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Last update 29 Jul 2026
Teriflunomide
Last update 29 Jul 2026
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms (Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide, Teriflunomide, Teriflunomide (USAN) + [11] |
Target |
Action inhibitors |
Mechanism DHODH inhibitors(Dihydroorotate dehydrogenase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (12 Sep 2012), |
RegulationOrphan Drug (South Korea) |
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Structure/Sequence
Molecular FormulaC12H9F3N2O2 |
InChIKeyUTNUDOFZCWSZMS-YFHOEESVSA-N |
CAS Registry163451-81-8 |
Related
63
Clinical Trials associated with TeriflunomideNCT07189325
A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.
Start Date15 Jun 2026 |
Sponsor / Collaborator |
IRCT20130313012810N66
Bioequivalence study of the Teriflunomide 14 mg tablets manufactured by Noavaran Daroui Kimia Pharmaceutical Company vs. Aubagio® Tablets manufactured by Sanofi Pharmaceutical Company
Start Date01 Oct 2025 |
Sponsor / Collaborator- |
NCT07065968
Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
Start Date19 Aug 2025 |
Sponsor / Collaborator |
100 Clinical Results associated with Teriflunomide
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100 Translational Medicine associated with Teriflunomide
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100 Patents (Medical) associated with Teriflunomide
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1,310
Literatures (Medical) associated with Teriflunomide01 Aug 2026·Multiple Sclerosis and Related Disorders
Discontinuation of disease-modifying therapies in patients with multiple sclerosis: A retrospective case-control study
Article
Author: Gil Martinez, L ; Pastor González, R ; Mena García, N ; Llanes Ferrer, A ; Campos Jiménez, M ; Cabañas Engenios, G ; Garay Albízuri, P ; Masjuan Vallejo, J ; Chico García, J L ; Sainz De La Maza, S ; Villar, L M ; Monreal Laguillo, E ; Rodríguez Jorge, F ; Romero Ferro, J ; Sánchez Asensio, A ; Costa-Frossard, L
INTRODUCTION:
The long-term benefit-risk balance of disease-modifying therapies (DMTs) in multiple sclerosis (MS) becomes increasingly relevant with ageing and prolonged disease stability. Discontinuation of DMTs has been proposed for selected patients, but its impact on disability progression remains uncertain.
OBJECTIVE:
To evaluate the effect of DMTs on confirmed disability progression (CDP) in patients with previously stable MS.
METHODS:
We conducted a single-center retrospective case-control study including patients with relapsing-onset MS followed between 2010 and 2025. Eligible patients had been clinically and radiologically stable for at least three years while receiving a moderate-efficacy DMT (injectables, teriflunomide or fumarates). Patients who discontinued were compared with those who continued treatment. The primary outcome was CDP at two years. Inverse probability of treatment weighting (IPTW) was applied to address imbalances in baseline data.
RESULTS:
118 patients were included (56 discontinuers and 62 continuers, median age 58.19 vs 51.63 respectively, p < 0.001, without differences in sex distribution or baseline EDSS). DMT discontinuation was associated with higher risk of CDP at two years (aOR=5.10; p = 0.031). No significant differences were observed in relapse rates, MRI activity, NEDA-3 status, or sNfL levels. The risk of PIRA was higher in the discontinuation group at two years (aOR = 5.96; p = 0.036). Among patients who discontinued, higher baseline EDSS was associated with subsequent CDP.
CONCLUSIONS:
Discontinuation of moderate-efficacy DMTs in stable MS patients may increase the risk of disability progression despite no clear increase in inflammatory activity.
01 Jul 2026·JOURNAL OF NEUROLOGY
The impact of age on efficacy and safety of disease modifying treatment—insights from the Austrian Multiple Sclerosis Treatment Registry
Article
Author: Enzinger, Christian ; Berger, Thomas ; Di Pauli, Franziska ; Guger, Michael ; Heschl, Bettina ; Gradl, Christiane ; Kalcher, Stefan ; Kvas, Erich
Abstract:
Introduction:
Efficacy and safety considerations in the treatment of multiple sclerosis (MS) change over a person's lifetime due to immunosenescence and the increasing prevalence of comorbidities with advancing age.
Objectives/aims:
To evaluate the overall efficacy and safety of disease-modifying therapies in MS patients across different age groups using prospectively collected real-world data from a nationwide observational cohort.
