First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) (PAnTHA)

A Phase 1 Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of 225Ac-PSMA-Trillium in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

Researchers are looking for a better way to treat participants who have metastatic castration-resistant prostate cancer (mCRPC).

mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment used to lower the level of testosterone, a male sex hormone, to prevent cancer from growing.

The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It works by binding to PSMA and giving off radiation that can damage cancer cells and stop them from growing.

The main purpose of this first-in-human study is to learn:

• How safe is BAY3563254 in participants.
• What is the recommended dose of BAY3563254 that is safe and works well that will be further tested in Part 2 of the study.
• How well does BAY3563254 work in participants.

To answer this, the researchers will look at:

• The number and severity of medical problems including serious medical problems that participants experience after taking BAY3563254
• The number of dose-limiting toxicities (DLT) at each dose level. A DLT is a medical problem caused by a drug that is too severe to continue the use of that specific dose.
• The number of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR))
• The number of participants who have a decrease in the levels of PSA* by at least 50% in their blood (also known as PSA50). PSA is a protein made by the prostate gland. High levels of PSA may indicate the presence of prostate cancer.
• Participants' best response to treatment based on their PSA levels (also known as the best overall PSA response).

The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose of BAY3563254 for use in the second part of the study. For this, each participant will receive one of different increasing amounts of BAY3563254. They will take BAY3563254 as an injection into a vein. All participants in the second part of the study, called dose expansion, will receive the most appropriate dose of BAY3563254 that was identified from the first part of the study.

Participants in this study will take the study treatment once every 6 or 8 weeks, which is known as a treatment cycle. Each participant will have up to 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for approximately 6 years, including a screening phase of up to 30 days, 6 months of treatment depending on the participant's benefit, and a follow up phase of 60 months after the end of treatment.

In addition, substudies performed during both dose escalation and dose expansion parts of the study will evaluate:

• the clearance of radioactivity from the body over time
• the doses of radiation that are delivered to normal organs and tumors

During the study, the doctors and their study team will:

• take blood and urine samples
• check vital signs such as blood pressure, heart rate, and body temperature
• examine heart health using electrocardiogram (ECG)
• take tumor samples if required
• check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and bone scan
• check the tumor status using PET (positron emission tomography)
• check the amount of radiation absorbed by tumors and normal organs using SPECT/CT (single-photon emission tomography and computed tomography scan)
• ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

The treatment period ends with a visit in 6-12 weeks after the last BAY3563254 dose. About 6-12 weeks after the last dose and every 6 weeks thereafter, the study doctors and their team will check the participants' health and any changes in their cancer. This active follow-up period ends after 18 months. The long-term follow-up period will start after the end of the active follow-up visit and will continue for up to 60 months after the the last BAY3563254 dose. Participants will be contacted, typically by phone call or clinic visit, approximately every 12 weeks after the end of active follow-up.

Study Overview

• Status: Recruiting
• Conditions: Advanced Metastatic Castration-resistant Prostate Cancer; Prostate Specific Membrane Antigen (PSMA) Expression
• Intervention / Treatment: Drug: 225Ac-PSMA-Trillium (BAY3563254)

