Cangrelor
Summary
Persistence. The potential for persistence of cangrelor cannot be excluded, due to lack of data.
Bioaccumulation. Cangrelor has low potential for bioaccumulation.
Toxicity. It cannot be excluded that cangrelor is toxic, due to lack of data.
Risk. Risk of environmental impact of cangrelor cannot be excluded, due to the lack of environmental toxicity data.
Cangrelor is rapidly metabolized to a nucleoside. The resulting metabolites are structurally related to the naturally occurring compounds adenine and adenosine.
This summary information for cangrelorc omes from fass.se and assessment report for Kengrexal (cangrelor).
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 Kengrexal (cangrelor), The Medicines Company UK, 22 January 2015, EMA/137542/2015.
Hazard
Persistence: No data.
Bioaccumulation: Cangrelor has log Dow values of -0.43 at pH 0, -0.91 at pH 1, and -2.22 at pH 2. The substance is not considered a potential PBT substance. Cangrelor is highly ionized at physiological pH and therefore highly hydrophilic, further supporting its low potential for bioaccumulation.
Toxicity: No data.
Risk
The predicted environmental concentration in surface water (PECsurface water) for cangrelor was 0.008 microg/L, which is below the threshold value of 0.01 microg/L. Therefore, no further environmental risk assessment was considered necessary.
Comment
Cangrelor has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of cangrelor (PECSurface water). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.
Fass environmental information
Fass environmental information for Kengrexal from Chiesi Pharma (retrieved on 2026-09-18).
Excretion (metabolism)
"Cangrelor is a substituted nucleotide that is rapidly inactivated by dephosphorylation to the nucleoside. Human metabolites produced and eliminated following administration of cangrelor are structurally related to the purine compounds, adenine and adenosine which are ubiquitous compounds in the environment."
Hazard
Persistence: No data.
Bioaccumulation: Cangrelor has log Dow values of -0.43 at pH 0, -0.91 at pH 1, and -2.22 at pH 2.
Toxicity: No data.
Risk
PEC is based on total sold amount API (active pharmaceutical ingredient) in Sweden year 2024.
PEC = 0.0000214816 microg/L.
"On the basis of the above result, since the PEC value is below 0.01 microg/L it may be assumed that the product is unlikely to represent a risk for the environment following its prescribed usage in patients."
Risk of environmental impact of cangrelor cannot be excluded, due to the lack of environmental toxicity data.
Author: Health and Medical Care Administration, Region Stockholm