Methods:
We included patients from the Austrian MS Treatment Registry (AMSTR) who were receiving treatment with Alemtuzumab, Cladribine, Dimethyl fumarate, Fingolimod, Natalizumab, Ocrelizumab, Ofatumumab, Ozanimod, Ponesimod, Siponimod, and Teriflunomide for at least 12 months as of March 2025. Patients were categorized into two age groups: < 50 years (n = 1,459) and ≥ 50 years (n = 658).A generalized linear model (GLM) and Cox proportional hazards models were applied to assess treatment effects on annualized relapse rates (ARR) and changes in the Expanded Disability Status Scale (EDSS), including both progression and improvement.
Results:
Over a mean treatment duration of 6.0 years (younger cohort) and 7.8 years (older cohort), the estimated mean ARR was 0.12 and 0.09, respectively (p < 0.001). Cox regression analysis of time to first relapse yielded a hazard ratio (HR) of 1.34 (95% CI 1.12–1.60, p = 0.001), indicating a significantly higher relapse risk for the younger cohort.For sustained EDSS progression at 12 and 24 weeks, the corresponding HRs were 0.76 (95% CI 0.64–0.912, p = 0.003) and 0.70 (95% CI 0.58–0.85, p < 0.001), respectively, demonstrating a higher risk of disability progression in the older cohort.
Conclusion:
Our findings indicate that approximately one-third of treated MS patients in our registry are aged 50 years or older, underscoring the substantial presence of older patients in contemporary MS treatment cohorts. Furthermore, efficacy outcomes, including ARR and EDSS progression, differed significantly between younger and older age groups. These results suggest that both disease activity and chronological age are primary determinants of treatment outcomes.
01 Jun 2026·Neurology and Therapy
Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis
Article
Author: Xu, Yihuan ; Steinman, Lawrence ; Gocke, Anne ; Fox, Edward ; Cree, Bruce A C ; Wray, Sibyl ; Mok, Koby ; Arnold, Douglas L ; Hartung, Hans-Peter ; Robertson, Derrick ; Alvarez, Enrique ; Garner, Christopher A ; Qian, Peiqing
INTRODUCTION:
People with highly active multiple sclerosis benefit from early treatment with highly efficacious disease-modifying therapies. Here we present data on the efficacy of ublituximab versus teriflunomide in a subgroup of participants with highly active disease at baseline.
METHODS:
Pooled post hoc analyses of the phase 3 ULTIMATE I (N = 549) and II (N = 545) studies evaluated efficacy measures at weeks 12 and 96 in participants with highly active disease, defined as ≥ 2 relapses in the year prior and ≥ 1 gadolinium-enhancing (Gd+) T1 lesion at baseline.
RESULTS:
In the highly active disease population, the unadjusted annualized relapse rates (ARR) at week 96 were 0.145 and 0.496 for the ublituximab (n = 88) and teriflunomide (n = 80) groups, respectively (70.8% relative reduction, P < 0.001). The number (least squares means) of gadolinium-enhancing T1 lesions per scan for ublituximab versus teriflunomide was 0.114 versus 0.683 at week 12 (83.3% relative reduction) and 0.038 versus 0.875 at week 96 (95.6% relative reduction; both P < 0.001). Corresponding values for new/enlarging T2 lesions (ublituximab versus teriflunomide) were 1.754 versus 4.127 at week 12 (57.5% relative reduction) and 0.568 versus 6.367 at week 96 (91.1% relative reduction, both P < 0.001). No evidence of disease activity-3 (NEDA-3) rates with ublituximab versus teriflunomide were 29.5% versus 10.1% (P = 0.001) at week 12 and 77.9% versus 16.4% (P < 0.001) at week 96 (weeks 24-96, re-baselined).
CONCLUSION:
Ublituximab was associated with significant treatment benefits across multiple efficacy measures versus teriflunomide in participants with highly active disease at baseline.
TRIAL REGISTRATION:
Clinical trial registry: ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 (registration date September 7, 2017) and NCT03277248 (registration date September 7, 2017).
275
News (Medical) associated with Teriflunomide23 Jul 2026
Group sales
were +6% at constant exchange rates (CER)
1
, -2% when reported in CHF and +8% in USD
2
, in the first six months, driven by high demand for innovative medicines and diagnostics.