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet / Nuclear Medicine
  • Kortrijk, Belgium, 8500
    • Recruiting
    • AZ Groeninge Campus Kennedylaan - Urology
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • UZ Leuven - Campus Gasthuisberg - Nuclear Medicine
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Withdrawn
      • Cross Cancer Institute | Clinical Trials Unit
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • BC Cancer | Vancouver
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre | Clinical Trials
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM) | Oncology
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology
• Finland
  • Northern Savonia
    • Kuopio, Northern Savonia, Finland, 70210
      • Recruiting
      • Kuopio University Hospital, Kuopion yliopistollinen sairaala (KYS) - Syövänhoitokeskus
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Suspended
      • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Syöpäkeskus
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20540
      • Recruiting
      • Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Syöpäkeskus
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00180
      • Not yet recruiting
      • Docrates Mehiläinen Syöpäsairaala
    • Helsinki, Uusimaa, Finland, 00029
      • Recruiting
      • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Syöpäkeskus
• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia s.r.l - Medicina Nucleare
  • Naples, Italy, 80131
    • Not yet recruiting
    • IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Medicina Nucleare e Terapia Metabolica
• Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Not yet recruiting
      • Yokohama City University Hospital
  • Tokyo
    • Koto-ku, Tokyo, Japan, 135-8550
      • Not yet recruiting
      • The Cancer Institute Hospital Of JFCR
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Withdrawn
      • Erasmus Medisch Centrum
• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 221 85
      • Recruiting
      • Skånes Universitetssjukhus Lund - Onkologens kliniska forskningsenhet
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 76
      • Recruiting
      • Karolinska Universitetssjukhuset - Fas I-enheten Solna CKC
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 751 85
      • Suspended
      • Akademiska sjukhuset i Uppsala - Fas 1-enheten
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 46
      • Recruiting
      • Sahlgrenska Universitetssjukhuset - Klinisk prövningsenhet Fas I/FIH
• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • Univestitätsspital Zürich (USZ)
  • Canton of Aargau
    • Baden, Canton of Aargau, Switzerland, 5404
      • Withdrawn
      • Kantonsspital Baden
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4056
      • Not yet recruiting
      • Universitätsspital Basel
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, W1T 7HA
      • Recruiting
      • University College London Hospitals NHS Foundation Trust | University College Hospital - NIHR UCLH Clinical Research Facility
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Active, not recruiting
      • The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
      • Not yet recruiting
      • The Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Cancer Trials Research Centre
• United States
  • California
    • Duarte, California, United States, 91010
      • Not yet recruiting
      • City of Hope - Duarte Cancer Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Not yet recruiting
      • M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Not yet recruiting
      • XCancer Omaha
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • The University of Texas MD Anderson Cancer Center - Texas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• mCRPC with pathological confirmation of adenocarcinoma without small-cell or neuroendocrine features.
• Previous treatment with at least 1 novel androgen axis drug (NAAD) (e.g., enzalutamide, apalutamide, darolutamide and/or abiraterone).
• Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).

• Prior taxane treatment:

  • Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician
  • Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane regimens, in the castration-resistant setting

• Dose Expansion Group B: Participants must not have received any taxane regimens since becoming castration-resistant

  • Dose Expansion Group C: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician
• Prior treatment with an established Lu-PSMA therapy (i.e., dose activity and cycles comparable to approved treatments) is required for participants in Dose Expansion Group C only. More specifically, to qualify for this expansion group, participants must not have discontinued 177Lu-PSMA treatment due to intolerance.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

• Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements within 30 days before start of study intervention, as indicated below. Note that blood transfusions (red blood cells or platelets) and administration of G-CSF or GM-CSF are prohibited within 21 days prior to screening for the below bone marrow-related parameters.

  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) ≥1500/mm^3
  • Platelet count ≥100,000/mm^3
  • Total bilirubin ≤1.5 x the Upper limit of normal (ULN), or ≤3×ULN if the participant has a confirmed history of Gilbert's syndrome (note that participants with Gilbert's syndrome should be carefully evaluated for other liver-related disorders that may impact their suitability for this study).
  • Alanine transaminase (ALT) and Aspartate transaminase (AST) ˂2.5 x ULN (≤5 x ULN for participants with liver involvement)
  • Participants on a stable dose of anticoagulation therapy are allowed to participate if they have no sign of bleeding or clotting, and prothrombin time international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) test results are acceptable at the Investigator's discretion
  • Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula and serum creatinine ≤1.5 x ULN
• Participants must have at least one PSMA-positive (prostate-specific membrane antigen) distant metastatic lesion on the screening PSMA PET/CT scan using the study-designated PSMA PET tracers, as determined by the site Investigator. For eligibility purposes, a PSMA-positive lesion must have activity greater than the liver by visual assessment of the screening PSMA PET/CT. A PSMA-positive metastatic lesion should not correspond to a normal tissue structure or benign lesion.

