Sonidegib
Summary
Persistence. Sonidegib is persistent and forms persistent metabolites.
Bioaccumulation. Sonidegib has high potential for bioaccumulation.
Toxicity. Sonidegib is considered to have very high chronic toxicity. The assessment is based on the available ecotoxicity data, adjusted according to the applied methodology due to missing data for one trophic level. Data are reported as greater than or equal to (≥) values; see the comment under the heading “Detailed Information”.
Risk. Risk of environmental impact from sonidegib cannot be excluded due to insufficient data. The submitted environmental risk assessment (ERA) was considered incomplete. The applicant committed to revising the environmental risk assessment and conducting a number of additional studies as part of the environmental risk assessment programme. No such data have been identified through searches of the EMA website (2026-08-20). In the Summary of Product Characteristics (SmPC) for Odomzo (sonidegib) (review date: November 2025), it is stated that environmental risk assessment studies have shown that sonidegib may pose a risk to surface waters.
This summary information on sonidegib is from the assessment report for Odomzo (sonidegib) 2015. Environmental information for sonidegib is missing on fass.se (2026-08-20).
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 Odomzo (sonidegib), Novartis Europharm Ltd, 25 June 2015, EMA/472165/2015.
Hazard
Persistence: Sonidegib is not readily biodegradable and exhibits very long half-lives (DT50 324–618 days at 12°C). The substance is considered very persistent (vP) and also forms persistent metabolites. An OECD 308 study further demonstrated long degradation half-lives in sediment (DT50 152–291 days at 20°C).
Bioaccumulation: Sonidegib has a high bioaccumulation potential (log Kow 5.7–5.8) and showed bioaccumulation in fish, with BCF values of 821–1022 L/kg.
Toxicity: There are data for 2 trophic levels, most sensitive fish (Danio rerio) OECD 2010 NOEC ≥ 10.5 microg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.
Risk
Risk of environmental impact from sonidegib cannot be excluded due to insufficient data.
The ERA submitted was considered incomplete. CHMP recommended that the environmental risk assessment (ERA) be updated with additional studies addressing sediment and terrestrial compartments, including soil degradation as well as effects on soil and sediment-dwelling organisms. Furthermore, a new algal study and a fish reproduction study were requested to evaluate long-term effects in the aquatic environment. The results were to be incorporated into a revised environmental risk assessment. No such data have been identified through searches of the EMA website (2026-08-20).
Author: Health and Medical Care Administration, Region Stockholm