Pharmaceuticals Division sales
were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers.
Diagnostics Division sales
were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions.
Core operating profit
was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue;
IFRS operating profit
was -6% in CHF due to the appreciation of the Swiss franc.
Core earnings per share
were +9% at CER (-2% in CHF);
IFRS diluted earnings per share
were -8% in CHF due to the appreciation of the Swiss franc.
Highlights:
US Priority Reviews for
giredestrant
in an early-stage breast cancer,
Enspryng
in thyroid eye disease,
Tecentriq
in colon cancer as well as
Gazyva/Gazyvaro
in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys
US acceptance of a supplemental Biologics License Application for the
Lunsumio
and
Polivy
combination for blood cancer and
Gazyva/Gazyvaro
for systemic lupus erythematosus
Positive phase III data on
divarasib
in lung cancer; presentation of promising data on
fenebrutinib
in multiple sclerosis (phase III),
Gazyva/Gazyvaro
in three autoimmune diseases (phase III) and
enicepatide
(CT-388) and
petrelintide
in obesity (phase II)
Launch of
Axelios 1
, a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale
EU CE mark for two blood tests:
Elecsys pTau217
to detect Alzheimer’s pathology and
Elecsys IGRA TB
to identify latent tuberculosis infection
US approval for
Ventana PTEN (SP218) RxDx Assay
, the first companion diagnostic to assess the levels of a key protein in prostate cancer
Global collaboration agreement with
Nurix Therapeutics
for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology
Agreement to acquire
PathAI
to transform AI-driven diagnostics
Outlook for 2026 confirmed.
Outlook for 2026
Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.
Key figures
CHF millions
% change
January–June
2026
2025
At CER
1
In CHF
In USD
Group sales
30,364
30,944
6
-2
8
Pharmaceuticals Division
23,629
23,985
6
-1
8
Diagnostics Division
6,735
6,959
3
-3
6
Core operating profit
11,856
12,010
10
-1
Core EPS – diluted (CHF)
10.85
11.08
9
-2
IFRS operating profit
9,671
10,330
6
-6
Roche CEO Thomas Schinecker
: “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development.
We reported positive phase III data for
divarasib
, reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews:
giredestrant
in early-stage breast cancer,
Enspryng
in thyroid eye disease,
Tecentriq
in colon cancer and
Gazyva/Gazyvaro
in two autoimmune kidney diseases.
In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective
Axelios 1
sequencing solution, alongside EU CE mark for key diagnostic tests, including the
Elecsys pTau217
blood test for Alzheimer’s pathology and the
Elecsys IGRA TB
blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide.
ezstandalone.cmd.push(function () {
ezstandalone.showAds(131);
});
Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.”
Group results
In the first six months of 2026, Roche
sales
were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates.
Core operating profit
was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue.
Core earnings per share
were +9% at CER (-2% in CHF).
IFRS operating profit
was -6% in CHF to CHF 9.7 billion.
IFRS diluted earnings per share
were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc.
Sales in the
Pharmaceuticals Division
were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth.
The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025.
Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025.
In the
United States
, sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis).
Sales in
Europe
were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo.
In
Japan
, sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra.
Sales in the
International
region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales.
The
Diagnostics Division’s
sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China.
Sales in the
Europe, Middle East and Africa (EMEA)
region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions.
In
North America
, sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas.
Sales in
Asia-Pacific
were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region.
In
Latin America
, sales were +10% at CER, or +5% when reported in CHF.
Pharmaceuticals: key developments
Compound
Milestone
Regulatory
Gazyva/Gazyvaro
Several autoimmune diseases
FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN)
The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus.
If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome.
pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years.
More information:
Media Release
, 15 July 2026
Enspryng
Thyroid eye disease
FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)
The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED.
Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED.
TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated.
More information:
Media Release
, 30 June 2026
Lunsumio and Polivy
Blood cancer
FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL)
Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death.
People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies.
If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment.
More information:
Media release
, 18 June 2026
Tecentriq
Colon cancer
FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer
Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone.
Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options.
If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery.
More information:
Media Release
, 11 June 2026
Giredestrant
Breast cancer
FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting
Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy.
Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years.
Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III).
The FDA has set a Prescription Drug User Fee Act date of 30 November 2026.