• Documented progressive mCRPC per PCWG3, and a minimum starting PSA value of 2.0 ng/mL is mandatory. Progressive mCRPC is defined as meeting at least one of the following criteria:

  1. PSA progression (defined as 2 consecutive increases over a previous reference value obtained at a minimum of 1-week
  2. Radiological progression in soft-tissue lesions according to PCWG3 modification of RECIST v1.1 criteria
  3. Progression of bone disease (defined as ≥ 2 new bone lesions according to PCWG3 bone scan criteria)

Exclusion Criteria:

• Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the site Investigator. A PSMA-negative lesion for eligibility purposes must have activity equal to or less than the liver by visual assessment of the screening PSMA PET/CT scan using the study-designated PSMA PET/CT tracers. A PSMA-negative metastatic lesion should not correspond to a normal tissue structure or benign lesion.

  • a. Any single or multiple lymph node(s) ≥2.5 cm in the short axis.
  • b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis.
  • c. Any bone metastasis with a soft tissue component ≥ 1 cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous metastases without a soft tissue component do not exclude a participant.
  • d. Predominantly necrotic lesions with greater than 1 cm of enhancing tissue on contrast-enhanced computed tomography / magnetic resonance imaging (CT/MRI).
• Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study treatment, except luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH). Start of study treatment is allowed in shorter timeframes if 5 half-lives of the prior drug(s) have elapsed.
• Prior radiopharmaceutical treatment using actinium-225.

Other prior radiopharmaceutical treatments:

• Dose escalation and Dose expansion Groups A and B: Prior treatment with a radiopharmaceutical is prohibited, with the exception of prior treatment with radium-223 dichloride more than 3 months before the start of study intervention. Note: Participants who have discontinued radium-223 dichloride treatment due to intolerance are excluded from Groups A and B.

• Dose expansion Group C: Prior treatment with a radiopharmaceutical is prohibited with the following exceptions: Prior treatment with radium-223 dichloride more than 3 months before the start of study intervention is permitted; and prior treatment with 177Lu-PSMA more than 6 weeks before the start of study intervention is required. Note: Participants who have discontinued 177Lu-PSMA or radium-223 dichloride treatment due to intolerance are excluded from Group C.

