Updates are available Correction dated 2026-04-17

Article History

Received: 16 September 2025

Accepted: 19 February 2026

First Online: 18 March 2026

Change Date: 10 April 2026

Change Type: Update

Change Details: The original article has been corrected. The text 'does share' should have read 'does not share' under the 'Introduction' section.

Change Date: 17 April 2026

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40264-026-01675-5

Declarations

:

: All studies were sponsored by Bayer. The sponsor was involved in data analysis, validation, and manuscript development for the analysis presented in this publication and provided resources and administration support for the project.

: James H. Lewis is a member of the elinzanetant LSMB and paid consultant to Bayer; also a paid consultant to Astellas. James H. Lewis is an editorial board member of Drug Safety . James H. Lewis was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. Raúl J. Andrade is a member of the elinzanetant LSMB and a paid consultant to Bayer; also a paid consultant to Abbott, Boehringer Ingelheim, ENYO, GSK, Inventiva, Novartis, Novo-Nordisk, Roche, Ryvu Therapeutics, and Sanofi. Dominique Larrey is a member of the elinzanetant LSMB and a paid consultant to Bayer; also a paid consultant to Alentis, Akero, Alexion, Calliditas, Chiesi, Debiopharm, Freeline, Insilico, Inventiva, Merck, Pfizer, Ryvu, Sanofi, UCB, and Voiant. Yves Horsmans is a member of the elinzanetant DSMB and a paid consultant to Bayer; also a paid consultant to Debiopharm, Pharvaris, Chiesi, Jazz Pharmaceuticals, Novartis, and Johnson & Johnson. Richard A. Anderson is a member of the elinzanetant DSMB and a paid consultant to Bayer; also a paid consultant to Merck and Ferring. Lineke Zuurman is an employee of Bayer CC AG, Switzerland. Mila Trajanovic is an employee of Bayer US LLC, Whippany, NJ, USA. Esther Groettrup-Wolfers is an employee of Bayer AG, Germany.

: All the elinzanetant studies referenced were conducted in accordance with the Declaration of Helsinki and the Council for International Organizations of Medical Sciences International Ethical Guidelines. Institutional review board and ethics committee approval were obtained for all study sites.

: Not applicable.

: Not applicable.

: Availability of the data underlying this publication will 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 scientific and medical 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 USA and European Union (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 1 January 2014. Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. Data access will be granted to anonymized patient-level data, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.

: Not applicable.

: All authors contributed to the conceptualization and design of the analysis. Formal analysis was performed by Bayer and the Elinzanetant Liver Safety Monitoring Board (J.H.L., R.J.A., D.L.). Data curation was managed by L.Z., M.T., and E.G.W. The first draft was written by L.Z. and J.H.L. with medical writing support from Fourwave TM Medical Communications UK. All authors reviewed and edited drafts of the manuscript, and read and approved the final version of the manuscript for submission.