaluate it in microsatellite-stable colorectal cancer (MSS-CRC), historically resistant to checkpoint blockade. The Sanofi-sponsored study adds a broader solid-tumor combination trial.  

Sanofi has worked with Adagene since 2022, and the new option gives Sanofi another SAFEbody discovery slot for a bispecific with undisclosed targets, while the muzastotug trial sponsorship lets Sanofi probe CTLA-4 combinations without owning the program. It’s a small check for early-stage optionality on a platform designed to improve the tolerability of potent immuno-oncology mechanisms. 

Beyond acquisitions and new licensing deals, Sanofi’s pipeline also progressed in 2025.  

The Sanofi pipeline advances in 2025 

2025 has been a busy label-expansion year for Dupixent: the FDA cleared it for chronic spontaneous urticaria (CSU) in April, the first new targeted therapy for CSU in over a decade, and for bullous pemphigoid (BP) in June, the first and only targeted medicine for this disease. Japan also approved Dupixent for chronic obstructive pulmonary disease (COPD), marking the first biologic for COPD in that market.  

The FDA accepted priority review on March 25 for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity. Shortly after, the New England Journal of Medicine (NEJM) published phase 3 results showing a benefit on disability progression in nrSPMS, while outcomes have been mixed in relapsing forms. 

On March 28, the FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce bleeding in hemophilia A or B, with or without inhibitors, bringing a siRNA modality into Sanofi’s marketed portfolio.  

Sanofi also broadened Sarclisa’s footprint in newly diagnosed multiple myeloma: Japan approved Sarclisa as a front-line option on February 25, and the EU granted approval on July 25 for transplant-eligible patients receiving VRd induction. 

Sanofi’s 2025 pipeline moves: Clear pattern or opportunism? 

Taken together, Sanofi’s 2025 business-development moves look more like a coherent build than opportunistic deal-collecting. The center of gravity is immunology: the Blueprint buy adds a marketed rare-immunology medicine, Ayvakit, and deep KIT/mast-cell expertise, while the DR-0201 asset brings a myeloid-engaging bispecific designed for deeper B-cell depletion, a mechanistic complement to Sanofi’s existing immune toolkit. Those two alone meaningfully thicken the company’s hand in immune-mediated disease and point to a franchise logic, rather than one-off bets. 

Sanofi’s re-entry into neurology is selective. The Vigil Neuroscience deal centers on VG-3927, an oral TREM2 agonist that works through microglia, a differentiated mechanism relative to amyloid/tau programs and, crucially, a scale of bet that avoids near-term phase-3 spend. Sanofi also took Vigil’s preclinical neurodegeneration programs, so the transaction seeds a pipeline rather than a single-asset flyer.  

Vaccines tell a similar story of platform diversification over headline chasing. The Vicebio agreement brings a prefusion “Molecular Clamp” approach and an RSV/hMPV bivalent (VXB-241), a practical fit for Sanofi’s global footprint and complementary to Beyfortus in RSV. It’s still early, phase 1, but strategically it extends respiratory coverage beyond mRNA and into multivalent, fridge-stable options. 

Zooming out, Sanofi reports 82 clinical-stage projects across its pipeline, with around 30 either in phase 3 or at registration in 2025. That broad clinical footprint with a meaningful late-stage layer suggests the 2025 deals are being used to densify existing franchises and add targeted options rather than to patch holes.  

All of this also reads as a hedge against the industry’s patent cliff, when exclusivity ends and generics and biosimilars compress revenue. Sanofi has recent loss-of-exclusivity scars, as Aubagio generics hit in 2023, and today’s growth engine, Dupixent, underpins guidance.  

So, spreading risk across multiple immunology mechanisms, TL1A, STAT6 degradation, deep B-cell depletion, KIT mast-cell disease, and diversifying with a selective neurology option, TREM2, and vaccine platforms that are harder to copy at scale is strategically sensible. It diversifies the intellectual property and the modalities around the same disease spaces, rather than relying on a single molecule’s clock. Notably, Dupixent’s U.S. patent should expire in 2031. 2025’s deals look designed to rebalance that exposure in the Sanofi pipeline while the late-stage base keeps delivering.