Pipeline — registered trials by phase
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
— · COVID-19 Vaccines · Recruiting · est. 2027-08-20
Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy
— · Breast Cancer · Completed · est. 2014-09
Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"
— · Invasive Breast Cancer · Completed · est. 2014-08
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2021-11-25
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
— · Colorectal Cancer Stage II, Colorectal Cancer Stage III · Completed · est. 2025-04-23
Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma
— · Melanoma · Completed · est. 2023-06-20
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects
— · SARS-CoV-2 · Completed · est. 2020-09-30
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
— · Solid Tumor · Active Not Recruiting · est. 2028-08
RBL001/RBL002 Phase I Clinical Trial
— · Melanoma · Completed · est. 2015-05
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
— · Genital Herpes Simplex Type 2 · Active Not Recruiting · est. 2026-10
Dose Escalation Trial of BNT152+153 in Patients With Cancer
— · Solid Tumor · Completed · est. 2025-09-10
A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer
— · Carcinoma, Non-Small-Cell Lung, Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung · Completed · est. 2019-10-31
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
— · Non-Small Cell Lung Cancer · Recruiting · est. 2030-02
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
— · Bacterial Vaginosis · Completed · est. 2025-07-31
A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer
— · Urinary Bladder Cancer, Bladder Tumors, Transitional Cell Carcinoma of the Bladder · Completed · est. 2019-02
RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID
— · Breast Cancer (Triple Negative Breast Cancer (TNBC)) · Completed · est. 2020-05-13
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
— · HIV -1 Infection · Recruiting · est. 2026-11
Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors
— · Advanced Malignant Solid Tumor · Active Not Recruiting · est. 2026-08-18
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
— · HIV -1 Infection · Recruiting · est. 2028-02
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
— · Tuberculosis · Completed · est. 2025-06-06
Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2024-11-22
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
— · Infections, Respiratory, Virus Diseases, Infection Viral · Completed · est. 2021-06-30
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
— · Influenza,Human, COVID-19 · Completed · est. 2025-07-15
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
— · Colorectal Cancer Stage II, Colorectal Cancer Stage III · Active Not Recruiting · est. 2026-11
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)
— · Non-small Cell Lung Cancer · Recruiting · est. 2028-11
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
— · Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection · Recruiting · est. 2027-06
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
— · Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers · Active Not Recruiting · est. 2028-08
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population
— · SARS-CoV-2 · Completed · est. 2021-02-07
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
— · Covid-19, Protection Against COVID-19 · Completed · est. 2021-03-12
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
— · SARS-CoV-2 Infection, COVID19 · Completed · est. 2023-07-23
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
— · Recurrent Glioblastoma · Recruiting · est. 2028-01
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
— · Malaria · Completed · est. 2025-05-28
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
— · Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma · Completed · est. 2024-01-25
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
— · Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer · Active Not Recruiting · est. 2027-06
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
— · Advanced Solid Tumor · Recruiting · est. 2028-03
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
— · Advanced Solid Tumor Cancer · Recruiting · est. 2030-10
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
— · Advanced Lung Cancer · Recruiting · est. 2028-09
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
— · Monkeypox · Completed · est. 2025-08-25
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 Cancer
— · Metastatic Colorectal Cancer · Recruiting · est. 2030-12
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