More information:
Media Release
, 2 June 2026
Phase III, pivotal and other key read-outs
Divarasib
Lung cancer
Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer
Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer.
Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed.
Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population.
More information:
Media Release
, 2 July 2026
Fenebrutinib
Multiple sclerosis
Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS)
Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS.
Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide.
Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS).
More information:
Media Release
, 22 April 2026
Other
Alzheimer’s integrated portfolio presentation
Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC
Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease.
New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care.
More information:
Media Release
, 7 July 2026
Nurix Therapeutics collaboration
Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology
Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies.
Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis).
Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors.
More information:
Media Release
, 8 June 2026
Obesity portfolio data presentation
Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions
Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity.
Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity.
A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option.
More information:
Media Release
,
1 June 2026
Oncology portfolio data presentation
Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer
New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages.
Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease.
Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers.
More information:
Media Release
, 19 May 2026
Ophthalmology portfolio data presentation
Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026
New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden.
Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions.
More information:
Media Release
, 30 April 2026
Pharmaceuticals sales
Sales
CHF millions
As % of sales
% change
January–June
2026
2025
2026
2025
At CER
In CHF
Pharmaceuticals Division
23,629
23,985
100.0
100.0
6
-1
United States
12,229
12,670
51.8
52.8
6
-3
Europe
4,520
4,566
19.1
19.0
1
-1
Japan
1,360
1,425
5.8
5.9
11
-5
International
5,520
5,324
23.3
22.3
10
4
International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Top 20 best-selling pharmaceuticals
Total
United States
Europe
Japan
International
CHF m
%
CHF m
%
CHF m
%
CHF m
%
CHF m
%
Ocrevus
Multiple sclerosis
3,470
7
2,300
2
758
10
-
-
412
30
Hemlibra
Haemophilia A
2,492
11
1,313
9
502
4
171
9
506
26
Vabysmo
Eye diseases (nAMD, DME, RVO)
2,059
8
1,333
1
386
5
75
26
265
65
Tecentriq
Cancer immunotherapy
1,704
6
815
9
410
-3
146
-2
333
17
Xolair
3
Chronic hives, food allergies
1,673
27
1,673
27
-
-
-
-
-
-
Perjeta
3
Breast cancer
1,389
-7
551
-11
238
-14
24
-23
576
0
Phesgo
Breast cancer
1,318
18
318
0
425
9
88
15
487
47
Actemra/RoActemra
3
RA, COVID-19
1,074
-9
515
-9
238
-21
140
8
181
-3
Evrysdi
Spinal muscular atrophy
968
17
323
15
335
17
39
-1
271
25
Kadcyla
3
Breast cancer
916
-6
310
-14
248
-4
39
2
319
3
Polivy
Blood cancer
808
20
381
28
128
-18
98
16
201
47
Alecensa
Lung cancer
795
6
261
4
126
-4
93
8
315
13
MabThera/Rituxan
3
Blood cancer, RA
609
5
402
14
62
-9
6
-11
139
-10
Activase/TNKase
3
Cardiac diseases
555
11
531
11
-
-
-
-
24
12
Gazyva/Gazyvaro
3
Blood cancer, lupus nephritis
489
7
240
4
117
-1
17
14
115
21
Herceptin
3
Breast and gastric cancer
462
-12
94
-14
136
-7
2
-36
230
-14
Avastin
3
Various cancer types
414
-15
125
-12
35
37
36
-44
218
-13
Pulmozyme
3
Cystic fibrosis
204
-8
145
-5
29
-11
-
26
30
-18
Columvi
Blood cancer
196
70
91
28
53
116
-
-
52
173
Enspryng
Acute inflammation of brain, spinal cord and optic nerves
195
22
50
20
23
20
79
18
43
37
DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis
Diagnostics: key developments
Product
Milestone
cobas HDV test
Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis
The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response.
Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types.
The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available.
More information:
Media Release
, 14 July 2026
Elecsys IGRA TB test
Roche receives CE mark for blood test to identify tuberculosis infection
The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets.
Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions.
The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient.
More information:
Media Release
, 9 July 2026
Axelios 1 sequencing platform
Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform
Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications.
Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours.
The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future.
More information:
Media Release
, 29 June 2026
Ventana PTEN (SP218) RxDx Assay
Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer
The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap.
In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments.
The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes.
