Sponsor · clinical trials

BioNTech clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine and the EU Clinical Trials Information System (CTIS) — current trials in our USA, Australia, UK, Spain, China, Germany, Turkey, Italy, Poland, Belgium, South Korea, France, Canada, Japan, Brazil, Taiwan, Israel, Netherlands, Czechia, Sweden, Denmark, Austria, Singapore, Mexico, Norway, Portugal, Switzerland and EU (CTIS) registers with BioNTech as lead sponsor. Synced 11 Nov 2026

30Current trials

22Recruiting now

30Drugs in these trials

28Trial registers

Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany

Compiled from ClinicalTrials.gov and CTIS registry records · Synced 11 Nov 2026 · Editorial standards

At a glance

BioNTech is the lead sponsor of 30 current clinical trials in our USA, Australia, UK, Spain, China, Germany, Turkey, Italy, Poland, Belgium, South Korea, France, Canada, Japan, Brazil, Taiwan, Israel, Netherlands, Czechia, Sweden, Denmark, Austria, Singapore, Mexico, Norway, Portugal, Switzerland and EU (CTIS) registers. 22 are recruiting patients now. The most common phase is Phase 1/2. The drugs named most often in its trials are Pumitamig, Carboplatin and Paclitaxel. The most-studied condition is Non-small Cell Lung Cancer.

Company profile on this site (news, sites, medicines, approvals): BioNTech SE (DE) →

