Sanofi (NASDAQ: SNY) secures EU nod for Teizeild to delay stage 3 type 1 diabetes
Rhea-AI Filing Summary
Sanofi reports that the European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and children aged eight years and older with stage 2 disease. Teizeild is described as the first disease‑modifying therapy for type 1 diabetes approved in the EU, based on the TN‑10 phase 2 trial.
In TN‑10, the median time to diagnosis of stage 3 type 1 diabetes was 48.4 months with Teizeild versus 24.4 months with placebo, and 57% of treated patients versus 28% on placebo remained in stage 2. Frequently observed side effects included transient lymphopenia and rash. Teizeild (known as Tzield outside the EU) is already approved for the same indication in several other countries, and additional regulatory reviews are ongoing.
Positive
- European Commission approval of Teizeild as the first disease‑modifying therapy for type 1 diabetes in the EU strengthens Sanofi’s autoimmune diabetes portfolio.
- Robust TN‑10 efficacy data show median time to stage 3 diagnosis extended from 24.4 to 48.4 months and a lower progression rate (43% vs 72%), supporting clinical value.
- Broad international regulatory footprint with approvals in the US, UK, China, Canada, Israel, Saudi Arabia, UAE and Kuwait indicates growing global market access for Teizeild/Tzield.
Negative
- None.
Insights
EU approval of Teizeild expands Sanofi’s type 1 diabetes franchise with disease‑modifying positioning.
The European Commission approval of Teizeild (teplizumab) for delaying stage 3 type 1 diabetes in stage 2 patients aged eight and older adds a new, disease‑modifying product to Sanofi’s portfolio. The company highlights it as the first such therapy approved in the EU, which can help differentiate it versus standard glucose‑management approaches that do not target the underlying autoimmune process.
The pivotal TN‑10 phase 2 trial supports clinical relevance: median time to stage 3 diagnosis was 48.4 months with Teizeild versus 24.4 months with placebo, and only 43% of treated patients progressed to stage 3 compared with 72% on placebo. The safety profile featured expected immune‑related events such as transient lymphopenia in
Commercial potential will depend on how quickly clinicians adopt screening for stage 2 type 1 diabetes and refer eligible patients, as well as reimbursement decisions in EU markets. The product is already approved for the same indication in the US, UK, China and several other countries, suggesting a coordinated global launch strategy, while Sanofi has paused work on a second application in recently diagnosed stage 3 disease as it evaluates next steps.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2026
Commission File Number: 001-31368
SANOFI
(Translation of registrant’s name into English)
46, avenue de la Grande Armée, 75017 Paris, FRANCE
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
1
In January 2026, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are incorporated herein by reference.
Exhibit Index
| Exhibit No. |
Description | |
| Exhibit 99.1 | Press Release dated January 12, 2026: Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes | |
| Exhibit 99.2 | Press Release dated January 15, 2026: Myqorzo and Redemplo approved in China | |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Dated: January 16, 2026 | SANOFI | |||||
| By | /s/ Alexandra Roger | |||||
| Name: Alexandra Roger | ||||||
| Title: Head of Legal Corporate & Finance | ||||||
3
Exhibit 99.1
| Press Release |
|
Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes
| • | Approval based on the TN-10 phase 2 study that demonstrated a significant delay of onset of stage 3 T1D in stage 2 T1D patients |
| • | Teizeild represents a potential significant change in the treatment of autoimmune T1D, preventing the natural disease progression protecting beta-cell function |
Paris, January 12, 2026. The European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Teizeild is the first T1D disease-modifying therapy approved in the EU, marking a significant milestone in the treatment of this progressive autoimmune disease. The approval is based on positive results from the TN-10 phase 2 study (clinical study identifier: NCT01030861) demonstrating that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo, in adults and children aged eight years and older with stage 2 T1D.
“We are pleased that, for the first time, we will be able to offer patients and families in the EU a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “We remain committed to working with external stakeholders across the EU to bring patients the benefits of Teizeild, a unique therapy that may prevent the natural progression of type 1 diabetes by protecting beta-cell function.”
At the end of the TN-10 phase 2 study, the proportion of patients who remained in stage 2 T1D was almost twice as high in the Teizeild group as in the placebo group (57% vs 28%). The safety profile was consistent with the one observed in previous studies of Teizeild. The most frequently observed adverse events were blood or bone marrow-related (transient lymphopenia) in 75% of the participants and dermatologic or skin-related (rash) in 36% of the participants.
Teizeild (known as Tzield outside the EU) is also approved in the US, the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait to delay the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. As previously communicated, following the positive CHMP recommendation for this newly approved indication, Sanofi has decided not to progress with a second application for Teizeild in recently diagnosed stage 3 T1D at this time. Next steps are under evaluation. Other regulatory reviews are ongoing.
About TN-10
The pivotal TN-10 phase 2 study was a randomized, placebo-controlled, double-blind study which evaluated Teizeild for the delay of stage 3 T1D in adults and children aged eight years and older diagnosed with stage 2 T1D (presence of at least two T1D-related autoantibodies and dysglycemia) who are relatives of people living with autoimmune T1D. Seventy-six participants aged eight to 45 were enrolled (Teizeild n=44, placebo n=32). They were randomized to receive a single 14-day course of either Teizeild or placebo.
The primary endpoint was the elapsed time from randomization to the clinical diagnosis of autoimmune stage 3 T1D (progression from stage 2 T1D to stage 3 T1D). Key secondary end points included safety and tolerability.
Results demonstrated that the median time to the diagnosis of stage 3 T1D was 48.4 months in the Teizeild group and 24.4 months in the placebo group. The disease was diagnosed in 19 (43%) of the participants who received Teizeild and in 23 (72%) of those who received placebo. The
hazard ratio for the diagnosis of type 1 diabetes (Teizeild vs. placebo) was 0.41 (95% CI: 0.22 to 0.78; p=0.006 by adjusted Cox proportional-hazards model). There were expected adverse events of rash and transient lymphopenia.
About Teizeild
Teizeild (teplizumab) is a CD3-directed monoclonal antibody. Teizeild is the first and only disease modifying therapy in autoimmune T1D; it was approved in the US in November 2022 to delay the onset of stage 3 type 1 diabetes in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. Other regulatory reviews are ongoing.
About autoimmune T1D
T1D is a progressive autoimmune disease where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. There are four stages to the progression of T1D:
| - | In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic. |
| - | In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells / beta cell function. |
| - | Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue. Management of stage 3 T1D requires daily and burdensome insulin replacement therapy. |
| - | Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta-cell function remains (it’s been estimated that beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta-cells have been rendered useless by the autoimmune attack. |
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
Sanofi Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
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Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com
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Sanofi Investor Relations
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Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group.
FAQ
What did Sanofi (SNY) report in this Form 6-K filing?
What is Teizeild and what is its approved use in the EU?
What key clinical results support Teizeild’s approval according to Sanofi?
What safety profile for Teizeild did Sanofi highlight?
In which other countries is Teizeild (Tzield) already approved?
Did Sanofi mention future regulatory or development plans for Teizeild?