More information:
Media Release
, 12 June 2026
Liver Disease Panel
Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management
Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management.
The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis.
With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer.
More information:
Media Release
, 27 May 2026
Elecsys pTau217 test
Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217)
Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world.
While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw.
Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world.
More information:
Media Release
, 12 May 2026
PathAI agreement
Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics
PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency.
Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools.
These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients.
More information:
Media Release
, 7 May 2026
Diagnostics sales
Sales
CHF millions
As % of sales
% change
January–June
2026
2025
2026
2025
At CER
In CHF
Diagnostics Division
6,735
6,959
100.0
100.0
3
-3
Customer areas
Core Lab
3,756
3,839
55.8
55.2
4
-2
Molecular Lab
1,196
1,250
17.7
18.0
3
-4
Near Patient Care
909
1,018
13.5
14.6
-5
-11
Pathology Lab
874
852
13.0
12.2
11
3
Regions
Europe, Middle East, Africa
2,466
2,485
36.6
35.7
3
-1
North America
2,211
2,235
32.8
32.1
8
-1
Asia-Pacific
1,522
1,729
22.6
24.9
-5
-12
Latin America
536
510
8.0
7.3
10
5
More information on Roche’s performance in the first six months of 2026:
Half-Year 2026 Presentation
Half-Year 2026 Presentation with appendix
Half-Year 2026 Finance Report
Appendix with tables
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit
.
All trademarks used or mentioned in this release are protected by law.
References
[1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025.
[2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies.
[3] Products launched before 2015.
Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.
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Phone: +41 79 407 72 58
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Roche Investor Relations
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Phone: +1 650 225 32 17
E-mail: kalm.loren@gene.com
Attachments
Media & Investor Release Roche HY 2026 EN
Communications appendix tables_HY_Results_13072026
Clinical ResultPhase 2Phase 3Drug Approval
04 Jul 2026
A UCLA study has identified a hidden Achilles' heel in aggressive small cell cancers that have resisted new treatments for decades. Scientists found that tumors lacking the RB gene become critically dependent on the protein E2F3 for survival. Blocking E2F3 shut down tumor growth in laboratory models, and existing FDA-approved drugs may be able to exploit this vulnerability. The discovery could pave the way for faster development of more effective therapies.Researchers at UCLA have identified a hidden weakness in some of the most aggressive and difficult-to-treat cancers, raising hopes for a new way to attack tumors that have resisted treatment for decades.
Small cell neuroendocrine cancers can develop in the lung, prostate, and ovary. These fast-growing tumors tend to spread early and have remained among the hardest cancers to treat successfully.
A key feature of these cancers is the loss of a gene called RB. Under normal conditions, RB helps keep cell growth under control. When the gene is missing, cancer cells multiply rapidly and become resistant to many targeted therapies.
Now, a new study published in Proceedings of the National Academy of Sciences suggests that losing RB also creates an unexpected vulnerability that researchers believe could become a powerful treatment target.
A Hidden Dependency in Deadly Cancers
The UCLA team discovered that cancer cells lacking RB become heavily dependent on a protein called E2F3 to survive. In laboratory experiments, blocking E2F3 prevented tumor growth through a process known as "synthetic lethality."
In simple terms, cancer cells can survive without RB, but they cannot survive when both RB and E2F3 are lost. Removing E2F3 alongside the missing RB exposes a critical weakness that researchers believe could be exploited with future therapies.
"Discovering a vulnerability like this opens the door to thinking about entirely new treatment strategies," said study senior author Dr. Owen N. Witte, who holds the Presidential Chair in Developmental Immunology in the Department of Microbiology, Immunology, and Molecular Genetics and is a member of the UCLA Health Jonsson Comprehensive Cancer Center. "That's especially important because there has not been a major change in how we treat these cancers for decades. When I first encountered these tumors as a medical student more than 50 years ago, the survival statistics were essentially the same as they are today."
Building Better Models To Study Small Cell Cancer
Progress against small cell neuroendocrine cancers, especially those that develop in the prostate, has been slowed by the lack of realistic laboratory models. Without them, scientists have struggled to identify the genes these tumors rely on and uncover their biological weaknesses.
To overcome that challenge, the UCLA researchers engineered normal human prostate cells with five major cancer-causing genetic changes, including the loss of RB and TP53. The cells were grown into organoids and then used to produce tumors in mice, creating models that closely resemble human small cell prostate cancer.
