Pharmaceuticals

We regularly review our research and development pipeline so that we can give priority to advancing the most promising pharmaceutical projects.

Phase II and III clinical projects

The following table shows our most important drug candidates currently in Phase II of clinical testing:

The following table shows our most important drug candidates currently in Phase III of clinical testing:

The following material developments occurred in the first half of 2026:

Evuzamitide

• In May, Bayer announced positive topline results for the PET tracer iodine 124 evuzamitide (I 124 evuzamitide) currently in clinical development. The Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital, met the primary endpoints of sensitivity and specificity of positron emission tomography/computed tomography (PET/CT) with I 124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation. I 124 evuzamitide is an investigational PET radiotracer that has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and also has orphan drug status in the United States and the European Union. It is one of two investigational amyloid radiotracers that Bayer acquired at the end of 2025 from Attralus, Inc., United States. The compound is also known as AT-01.

Finerenone

• In March, the Phase III study FIND-CKD evaluating finerenone met its primary endpoint of significantly delayed kidney disease progression in patients with nondiabetic chronic kidney disease (CKD).

• In June, detailed results from the FIND-CKD study were presented at the 63^rd Congress of the European Renal Association (ERA) and simultaneously published in the New England Journal of Medicine. Finerenone showed a statistically significant and clinically meaningful improvement in the total estimated glomerular filtration rate (eGFR) slope (0.7 ml/minute/1.73 m²/year) versus placebo in addition to standard of care. Finerenone also significantly reduced the key secondary endpoint, a composite of cardiovascular-kidney outcomes.

Levonorgestrel-releasing intrauterine system

• The clinical Phase III trial investigating Mirena™ in the treatment of nonatypical endometrial hyperplasia (NAEH) was discontinued as part of the standardized evaluation process for clinical development programs following a comprehensive assessment of study progress, including enrollment feasibility.

Nurandociguat

• In June, the results of a Phase II trial for the investigational substance nurandociguat, a potent and selective soluble guanylate cyclase (sGC) activator under development for the treatment of patients with chronic kidney disease (CKD), were presented at the 63^rd Congress of the ERA. In the ALPINE 1 trial, nurandociguat achieved both the primary and the secondary endpoints by reducing the urinary albumin-to-creatinine ratio (UACR) in a well-treated population in which nearly all participants received RAS inhibitors and 70% were treated with SGLT2 inhibitors.

Filings and approvals

The most important drug candidates currently in the approval process are:

Aflibercept

• In March, the Ministry of Health, Labour and Welfare (MHLW) in Japan granted marketing authorization for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of patients with visual impairment due to macular edema following retinal vein occlusion including branch, central and hemiretinal vein occlusion.

Asundexian

• In April, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the marketing authorization application for the Factor XIa (FXIa) inhibitor asundexian as a treatment for prevention of ischemic stroke in patients after a noncardioembolic ischemic stroke or transient ischemic attack (TIA). Shortly thereafter, the CDE also granted Priority Review designation for asundexian. This status is granted for pharmaceuticals that, if approved, can significantly improve safety or efficacy in the treatment, prevention or diagnosis of serious illnesses.

• In May, the FDA accepted the New Drug Application and granted Priority Review designation for asundexian in this indication in the United States.

• Also in May, Japan’s Ministry of Health, Labour and Welfare (MHLW) accepted the New Drug Application for asundexian in this indication.

• In June, the European Medicines Agency (EMA) accepted and began assessing the marketing authorization application for asundexian in this indication.

Finerenone

• In March, the European Union granted Kerendia™ approval for a new indication in adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, i.e., HF with mildly reduced (HFmrEF) or preserved LVEF (HFpEF), based on the statistically significant and clinically meaningful Phase III data of the FINEARTS-HF study. In the EU, Kerendia™ (10 mg, 20 mg, 40 mg) is now indicated for the treatment of symptomatic chronic heart failure with LVEF ≥40% in adults, expanding its use beyond the existing indication in patients with chronic kidney disease associated with type 2 diabetes (10 mg, 20 mg).