  • Prior definitive therapy (radiotherapy or surgery) completed less than 6 weeks before the start of study intervention. Note that palliative radiotherapy completed less than 6 weeks before the start of study intervention will be allowed if: (i) no more than 10% of the participants' bone marrow is irradiated, (ii) it does not encompass all potential target/measurable lesions for participants in dose expansion.
  • Toxic effects of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 from prior anticancer therapy not yet stabilized or where significant post-treatment toxicities have been observed. Chronic toxic effects of CTCAE Grade ≤2 from prior anticancer therapy where no further resolution is expected do not require exclusion with agreement between the Investigator and Sponsor (e.g., chemotherapy-induced neuropathy, fatigue, alopecia, anorexia, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation of BAY3563254; Participants with advanced mCRPC will receive increased 225Ac-PSMA-Trillium doses in a planned stepwise fashion.	Drug: 225Ac-PSMA-Trillium (BAY3563254); Intravenous slow injection on Day 1 of a 6 week treatment cycle.
Experimental: 225Ac-PSMA-Trillium Imaging and Dosimetry; The 225Ac-PSMA-Trillium Imaging and Dosimetry Substudy will enroll throughout both dose escalation and dose expansion, starting with the first dose level in dose escalation. The substudy will generally be available at all study sites to participants in the main study.	Drug: 225Ac-PSMA-Trillium (BAY3563254); Intravenous slow injection on Day 1 of a 6 week treatment cycle.
Experimental: HPGe or NaI Whole Body Radioactivity Measurement of 225Ac-PSMA-Trillium; HPGe or NaI measurements of whole-body radioactivity of 225Ac and its daughters as a function of time will be conducted on an optional basis during dose escalation and dose expansion at selected sites to evaluate the clearance of total radioactivity from the body over time. Participants in the 111In-PSMA-Trillium and Tris-POC Imaging Substudy will not be eligible for this HPGe or NaI Whole Body Radioactivity Measurement of 225Ac-PSMA-Trillium Substudy.	Drug: 225Ac-PSMA-Trillium (BAY3563254); Intravenous slow injection on Day 1 of a 6 week treatment cycle.
Experimental: Dose expansion group A of BAY3563254; Participants with advanced mCRPC must have received at least 1 but no more than 2 prior taxane-based chemotherapy regimens. No prior treatment with 177Lu-PSMA.	Drug: 225Ac-PSMA-Trillium (BAY3563254); Intravenous slow injection on Day 1 of a 6 week treatment cycle.
Experimental: Dose expansion group B of BAY3563254; Participants with advanced mCRPC must *not* have received taxane-based chemotherapy since becoming castration resistant. No prior treatment with 177Lu-PSMA.	Drug: 225Ac-PSMA-Trillium (BAY3563254); Intravenous slow injection on Day 1 of a 6 week treatment cycle.
Experimental: Dose expansion group C of BAY3563254; Participants with advanced mCRPC treated with 225Ac-PSMA-Trillium, who have received treatment with an established 177Lu-PSMA therapy and who did not discontinue 177Lu-PSMA treatment due to intolerance.	Drug: 225Ac-PSMA-Trillium (BAY3563254); Intravenous slow injection on Day 1 of a 6 week treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation and Dose Expansion: Incidence of TEAEs (including TESAEs)	TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event	After the first administration of study intervention up to 42 days after the last dose of study intervention
Dose Escalation and Dose Expansion: Severity of TEAEs (including TESAEs)		After the first administration of study intervention up to 42 days after the last dose of study intervention
Dose Escalation: Incidence of DLTs	DLT: Dose-Limiting Toxicities	Up to and including Cycle 3 (each cycle is 42 days)
Dose Escalation and Dose Expansion: ORR by PCWG3 guideline based on Investigator review	ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per PCWG3 guidelines as assessed by the Investigator.	Up to 18 months after end of treatment
Dose Escalation and Dose Expansion: PSA50 response	PSA50 response is defined as a ≥50% decline in PSA value from baseline (Cycle 1 Day 1).	At 12 weeks or later (up to 18 months after end of treatment)
Dose Expansion: Best overall PSA response	Best overall PSA response corresponds to the maximum percentage decline or the minimum percentage increase (if no decline) in PSA value from baseline (Cycle 1 Day 1).	Up to 18 months after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Expansion: Recommended dose for further clinical development		Up to 18 months after end of treatment
Dose Expansion: Recommended dose regimen for further clinical development		Up to 18 months after end of treatment
Dose Escalation and Dose Expansion: Radiologic progression-free survival (rPFS) by PCWG3 based on Investigator review	rPFS is defined as the time from the start of study treatment to the date of first observed disease progression (Investigator's radiological assessment by PCWG3) or death due to any cause, if death occurs without progression is documented.	Up to 18 months after end of treatment
Dose Escalation and Dose Expansion: Duration of response (DOR) by PCWG3 based on Investigator review	DOR is defined as the time from the first documented objective response of PR or CR by PCWG3, whichever occurs earlier, to disease progression or death (if death occurs without progression is documented).	Up to 18 months after end of treatment
Dose Escalation and Dose Expansion: Duration of PSA50 response	Duration of PSA50 response is defined as the time from the first documented PSA50 response to PSA progression by PCWG3 or death (if death occurs without progression is documented).	Up to 18 months after end of treatment
Dose Escalation and Dose Expansion: Cmax of 225Ac		Cycle 1, cycle 2 (From pre-dose up to Day 36 post-dose for each cycle)
Dose Escalation and Dose Expansion: AUC and AUC(0-tlast) of 225Ac		Cycle 1, cycle 2 (From pre-dose up to Day 36 post-dose for each cycle)
Dose Escalation and Dose Expansion: Cmax of PSMA-Trillium-macropa peptide		Cycle 1, cycle 2 (From pre-dose up to Day 36 post-dose for each cycle)
Dose Escalation and Dose Expansion: AUC and AUC(0-tlast) of PSMA-Trillium-macropa peptide		Cycle 1, cycle 2 (From pre-dose up to Day 36 post-dose for each cycle)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): November 26, 2028
• Study Completion (Estimated): May 28, 2032

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mCRPC; PSMA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 22049; 2023-507486-26-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes