Our grouping. This page groups the registry's lead sponsor names by company — our grouping, not the registry's. It can be wrong or incomplete: an acquired company whose name never mentions its owner may be missing. Use “Something wrong?” under any name below to correct it.
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BioNTech SE clinical trials
The registry lists 124 studies whose lead sponsor is BioNTech SE or one of 6 companies grouped under it. 33 are recruiting or about to start. Per ClinicalTrials.gov, last updated Oct 23, 2026.
Keep track of what changes. Save the BioNTech SE studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesRegistry sponsor names on this page
Each name exactly as ClinicalTrials.gov lists it, and how it relates to BioNTech SE.
- BioNTech SE76 studiesSame company
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- 18 studies →
- 18 studies →
- BioNTech US Inc.4 studiesSame company
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- BioNTech Research & Development, Inc.3 studies →Subsidiary
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- BioNTech RNA Pharmaceuticals GmbH2 studies →Subsidiary
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- BioNTech Diagnostics GmbH2 studies →Subsidiary
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- BioNTech Cell & Gene Therapies GmbH1 study →Subsidiary
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Focus areas
Conditions BioNTech SE leads ten or more studies in, by study count. A broader condition is left out when almost all its studies are already in a narrower one listed here.
Studies
Recruiting first, then most recently updated. Showing 50 of 124. Browse all 124 →
- A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational DrugsNot yet recruitingNCT07893054Phase 1
- A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)RecruitingNCT07111520Phase 1/2
- A Clinical Trial to Test if the Investigational Drug BNT3210 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker Sialyl-TnNot yet recruitingNCT07886684Phase 1/2
- ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast CancerRecruitingNCT07173751Phase 3
- A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine CancerRecruitingNCT06340568Phase 3
- A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate CancerRecruitingNCT07365995Phase 3
- Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)RecruitingNCT06712316Phase 2/3
- A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast CancerRecruitingNCT06827236Phase 1/2
- A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9RecruitingNCT07186842Phase 1/2
- Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung CancerRecruitingNCT06712355Phase 3
- A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIVRecruitingNCT07698600Phase 1
- A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant TumorsRecruitingNCT07070232Phase 1/2
- A Study of COVID-19 Vaccine(s) in Children and AdultsRecruitingNCT07798648Phase 3
- Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsRecruitingNCT06750185Phase 1/2
- A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIVRecruitingNCT07392372Phase 1
- A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung CancerRecruitingNCT06892548Phase 1/2
- Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid TumorsRecruitingNCT07455734Phase 1/2
- A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in AfricaRecruitingNCT07379580Phase 2
- A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of AgeRecruitingNCT07730450Phase 4
- A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic CancerRecruitingNCT07255404Phase 2
- PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal CancerRecruitingNCT07133750Phase 2
Sponsor listed in the registry: Biotheus Inc. · First submitted after Biotheus Inc. became part of BioNTech SE
- Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung CancerRecruitingNCT05142189Phase 1
- A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal CancerRecruitingNCT07079631Phase 1/2
- A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid TumorsRecruitingNCT07147348Phase 1/2
- A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent GlioblastomaRecruitingNCT07297212Phase 2
- Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line TreatmentRecruitingNCT06841055Phase 2
- A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCCNot yet recruitingNCT06584071Phase 1/2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- PM8002 in the Treatment of Patients With Advanced Solid TumorsRecruitingNCT05918445Phase 1/2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- A Study of PM1015 in Patients With Advanced Solid TumorsRecruitingNCT05950815Phase 1
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- A Study of PM1022 in Patients With Advanced TumorsRecruitingNCT05867771Phase 1/2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid TumorsRecruitingNCT05862831Phase 1/2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid TumorsRecruitingNCT05839106Phase 1/2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid TumoursNot yet recruitingNCT05537051Phase 1
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung CancerActive, not recruitingNCT06616532Phase 3
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes LesionsActive, not recruitingNCT05432583Phase 1
- A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of AgeCompletedNCT07300839Phase 3
- A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1Active, not recruitingNCT04534205Phase 2/3
- A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal CancerActive, not recruitingNCT04486378Phase 2
- A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial VaginosisCompletedNCT06469164Phase 1
- Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid TumorsActive, not recruitingNCT06150183Phase 1
- A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox VaccinesCompletedNCT05988203Phase 1/2
- Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With ChemotherapyActive, not recruitingNCT06449209Phase 2
- A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against MalariaCompletedNCT06069544Phase 1/2
- A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy PeopleCompletedNCT06683352Phase 1/2
- A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19CompletedNCT07222384Phase 3
- A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy ChildrenCompletedNCT05543616Phase 3
- PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBCActive, not recruitingNCT06419621Phase 3
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- A Study of PM8002 in Combination With Chemotherapy in Patients With NENActive, not recruitingNCT05879055Phase 2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular CarcinomaCompletedNCT05864105Phase 2
Sponsor listed in the registry: Biotheus Inc. · First submitted before Biotheus Inc. became part of BioNTech SE
- Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With ChemotherapyActive, not recruitingNCT06449222Phase 2