Vibegron
Summary
Persistence. It cannot be excluded that vibegron is persistent, due to lack of data.
Bioaccumulation. Vibegron has low potential for bioaccumulation.
Toxicity. It cannot be excluded that vibegron is toxic, due to lack of data.
Risk. Both ecotoxicological effect data and environmental measurements are limited for incontinence pharmaceuticals. However, excretion data, available ecotoxicological effect data, and risk assessment using the fish plasma model for both parent compounds and active metabolites consistently indicate a negligible environmental risk associated with the use of the three anticholinergic substances solifenacin, tolterodine, and fesoterodine from a Swedish perspective. For mirabegron, which is considered persistent in the environment, the risk is somewhat higher but still low. Therefore, no substitutions are recommended from an environmental risk perspective. There were no sales of vibegron in Sweden in 2024. The molecule, however, has properties, particularly its lipophilicity, which together with its likely persistence indicate a potentially high environmental hazard. If future sales of vibegron become substantial, a potential environmental risk may therefore arise. In preparation for such a scenario, it would be highly valuable to generate data on its persistence, occurrence in wastewater, surface waters and biota, as well as its ecotoxicity in fish, to improve the risk assessment.
This summary information comes from assessment report. The risk assessment is taken from the Goodpoint 2026 review.
Detailed information
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
Assessment report
Assessment report for Obgemsa (vibegron), Pierre Fabre Medicament, 25 April 2024, EMA/226759/2024.
Hazard
Persistence: No data.
Bioaccumulation: Log Kow similar to OECD TG107 (non GLP) = 0.19.
Toxicity: No data.
Risk
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PECsurfacewater = 3.78 microg/L > 0.01 threshold.
The refined PECsurfacewater of 3.78 µg/L exceeds the action limit of 0.01 µg/L, thereby triggering a phase IIA assessment. No phase II data for vibegron were submitted. The Applicant has committed to submitting a phase II ERA in accordance with the “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 2, 01 June 2006)” by Q4 2025. Vibegron is not considered a PBT substance. The available data do not allow a conclusion on the potential environmental risk. No such requested data were found in a search of the EMA website on 2026‑01‑16.
Environmental assessment by Goodpoint 2026
Both ecotoxicological effect data and environmental measurements are limited for incontinence pharmaceuticals. However, excretion data, available ecotoxicological effect data, and risk assessment using the fish plasma model for both parent compounds and active metabolites consistently indicate a negligible environmental risk associated with the use of the three anticholinergic substances solifenacin, tolterodine, and fesoterodine from a Swedish perspective. For mirabegron, which is considered persistent in the environment, the risk is somewhat higher but still low. Therefore, no substitutions are recommended from an environmental risk perspective. There were no sales of vibegron in Sweden in 2024. The molecule, however, has properties, particularly its lipophilicity, which together with its likely persistence indicate a potentially high environmental hazard. If future sales of vibegron become substantial, a potential environmental risk may therefore arise. In preparation for such a scenario, it would be highly valuable to generate data on its persistence, occurrence in wastewater, surface waters and biota, as well as its ecotoxicity in fish, to improve the risk assessment.
Author: Health and Medical Care Administration, Region Stockholm