The work builds on more than a decade of research by Witte's laboratory to develop specialized models of small cell neuroendocrine prostate cancer.
CRISPR Screens Reveal a Shared Weakness
Using these models, the team performed genome-wide CRISPR screens that examined thousands of genes to determine which ones were essential for cancer cell survival.
The researchers identified nearly 1,400 genes that play important roles in keeping the cancer cells alive. Among the most significant discoveries was that small cell cancers from different organs all shared a strong dependence on E2F3.
When the scientists reduced E2F3 levels in RB-deficient cancer cells, the tumors stopped dividing, could no longer form clusters, and in some cases died completely.
"It's not that the two genes do the same thing," said Witte, who is also the founding director emeritus of the UCLA Broad Stem Cell Research Center and co-director of the Parker Institute of Cancer Immunotherapy Center at UCLA. "But the combination of what they do together becomes essential for the cancer cell. Losing one gene may not matter much, but losing both has a dramatic effect on tumor growth."
"These new model systems allowed us to uncover a genetic vulnerability that would have been very difficult to find otherwise," added first author Dr. Evan Abt, an assistant professor of Molecular and Medical Pharmacology at the David Geffen School of Medicine at UCLA.
Existing FDA-Approved Drugs May Offer a Shortcut
Because no medicines currently target E2F3 directly, the researchers looked for another way to exploit the cancer's weakness.
They found that blocking a metabolic pathway involved in producing DNA building blocks by inhibiting an enzyme called DHODH lowered E2F3 levels and slowed tumor growth.
That finding is especially intriguing because DHODH inhibitors, including leflunomide and teriflunomide, are already FDA-approved to treat autoimmune diseases. Repurposing existing medications could potentially speed the development of new therapies for patients with these cancers.
"What's exciting is that our findings open the door to applying existing drugs in a new way," Abt said. "By understanding how these cancers depend on E2F3, we can start to think about strategies that might work much more quickly in patients."
Although the research remains in its early stages, the findings provide important new insight into how these aggressive cancers survive and point toward a promising new direction for future treatments.
Other UCLA authors are Liang Wang, Grigor Varuzhanyan, Jack Freeland, Tian He, Guadalupe M. Peña-Garcia, Lauryn Ruegg, Jami McLaughlin, Donghui Cheng, Nikolas G. Balanis, Chia-Chun Chen, Sanaz Memarzadeh, Caius G. Radu and Thomas G. Graeber.
Immunotherapy
26 Jun 2026
Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses
Cenrifki represents a significant advancement for people living with SPMS by targeting disability progression
Approval based on the HERCULES phase 3 study in nrSPMS with supporting data from the GEMINI 1 and 2 phase 3 studies in RMS
Paris, June 23, 2026
. The European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. This follows the
positive opinion
by the European Medicines Agency's Committee for Medicinal Products for Human Use.
The approval is based on results from the HERCULES phase 3 study (clinical study identifier:
NCT04411641
) in non-relapsing SPMS (nrSPMS), with supporting data from the GEMINI 1 (clinical study identifier:
NCT04410978
) and GEMINI 2 (clinical study identifier:
NCT04410991
) phase 3 studies in relapsing multiple sclerosis (RMS). The HERCULES study demonstrated that Cenrifki significantly delayed the onset of disability progression in nrSPMS.
The safety pro Cenrifki has been consistent across the clinical program. The most common adverse events were COVID-19 and upper respiratory tract infections. Significant liver enzyme elevations were also observed. Drug-induced liver injury (DILI) is an identified safety risk of Cenrifki. Strict adherence to liver monitoring requirements, and prompt management of liver enzyme elevations, are important to mitigate DILI risk.
Sanofi will make Cenrifki commercially available in Germany this year in close collaboration between local medical teams, treating MS specialists and their patients, all supported by the required Risk Management Program and robust Patient Support Program. This reflects Sanofi’s commitment to a careful approach to introducing this innovative, first-in-class medicine for people living with SPMS without relapses.