• In May, China’s NMPA granted marketing authorization for a label extension for Kerendia™ to include the treatment of adults with heart failure with left ventricular ejection fraction (LVEF) ≥40% based on the Phase III data of the FINEARTS-HF study. Kerendia™ (10 mg, 20 mg, 40 mg) is now approved in China for the treatment of symptomatic chronic heart failure with LVEF ≥40% in adults, expanding its use beyond the existing indication in patients with chronic kidney disease associated with type 2 diabetes (10 mg, 20 mg).

• Also in May, the FDA accepted the supplemental New Drug Application (sNDA) and granted Priority Review designation for Kerendia™ for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D) due to its potential to address a critical treatment gap. The regulatory submission is supported by the positive results from the Phase III FINE-ONE study, which were presented in November 2025 as a “Featured High-Impact Clinical Trial” during the Opening Plenary session at the American Society of Nephrology’s (ASN) Kidney Week and published in the New England Journal of Medicine in March 2026.

Gadoquatrane

• The low-dose MRI contrast agent gadoquatrane was approved for the first time in Japan in March as well as in the United States in June under the brand name Ambelvist™ for use in adult and pediatric patients including term neonates. Bayer has submitted marketing authorization applications in additional markets worldwide. MRI contrast agents usually contain gadolinium. Gadoquatrane utilizes the lowest dose of gadolinium of all macrocyclic MRI contrast agents on the market, with an up to 60% reduction per examination while maintaining image quality.

Sevabertinib (HER2-mut inhibitor)

• In April, China’s NMPA approved sevabertinib as a monotherapy for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations who have received at least one prior systemic therapy.

• In May, the FDA granted Priority Review status for sevabertinib in the United States for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations. This underscores the active substance’s potential on approval to address a critical unmet medical need in connection with this serious disease.

Cell and gene therapy

Our cell and gene therapy development portfolio has given us new, potentially transformative treatment approaches that could intervene in disease mechanisms and ultimately stop or reverse them at some point in the future. Our development portfolio comprises seven projects in various stages of clinical development that cover several therapeutic areas with a high unmet medical need, with innovative programs in areas such as Parkinson’s disease, rare diseases and congestive heart failure.

The following material developments occurred in the first half of 2026:

• In April, AskBio announced the completion of enrollment for the Phase II trial of the gene therapy AB-1002 in heart failure. We also announced together with AskBio that Viralgen, an AskBio subsidiary, will supply its Parkinson’s disease gene therapy candidate on a commercial scale for the Phase II REGENERATE-PD trial.

• In May, AskBio announced that the first participant had been dosed in the Phase I/II trial investigating the gene therapy AB-1009 in late-onset Pompe disease (LOPD).

Chemoproteomics

The chemoproteomics platform technology of our US subsidiary Vividion Therapeutics, Inc. enables us to unlock a multitude of traditionally undruggable target molecules with precision oncology therapeutics.

The following material developments occurred in the first half of 2026:

• In June, Vividion Therapeutics, Inc. announced that the first patient had been dosed in a Phase Ib combination clinical trial evaluating VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The study is evaluating VVD-214 in patients with microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer.

External innovation

In the area of external innovation, progress was made as follows in the first half of 2026.

• We announced the acquisition of Perfuse Therapeutics in May and completed that transaction in mid-June. We therefore now hold the full rights pertaining to PER-001 intravitreal implant, a first-in-class, sustained-release small-molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of glaucoma and diabetic retinopathy (DR). This acquisition strategically fits with our strong footprint and expertise in ophthalmology.

• In June, we entered into a research collaboration with the biopharmaceutical tech company Iambic Therapeutics Inc. to accelerate drug discovery using artificial intelligence (AI). The collaboration is focused on small molecule discovery and will leverage Iambic’s AI-driven platform to identify hard-to-drug targets.