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Bayer
Bayer owns Xofigo, the only approved alpha emitter, and is developing next-generation actinium PSMA agents.
Overview
Bayer, based in Leverkusen and listed as BAYN.DE, owns Xofigo, or radium-223, the only approved alpha emitter, and is developing next-generation actinium-225 PSMA agents. Its oncology portfolio includes 225Ac-PSMA-Trillium, also known as BAY 3563254, darolutamide in prostate cancer, sevabertinib for HER2-mutant non-small-cell lung cancer approved in 2025, larotrectinib, developed earlier with Lilly, and copanlisib, with the AlphaBreak and AcTION actinium trials linked in OnCo. OnCo also connects it to colorectal, liver, GIST and desmoid tumour pages, to the Norwegian Radium Hospital in Oslo, and to its venture arm Leaps by Bayer. Whether a targeted alpha emitter can go further than radium-223 did is the open question its PSMA programme will answer. Actinium-225 PSMA agents have their own page.
Headquarters
Leverkusen, DE
Scorecard
All companies#18of 1244 companies, score 105
- approved products +36
- phase 3 +3
- targets +20
- modalities +6
- regions +8
- 24-month regulatory events +8
- registry trials +30
- failures -6
6 approved, 1 in phase 3, 0 earlier, 10 targets, 1,026 registry studies. Formula on the scorecards page.
Type
Large pharma · BAYN.DE
Stage
Public
Website
Phase 3Targeted alpha therapy
Alpha-emitting PSMA drugs that produce responses even after Pluvicto fails, held back mainly by isotope supply.
NegativeAntibody-drug conjugate (anti-mesothelin antibody, DM4 payload), intravenous
Anetumab ravtansine was the first antibody-drug conjugate tested in a randomised trial in mesothelioma, aimed at the mesothelin protein that nearly all mesotheliomas carry; it was no better than vinorelbine chemotherapy as second-line treatment, and is now being tried with pembrolizumab.
WithdrawnIntravenous pan-class I PI3K inhibitor (α/δ predominant)
Copanlisib · Aliqopa
Copanlisib is an intravenous PI3K inhibitor for relapsed follicular lymphoma, approved in 2017 and withdrawn in 2023 when its confirmatory trial failed.
ApprovedSmall-molecule AR antagonist
Darolutamide · Nubeqa
Darolutamide is an AR blocker that barely enters the brain, so it causes fewer falls and cognitive side effects; it is approved with and without chemotherapy.
ApprovedSmall-molecule pan-TRK inhibitor (first generation)
Larotrectinib · Vitrakvi
The first drug approved for a gene fusion regardless of where the cancer started; it works in about 75% of NTRK-fusion cancers, from infant fibrosarcoma to salivary and thyroid cancers.
ApprovedTargeted alpha therapy (bone-seeking)
Radium-223 dichloride · Xofigo
Radium-223 was the first alpha-emitting drug ever approved (2013). It homes to bone like calcium and treats prostate cancer that has spread only to bone.
ApprovedSmall-molecule multi-kinase inhibitor
Regorafenib · Stivarga
A sorafenib successor that became the first second-line drug proven to prolong life in liver cancer (2017).
ApprovedSmall-molecule kinase inhibitor (HER2)
Sevabertinib · Hyrnuo
Sevabertinib is an oral HER2 inhibitor for lung cancers with HER2 mutations, approved in November 2025 as an alternative to Enhertu and zongertinib.
ApprovedSmall-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF)
Sorafenib · Nexavar
The first drug ever to extend life in advanced liver cancer (2007), now mostly a comparator arm that newer combinations are measured against.
Similar pages
- TermProstate cancer drugs in England: what NICE recommends, and what it refuses
- TechnologyAndrogen deprivation & AR pathway inhibitors
Shares Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer, A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer, A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have Hi, ARANOTE.
- TechnologyTargeted alpha therapy
Shares AlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617), ALSYMPCA, ERA 223, Actinium-225 PSMA agents.
- TargetNTRK
Shares NAVIGATE, NTRK fusion-positive non-small-cell lung cancer, Larotrectinib, Salivary gland cancers.
- PersonKarim Fizazi
Shares ARAMIS, ALSYMPCA, Radium-223 dichloride, Prostate cancer.
- TargetVEGF / VEGFR
Shares CONCUR, DECISION, CORRECT, Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT).
- TermBone metastases and skeletal-related events
Shares ERA 223, PEACE-3 (EORTC 1333), Radium-223 dichloride, Prostate cancer.
- TermWhat follows what in castration-resistant prostate cancer
Shares ALSYMPCA, PEACE-3 (EORTC 1333), Radium-223 dichloride, Prostate cancer.
cancers
fronts
technologies
drugs
Phase 3Targeted alpha therapy
NegativeAntibody-drug conjugate (anti-mesothelin antibody, DM4 payload), intravenous
WithdrawnIntravenous pan-class I PI3K inhibitor (α/δ predominant)
Copanlisib · Aliqopa
ApprovedSmall-molecule AR antagonist
Darolutamide · Nubeqa
ApprovedSmall-molecule pan-TRK inhibitor (first generation)
Larotrectinib · Vitrakvi
ApprovedTargeted alpha therapy (bone-seeking)
Radium-223 dichloride · Xofigo
ApprovedSmall-molecule multi-kinase inhibitor
Regorafenib · Stivarga
ApprovedSmall-molecule kinase inhibitor (HER2)
Sevabertinib · Hyrnuo
ApprovedSmall-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF)
Sorafenib · Nexavar
companies
institutions
terms
trials
A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer StudiesA Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid TumorsA Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate CancerA Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or RectumA Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have HiA Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerA Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-smaA Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in ChildrenAlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617)ALSYMPCAAnetumab ravtansine versus vinorelbine in relapsed mesothelin-positive pleural mesotheliomaARAMISARANOTEARASENSCONCURCORRECTDECISIONERA 223GRIDNAVIGATEPEACE-3 (EORTC 1333)REGOBONERegorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual DiRESORCESHARPSOHO-01Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by BayerTAPUR (Targeted Agent and Profiling Utilization Registry)
key papers
Open-source projects
All open source in oncology →Open-source projects that this organisation maintains, from OnCo's own catalogue: licence and last activity as the repository reported them on the day of the fetch. Listing is not endorsement; check the licence before reuse and the validation before clinical use.
Bayer's Python interface to QuPath projects and annotations.