About secondary progressive multiple sclerosis
SPMS is a debilitating stage of MS where patients experience continuous accumulation of disability, including fatigue, cognitive impairment, mobility difficulties, and loss of independence – often without available treatment options. Across major European economies, the yearly cost of MS-related disability surpasses the average annual income per person. As disability accumulates, many are forced to reduce working hours or leave the workforce entirely — while up to 82% of those living with severe MS rely on informal caregiving, extending the strain far beyond the individual. Addressing disability progression remains one of the most significant unmet needs in MS care.
About HERCULES
HERCULES (clinical study identifier:
NCT04411641
) was a double-blind, randomized phase 3 clinical study evaluating the efficacy and safety of tolebrutinib in patients with nrSPMS. At baseline, nrSPMS was defined as having a SPMS diagnosis with an expanded disability status scale (EDSS) between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months. Participants were randomized (2:1) to receive either an oral daily dose of tolebrutinib or matching placebo for up to approximately 48 months.
The primary endpoint was six-month confirmed disability progression (CDP) defined as the increase of ≥1.0 point from the baseline EDSS score when the baseline score is ≤5.0, or the increase of ≥0.5 point when the baseline EDSS score was >5.0. Secondary endpoints included time to onset of three-month CDP as assessed by EDSS score, total number of new or enlarging T2 hyperintense lesions as detected by MRI, time to onset of confirmed disability improvement, 3-month change in 9-hole peg test and timed 25-foot walk test, as well as the safety and tolerability of tolebrutinib.
About GEMINI 1 and 2
GEMINI 1 (clinical study identifier:
NCT04410978
) and GEMINI 2 (clinical study identifier:
NCT04410991
) were double-blind, randomized phase 3 clinical studies evaluating the efficacy and safety of tolebrutinib compared to teriflunomide, an oral disease-modifying medicine, in patients with RMS. Participants were randomized in both studies (1:1) to receive either tolebrutinib and placebo daily or 14 mg teriflunomide and placebo.
The primary endpoint for both studies was the annualized relapse rate for up to approximately 36 months defined as the number of confirmed adjudicated protocol defined relapses. Secondary endpoints included time to onset of confirmed disease worsening, confirmed over at least six months, defined as an increase of ≥1.5 points from the baseline EDSS score when the baseline score is 0, an increase of ≥1.0 point from the baseline EDSS score when the baseline score is 0.5 to ≤5.5 or an increase of ≥0.5 point from the baseline EDSS score when the baseline score was >5.5 in addition to the total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from baseline through the end of study, the total number of Gd-enhancing T1 hyperintense lesions as detected by MRI from baseline through the end of study, and the safety and tolerability of tolebrutinib.
About Cenrifki
Cenrifki (tolebrutinib) is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in MS. This unique mechanism of action addresses the underlying biology of progressive MS by targeting the inflammatory processes that contribute to disability accumulation. Cenrifki is the first disease-targeting therapy designed to address the underlying process of MS disability accumulation approved in the EU for adults with SPMS without relapses in the last two years.
Cenrifki is administered once daily with a meal, and treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Cenrifki is also approved in Australia for the treatment of nrSPMS and to slow disability accumulation in the absence of relapse activity with SPMS and in the United Arab Emirates for the treatment of SPMS without relapses in the last two years.
Cenrifki represents Sanofi's commitment to developing innovative treatments that address the underlying causes of neurological diseases and potentially transform the treatment landscape. Standing at the intersection of neurology and immunoscience, Sanofi is focused on improving the lives of those living with serious neuro-inflammatory and neuro-degenerative conditions including MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, age-related macular degeneration, and other neurological diseases. The neurology pipeline currently has several projects in phase 3 studies across various diseases.
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
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Sanofi Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including 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 and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. 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, uncertainties and assumptions 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; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; 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 pending or 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 French Markets Authority (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, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein.
All trademarks mentioned in this press release are the property of the Sanofi group.