ClinicalTrials.gov trials by status

Recruiting2279%
Active, closed621%

Trials by phase

Phase 1/2932%
Phase 2621%
Phase 3518%
Phase 1518%
Phase 2/327%
Phase 414%

Clinical trials sponsored by BioNTech

28 on ClinicalTrials.gov

Study	Phase	Status	Start	Registers
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer NCT06340568 · Endometrial Cancer Drugs: Docetaxel, Doxorubicin, Paclitaxel	Phase 3	Recruiting	2025-06	UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Poland, Austria, Czechia, Norway, Turkey, Canada, Brazil, South Korea, Taiwan, Singapore, Australia, Israel
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 · Non-small Cell Lung Cancer Drugs: BNT326, Pumitamig	Phase 1/2	Recruiting	2025-09	UK, USA, China, Germany, Spain, Italy, Poland, Turkey, Australia
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer NCT06712355 · Extensive-stage Small-cell Lung Cancer Drugs: Atezolizumab, Carboplatin, Etoposide	Phase 3	Recruiting	2025-02	UK, USA, China, Germany, France, Spain, Italy, Netherlands, Poland, Turkey, Japan, South Korea, Australia, Israel
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer NCT07365995 · Metastatic Castration-resistant Prostate Cancer Drugs: BNT324, Docetaxel, Prednisone/Prednisolone	Phase 3	Recruiting	2026-04	UK, USA, China, Germany, Belgium, Poland, Australia
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 · Non-Small Cell Lung Cancer Drugs: BNT116, Carboplatin, Cemiplimab	Phase 1	Recruiting	2022-06	UK, USA, Germany, Spain, Poland, Turkey, Australia
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 · Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer Drug: Pumitamig	Phase 1/2	Recruiting	2025-04	UK, USA, China, France, Spain, Italy, Turkey, Canada, Australia, Israel
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors NCT07455734 · ClinicalTrials.gov ↗ · Advanced Solid Tumor Cancer	Phase 1/2	Recruiting	2026-03	China, South Korea, Taiwan, Australia
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 NCT07079631 · Metastatic Colorectal Cancer Drugs: Bevacizumab, BNT314, Pumitamig	Phase 1/2	Recruiting	2025-07	UK, USA, Germany, Spain, Japan
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV NCT07392372 · HIV -1 Infection	Phase 1	Recruiting	2026-02	USA, Germany
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer NCT07173751 · Breast Neoplasms Drugs: Carboplatin, Eribulin, Gemcitabine	Phase 3	Recruiting	2025-10	UK, USA, China, Germany, Spain, Italy, Netherlands, Belgium, Poland, Czechia, Canada, Brazil, Mexico, Japan, South Korea, Singapore, Australia
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02) NCT06712316 · Non-small Cell Lung Cancer Drugs: Carboplatin, Paclitaxel, Pembrolizumab	Phase 2/3	Recruiting	2025-01	UK, USA, China, Germany, France, Spain, Italy, Belgium, Poland, Switzerland, Turkey, Brazil, Japan, South Korea, Australia
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors NCT07147348 · ClinicalTrials.gov ↗ · Advanced Solid Tumor Drug: Pumitamig	Phase 1/2	Recruiting	2025-08	China, Australia
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 · Non-small Cell Lung Cancer Drugs: Docetaxel, Pumitamig	Phase 2	Recruiting	2025-03	UK, USA, Spain, Turkey, South Korea, Australia
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 · Advanced Solid Cancers	Phase 1/2	Recruiting	2025-11	UK, USA, Germany, Spain, Australia
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 · Advanced Lung Cancer Drugs: BNT324, Pumitamig	Phase 1/2	Recruiting	2025-05	UK, USA, China, France, Spain, Italy, Poland, Turkey, Taiwan, Australia
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 · Advanced Solid Tumor Drugs: BNT326, Itraconazole, Paroxetine	Phase 1/2	Recruiting	2025-08	UK, USA, China, Germany, Spain, Italy, Belgium, Turkey, Australia
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 Cancer NCT07255404 · ClinicalTrials.gov ↗ · Pancreatic Ductal Adenocarcinoma (PDAC) Drugs: Gemcitabine, MFOLFIRINOX, Nab-paclitaxel	Phase 2	Recruiting	2025-12	China, Australia
A Study of COVID-19 Vaccine(s) in Children and Adults NCT07798648 · COVID-19 Vaccines Drug: Comirnaty	Phase 3	Recruiting	2026-08	USA
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors NCT06750185 · Advanced Solid Tumor	Phase 1/2	Recruiting	2025-01	USA, Australia
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age NCT07730450 · COVID-19 Vaccines Drug: Tdap Vaccine	Phase 4	Recruiting	2026-07	USA
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV NCT07698600 · HIV -1 Infection	Phase 1	Recruiting	2026-08	USA
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma NCT07297212 · ClinicalTrials.gov ↗ · Recurrent Glioblastoma Drugs: Bevacizumab, Pumitamig, Temozolomide	Phase 2	Recruiting	2026-01	China
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy NCT06449222 · Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers Drugs: Carboplatin, Eribulin, Gemcitabine	Phase 2	Active, closed	2024-08	UK, USA, Turkey, Australia
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 · Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer Drug: Pembrolizumab	Phase 2/3	Active, closed	2021-01	UK, USA, Germany, France, Spain, Italy, Belgium, Poland, Austria, Czechia, Portugal, Canada, Brazil, Mexico, South Korea, Taiwan, Australia, Israel
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 · Genital Herpes Simplex Type 2	Phase 1	Active, closed	2022-12	USA
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 · Colorectal Cancer Stage II, Colorectal Cancer Stage III Drug: Autogene cevumeran	Phase 2	Active, closed	2021-03	UK, USA, Germany, Spain, Belgium, Sweden, Canada
Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors NCT06150183 · Advanced Malignant Solid Tumor Drug: BNT314	Phase 1	Active, closed	2023-11	UK, USA, Spain, Belgium, Denmark, Japan
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy NCT06449209 · Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer Drugs: Carboplatin, Etoposide, Paclitaxel	Phase 2	Active, closed	2024-08	UK, USA, Turkey, South Korea, Australia

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

BioNTech in the EU trials register (CTIS)

2 trials

Authorised or ongoing trials in the EU Clinical Trials Information System with BioNTech as sponsor. Some are the same study as a ClinicalTrials.gov record above; the two registries share no common ID. Trials with a site in Ireland are listed first.

