Bayer AG
German multinational conglomerate headquartered in Leverkusen, operating across pharmaceuticals, consumer healthcare, agricultural chemicals, seeds, and biotechnology; ranks among the world's largest biomedical companies by revenue.
Clinical Trials
2557
839 active
Approvals
330
Total approvals
Agencies
6
Regulatory bodies
Founded
1863
Not yet recruiting
16
0.6%
No Longer Available
8
0.3%
Terminated
98
3.8%
Recruiting
51
2.0%
Suspended
1
0.0%
Approved For Marketing
1
0.0%
Withdrawn
34
1.3%
Active, not recruiting
823
32.2%
Completed
1524
59.6%
NMPA
National Medical Products Administration
61
Approvals
EMA
European Medicines Agency
57
Approvals
PHILIPPINES
Philippines FDA
20
Approvals
SFDA
Saudi Food and Drug Authority
65
Approvals
NPRA
National Pharmaceutical Regulatory Agency
22
Approvals
CIMA_AEMPS
Spanish Agency for Medicines and Medical Devices
105
Approvals
- The FDA granted accelerated approval to Bayer's oral tyrosine kinase inhibitor HYRNUO (sevabertinib) for treatment-naive adults with locally advanced or metastatic nonsquamous NSCLC harboring HER2 TKD activating mutations. - Approval was based on SOHO-01 Cohort F data showing a 75% objective response rate (95% CI: 64%-85%) in 69 treatment-naive patients, with 73% of responders maintaining response at six months. - The indication expands sevabertinib's existing November 2025 accelerated approval, which covered patients with HER2 TKD activating mutations who had received prior systemic therapy. - Continued approval may depend on confirmatory benefit in the ongoing Phase III SOHO-02 trial comparing sevabertinib with standard of care in treatment-naive advanced HER2-mutated NSCLC.
- EpilepsyGTx and CDMO Viralgen have partnered to manufacture EPY201, an investigational AAV gene therapy for focal refractory epilepsy, ahead of first-in-human clinical trials. - Viralgen will deploy its proprietary Aava platform, which enables high-yield, scalable AAV manufacturing across serotypes and has supported production of 1,500 AAV batches. - EPY201 (AAV9-CAMK2A-EKC) is delivered directly into the seizure focus via intraparenchymal administration to reduce local neuronal hyperexcitability while limiting exposure beyond the target region. - Focal refractory epilepsy affects roughly 10 million patients worldwide, including two million across the US, UK and EU, and the first-in-human trial is expected to begin in the first half of 2027.
- AskBio presented baseline characteristics from the Phase 2 GenePHIT trial of the investigational gene therapy umiposgene parvec (AB-1002) at the European Society of Cardiology Congress in Munich, Germany. - GenePHIT randomized more than 170 participants across 64 sites in 12 countries, making it one of the largest gene therapy trials conducted in heart failure to date. - The enrolled population reflects a representative non-ischemic heart failure with reduced ejection fraction (HFrEF) cohort receiving guideline-directed medical therapy. - Initial efficacy and safety outcomes from GenePHIT are expected in the first half of 2027.
- The radioligand therapy market was valued at USD 2.98 billion in 2025 and is forecast to reach USD 15.85 billion by 2035, an 18.2% CAGR. - Novartis received expanded FDA approval in 2026 for Pluvicto in earlier-line metastatic castration-resistant prostate cancer, moving PSMA therapy ahead of chemotherapy. - Eli Lilly advanced 177Lu-PNT2002 into a pivotal Phase 3 trial in biochemically recurrent prostate cancer, while Convergent Therapeutics began Phase III testing of CONV01-alpha. - Alpha-emitter pipeline agents using actinium-225 and lead-212 are the fastest-growing product segment, projected at a 24.6% CAGR through 2035.
- Bayer reported Q2 2026 net sales of EUR 10.9 billion, up 2% year-over-year, with first-half sales reaching EUR 24.3 billion, up 3%. - Pharma sales were broadly flat, but Nubeqa and Kerendia together grew 66%, offsetting a sharp 27% decline in Eylea driven by biosimilar competition. - The anticoagulant asundexian received priority review in the U.S. and China, with launches targeted around end-2026 or early-2027. - First-half free cash flow was negative EUR 2.7 billion, weighed by roughly EUR 2.5 billion in litigation payouts, while a favorable U.S. Supreme Court ruling strengthened Bayer's litigation containment strategy.
- The late-stage chronic kidney disease therapeutics market, valued at $13.02 billion in 2025, is forecast to grow at a 9.88% CAGR to reach $25.20 billion by 2032. - The treatment landscape is shifting from isolated renal care toward integrated cardio-renal-metabolic strategies, with SGLT2 inhibitors and RAAS inhibition serving as established standards alongside emerging biologics and digital adherence solutions. - Dialysis organizations, hospitals, and value-based kidney care programs are increasingly shaping formulary adoption based on operational fit and economic viability rather than clinical data alone. - Key players including AstraZeneca, Novartis, Bayer, Amgen, and Johnson & Johnson are navigating a market where combination logic, treatment sequencing, and real-world evidence are becoming as critical as individual agent efficacy.
- Voyageur Pharmaceuticals has engaged Fluor Corporation to conduct dual feasibility studies for an iodine extraction facility in Oklahoma and an integrated contrast drug manufacturing plant. - The iodine project, developed in collaboration with Bayer AG, will use Voyageur's patent-pending Mueller process to extract high-purity iodine from oilfield brine. - Voyageur has budgeted US$2,350,000 for the Bayer-linked feasibility study, with both studies expected to complete in early 2027, enabling a potential construction decision that year. - The initiative aims to establish North America's first fully integrated "Earth-to-Bottle" contrast media platform, combining domestically sourced barium and iodine to reduce supply chain risks.
- Pediatric oncology possesses exceptional scientific expertise, clinicians, research networks, and pharmaceutical capabilities, but these components are not always connected where they could most influence drug development. - Development-readiness assessment, industry expertise, and targeted funding must enter the process much earlier, before years of academic research have already shaped a program's direction. - The goal should shift from generating more data to generating evidence that can materially change the next development decision, with lessons flowing back into translational research and future programs. - The challenge is not simply more promising science, but creating a development pathway where pediatric oncology research encounters the right expertise and resources early enough to make a difference.
- Viralgen, a leading AAV gene therapy CDMO, has partnered with Elaaj Bio to advance ELJ-101, an investigational gene therapy targeting CDKL5 Deficiency Disorder, a rare pediatric neurological condition. - The collaboration leverages Viralgen's AAV manufacturing expertise to support process development, scale-up manufacturing, and analytical characterization for the preclinical-stage program. - CDKL5 Deficiency Disorder is a severe developmental and epileptic encephalopathy characterized by early-onset seizures and significant neurodevelopmental impairment caused by CDKL5 gene alterations. - The teams plan to initiate the first clinical trial for ELJ-101 in early 2027, with current efforts focused on scaling manufacturing processes to support clinical development.
- AskBio has introduced its commercial manufacturing process to supply ametefgene parvec (AB-1005) for the REGENERATE-PD Phase II trial following FDA IND amendment approval. - The investigational gene therapy delivers GDNF protein to the brain via adeno-associated viral vector to potentially slow Parkinson's disease progression and improve motor outcomes. - REGENERATE-PD is enrolling 127 participants aged 45-75 with moderate-stage Parkinson's disease across sites in Germany, Poland, the United Kingdom, and the United States. - The therapy has received multiple regulatory designations including FDA Fast Track, RMAT designation, and Japan's SAKIGAKE status for Parkinson's disease treatment.