Attachment
Press_Release
Phase 3Clinical ResultDrug Approval
100 Deals associated with Teriflunomide
Login to view more data
External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10172 | Teriflunomide |
R&D Status
Approved
10 top approved records. to view more data
Login
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Multiple Sclerosis, Relapsing-Remitting | European Union | 26 Aug 2013 | |
| Multiple Sclerosis, Relapsing-Remitting | Iceland | 26 Aug 2013 | |
| Multiple Sclerosis, Relapsing-Remitting | Liechtenstein | 26 Aug 2013 | |
| Multiple Sclerosis, Relapsing-Remitting | Norway | 26 Aug 2013 | |
| Multiple sclerosis relapse | South Korea | 18 Jul 2013 | |
| Multiple Sclerosis | United States | 12 Sep 2012 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Radiologically isolated syndrome | Phase 3 | France | 25 Sep 2017 | |
| Radiologically isolated syndrome | Phase 3 | France | 25 Sep 2017 | |
| Radiologically isolated syndrome | Phase 3 | Switzerland | 25 Sep 2017 | |
| Radiologically isolated syndrome | Phase 3 | Switzerland | 25 Sep 2017 | |
| Radiologically isolated syndrome | Phase 3 | Turkey | 25 Sep 2017 | |
| Radiologically isolated syndrome | Phase 3 | Turkey | 25 Sep 2017 | |
| Influenza, Human | Phase 2 | Austria | 01 Sep 2011 | |
| Influenza, Human | Phase 2 | Canada | 01 Sep 2011 | |
| Influenza, Human | Phase 2 | Germany | 01 Sep 2011 | |
| Influenza, Human | Phase 2 | Russia | 01 Sep 2011 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Not Applicable | 805 | Platform therapies | jnmhrrkjms(qroanctneq) = innkqyqvcu iqfjnupjky (hiemzvotle ) View more | Positive | 21 Jun 2025 | ||
Intermediary active drugs | jnmhrrkjms(qroanctneq) = oekcnubivk iqfjnupjky (hiemzvotle ) View more | ||||||
Phase 3 | 1,882 | (non-Hispanic Black) | dyelmmgxee(ajpjdhadkk) = pxdsfecrss vvsyhdspvx (slphuqkmdx ) | Positive | 17 Jul 2024 | ||
(non-Hispanic Black) | dyelmmgxee(ajpjdhadkk) = dlrtboyvdy vvsyhdspvx (slphuqkmdx ) | ||||||
Phase 3 | - | rqmgdrbisv(statjndzoa) = two children who developed pancreatitis in the teriflunomide/teriflunomide group rbkhatejbl (mpintiwoln ) View more | Positive | 15 Apr 2024 | |||
Placebo | |||||||
Not Applicable | 930 | xnbxgmpayo(kzlkcwlboa) = bxreydkrqn dfyqbfgyxu (kexwoiahti ) | Negative | 09 Apr 2024 | |||
xnbxgmpayo(kzlkcwlboa) = ctldnyorvu dfyqbfgyxu (kexwoiahti ) | |||||||
Phase 4 | Multiple sclerosis relapse ABCG2 polymorphisms | - | rpzprvkmal(jamzktbaos) = ysmplckwxs soswljosxl (npdfhhxzry, 769.0) View more | Positive | 05 Feb 2024 | ||
(Variant ABCG2) | rpzprvkmal(jamzktbaos) = msprvfjwqo soswljosxl (npdfhhxzry, 1053.0) View more | ||||||
Not Applicable | 325 | aeeotbxoao(hnhcdxlmnq) = DMT-naive experienced a greater and significant reduction (improvement) in psychological MSIS-29 score at month 24 compared to switch group zorycqmixq (ywjjutrdks ) | Positive | 25 Apr 2023 | |||
Phase 3 | Multiple sclerosis relapse spinal cord atrophy | 3D MUCSC conformational analysis | 799 | Placebo | irajyskkji(lkoqfoamfw) = pnczfyfofu qdfvxgmsyd (ikjoikasxe ) | Negative | 25 Apr 2023 | |
irajyskkji(lkoqfoamfw) = nagktzaqpx qdfvxgmsyd (ikjoikasxe ) | |||||||
Phase 3 | 166 | yksobotqhl(tobxcqptnd) = zovexpprqp dwcdjuaxgc (zpnyzeerqg ) | - | 12 Jan 2023 | |||
Placebo | yksobotqhl(tobxcqptnd) = qbfqvjuodv dwcdjuaxgc (zpnyzeerqg ) | ||||||
Phase 4 | 55 | nlpmfcycli = qdzsjfarmz vzkimhybzg (rzhbdyvlhy, xidglpdomb - aexiixawok) View more | - | 20 Oct 2022 | |||
Not Applicable | 1,000 | womuccqivz(dfcelvpoiu) = wkfdpdrdeh nvkrxkawle (hahljiwnri ) | - | 12 Oct 2022 |
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