BioNTech SE

53 total trials 19 currently recruiting 19 completed

BioNTech SE sponsors 53 registered US clinical trials on ClinicalTrials.gov, 19 of them currently recruiting, and 19 completed. 12 of these trials are in Phase 3-4 (later-stage) and 40 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is COVID-19, with 8 trials.

Trial Pipeline

53 total, page 1 of 2

RECRUITING Phase 3

A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

NCT07365995

RECRUITING Phase 1

A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV

NCT07392372

RECRUITING Phase 3

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

NCT07300839

RECRUITING Phase 1

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 CA19-9

NCT07186842

RECRUITING Phase 3

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

NCT07173751

RECRUITING Phase 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)

NCT07111520

RECRUITING Phase 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 Tumors

NCT07070232

RECRUITING Phase 1

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

NCT07079631

RECRUITING Phase 3

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

NCT06340568

RECRUITING Phase 1

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

NCT06892548

RECRUITING Phase 1

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 Cancer

NCT06827236

RECRUITING Phase 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 Treatment

NCT06841055

RECRUITING Phase 3

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

NCT06712355

RECRUITING Phase 1

Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

NCT06750185

RECRUITING Phase 2

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

NCT06712316

RECRUITING Phase 2

A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

NCT05543616

RECRUITING Phase 1

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

NCT05142189

RECRUITING Phase 2

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 Cancer

NCT04486378

RECRUITING Phase 2

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-L1

NCT04534205

ACTIVE NOT RECRUITING Phase 3

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-19

NCT07222384

ACTIVE NOT RECRUITING Phase 3

A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years

NCT07069309

ACTIVE NOT RECRUITING Phase 2

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

NCT06449222

ACTIVE NOT RECRUITING Phase 2

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

NCT06449209

ACTIVE NOT RECRUITING Phase 1

Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

NCT06150183

ACTIVE NOT RECRUITING Phase 1

A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

NCT06069544

ACTIVE NOT RECRUITING Phase 1

A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines

NCT05988203

ACTIVE NOT RECRUITING Phase 1

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 Lesions

NCT05432583

ACTIVE NOT RECRUITING

Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

NCT04813627

COMPLETED Phase 1

A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

NCT06821061

COMPLETED Phase 1

A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

NCT06683352

COMPLETED Phase 1

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 Vaginosis

NCT06469164

TERMINATED Phase 1

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

NCT06069778

COMPLETED Phase 3

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

NCT06178991

COMPLETED Phase 2

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

NCT05997290

COMPLETED Phase 1

Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

NCT05581641

COMPLETED Phase 1

Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People

NCT05541861

COMPLETED Phase 2

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza

NCT05596734

COMPLETED Phase 2

A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

NCT05472038

TERMINATED Phase 1

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors

NCT05262530

TERMINATED Phase 1

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors

NCT04683939

COMPLETED Phase 2

Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

NCT04895982

COMPLETED Phase 2

Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants

NCT05004181

COMPLETED Phase 3

To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

NCT04955626

COMPLETED Phase 1

Dose Escalation Trial of BNT152+153 in Patients With Cancer

NCT04710043

COMPLETED Phase 2

A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment

NCT04526899

COMPLETED Phase 3

A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

NCT04816669

COMPLETED Phase 3

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

NCT04816643

COMPLETED Phase 2

To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

NCT04754594

COMPLETED Phase 3

A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

NCT04713553

TERMINATED Phase 1

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors

NCT04455620

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What the Pipeline for BioNTech SE Shows

According to the ClinicalTrials.gov registry, BioNTech SE is linked to 53 US clinical trials across every stage of research activity. Of those, 19 studies are currently recruiting, about 36% of the sponsor's indexed portfolio, and 19 are already marked complete, representing roughly 36% of the total.

The phase mix for BioNTech SE reports 12 late-stage studies (Phase 3 and Phase 4 combined) and 40 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for BioNTech SE is COVID-19 with 8 linked trials, and 9 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.