— · Non-small Cell Lung Cancer · Recruiting · est. 2028-10
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
— · Advanced Solid Cancers · Recruiting · est. 2030-05
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
— · SARS-CoV-2 Infection, COVID-19, SARS-CoV-2 Acute Respiratory Disease · Completed · est. 2023-08-16
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
— · Influenza, COVID-19 (Coronavirus Disease 2019) · Completed · est. 2025-12-17
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
— · Advanced Solid Tumor · Recruiting · est. 2031-04
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
— · Influenza, Human, COVID-19 · Completed · est. 2023-12-28
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
— · COVID-19, SARS-CoV-2 Infection · Completed · est. 2022-04-14
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
— · COVID-19, SARS-COV-2 Infection · Active Not Recruiting · est. 2026-07-31
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
— · COVID-19, SARS-COV-2 Infection · Completed · est. 2026-05-01
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
— · Breast Neoplasms · Recruiting · est. 2029-12
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
— · SARS-CoV-2 Infection, COVID-19, Maternal Immunization · Completed · est. 2022-07-15
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
— · Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer · Active Not Recruiting · est. 2028-08
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
— · Metastatic Castration-resistant Prostate Cancer · Recruiting · est. 2031-02
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
— · Endometrial Cancer · Recruiting · est. 2028-03
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2022-10-05
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2023-02-10
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
— · Non-small Cell Lung Cancer · Recruiting · est. 2029-01
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2023-05-25
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
— · COVID-19, SARS-COV-2 Infection · Completed · est. 2026-07-24
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
— · SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19 · Completed · est. 2026-07-10
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
— · Extensive-stage Small-cell Lung Cancer · Recruiting · est. 2028-12
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2024-03-26
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
— · SARS-CoV-2 Infection, COVID-19 · Completed · est. 2021-12-01
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
— · Influenza, COVID-19 · Completed · est. 2024-11-26
No approved products listed under this sponsor in Drugs@FDA (partnered or subsidiary products may be listed elsewhere).
Source: ClinicalTrials.gov (trials where BioNTech is lead sponsor; 65 active or completed) and Drugs@FDA (0 approved products). Registry data can include older or partnered programs; the company's own pipeline page is the official list.
SEC filings — insider trading forms excluded
- 6-K2026-09-18Report of foreign issuer
- 6-K2026-09-14Report of foreign issuer
- 6-K2026-08-28Report of foreign issuer
- 6-K2026-08-27Report of foreign issuer
- 6-K2026-08-20Report of foreign issuer
- 6-K2026-08-04Report of foreign issuer
- 6-K2026-08-04Report of foreign issuer
- 6-K2026-08-03Report of foreign issuer
- 20-F/A2026-07-3020-F/A
- 6-K2026-07-29Report of foreign issuer
- 6-K2026-06-08Report of foreign issuer
- 6-K2026-06-01Report of foreign issuer
- 6-K2026-05-22Report of foreign issuer
- 6-K2026-05-15Report of foreign issuer
- SCHEDULE 13G/A2026-05-15SCHEDULE 13G/A
- SCHEDULE 13G/A2026-05-14SCHEDULE 13G/A
- 6-K2026-05-07Report of foreign issuer
- 6-K2026-05-05Report of foreign issuer
- 6-K2026-05-05Report of foreign issuer
- 6-K2026-04-13Report of foreign issuer
- 6-K2026-04-02Report of foreign issuer
- 20-F/A2026-04-0120-F/A
- 6-K2026-03-24Report of foreign issuer
- 20-F2026-03-10Annual report (foreign)
- 6-K2026-03-10Report of foreign issuer
- 6-K2026-03-10Report of foreign issuer
- 6-K2026-01-28Report of foreign issuer
- 6-K2026-01-14Report of foreign issuer
- 6-K2026-01-12Report of foreign issuer
- 6-K2026-01-06Report of foreign issuer
- SC TO-T/A2025-12-18SC TO-T/A
- 6-K2025-12-18Report of foreign issuer
- 6-K2025-12-09Report of foreign issuer
- 6-K2025-12-08Report of foreign issuer
- SC TO-T/A2025-12-03SC TO-T/A
- 4252025-12-03425
- 6-K2025-12-03Report of foreign issuer
- SC TO-T/A2025-11-26SC TO-T/A
- 4252025-11-26425
- 6-K2025-11-26Report of foreign issuer
Source: SEC EDGAR. Forms 3/4/5 and 144 (insider transactions) are intentionally left out.