Study	Phase	Status	Countries
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer 2025-524445-27-00 · Male Urogenital Diseases Drugs: BNT324, Docetaxel, Prednisone	Phase 3	Ongoing	Belgium, Spain, Italy + 3 more
A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease 2025-521884-12-00 · CTIS ↗ · Neoplasms Drugs: Carboplatin, Eribulin, Gemcitabine	Phase 3	Ongoing	Czechia, Poland, Italy + 5 more

Drugs in BioNTech trials

30 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

Conditions in BioNTech trials

28 conditions

Non-small Cell Lung Cancer3 Advanced Solid Tumor3Locally Advanced Breast Cancer2Extensive-stage Small-cell Lung Cancer2 HIV -1 Infection2COVID-19 Vaccines2Metastatic Castration-resistant Prostate Cancer1 Non-Small Cell Lung Cancer1 Endometrial Cancer1Unresectable Breast Carcinoma1Metastatic Breast Cancer1 Triple Negative Breast Cancer1Metastatic Triple Negative Breast Cancers1Colorectal Cancer Stage II1Colorectal Cancer Stage III1Unresectable Head and Neck Squamous Cell Carcinoma1Metastatic Head and Neck Cancer1Recurrent Head and Neck Cancer1Advanced Solid Cancers1Advanced Lung Cancer1 Advanced Malignant Solid Tumor1 Breast Neoplasms1 Metastatic Colorectal Cancer1 Small-cell Lung Cancer1

By trial register

Register	Trials	Recruiting
Clinical trials in USA	24	18
Clinical trials in Australia	19	16
Clinical trials in UK	18	13
Clinical trials in Spain	15	12
Clinical trials in China	13	13
Clinical trials in Germany	13	11
Clinical trials in Turkey	11	9
Clinical trials in Italy	9	8
Clinical trials in Poland	9	8
Clinical trials in Belgium	8	5
Clinical trials in South Korea	8	6
Clinical trials in France	6	5
Clinical trials in Canada	5	3
Clinical trials in Japan	5	4
Clinical trials in Brazil	4	3
Clinical trials in Taiwan	4	3
Clinical trials in Israel	4	3
Clinical trials in Netherlands	3	3
Clinical trials in Czechia	3	2
Clinical trials in Sweden	2	1
Clinical trials in Denmark	2	1
Clinical trials in Austria	2	1
Clinical trials in Singapore	2	2
Clinical trials in Mexico	2	1
Clinical trials in Norway	1	1
Clinical trials in Portugal	1	0
Clinical trials in Switzerland	1	1
EU register (CTIS)	2	—

A trial with sites in more than one country appears in each of those registers.

Other sponsors in Non-small Cell Lung Cancer

Sponsor	Trials
AstraZeneca	15
Sichuan Baili Pharmaceutical	15
Merck Sharp & Dohme	10
Hoffmann-La Roche	6
Daiichi Sankyo	6
Shanghai Chest Hospital	5
Hunan Province Tumor Hospital	4
Shanghai Pulmonary Hospital, Shanghai, China	4
Regeneron Pharmaceuticals	3
Abbisko Therapeutics	3

Sponsors with the most current trials registered for this condition.

Questions about BioNTech trials

How many clinical trials does BioNTech sponsor?

BioNTech is the lead sponsor of 28 current trials on ClinicalTrials.gov in our USA, Australia, UK, Spain, China, Germany, Turkey, Italy, Poland, Belgium, South Korea, France, Canada, Japan, Brazil, Taiwan, Israel, Netherlands, Czechia, Sweden, Denmark, Austria, Singapore, Mexico, Norway, Portugal and Switzerland registers, and 2 authorised or ongoing trials in the EU register (CTIS), as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.

Are BioNTech trials recruiting?

Yes. 22 of its 28 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is BioNTech testing?

Its current trials name 30 drugs and biologicals as interventions. The most frequent are Pumitamig (14), Carboplatin (7), Paclitaxel (6), Docetaxel (5) and Gemcitabine (4). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, lead sponsor, phase, overall status, start date, conditions and intervention names
EU Clinical Trials Information System (CTIS) ↗ EU trial numbers, titles, sponsor, phase, status, therapeutic area and member-state countries

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.