Venetoclax

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 Venclyxto 2016

Assessment report for Venclyxto (venetoclax), AbbVie, 13 October 2016, EMA/725631/2016.

Hazard

Persistence: PBT-assessment: Venetoclax was considered not readily biodegradable. Temperature-corrected DT₅₀ values at 12°C were reported as 17–23 days in water, 121–367 days in sediment, and 100–185 days for the entire water-sediment system. Soil DT₅₀ values ranged from 278 to 981 days. Based on these data, the substance was considered very persistent (vP). Phase II: In an OECD 308 study (aerobic and anaerobic transformation in aquatic sediment systems), DT₅₀ values at 20°C were reported as 7.8–11 days in water, 53–173 days in sediment, and 47–87 days for the entire water-sediment system. In addition, a substantial partitioning to sediment was observed, with 85–98% of the substance being associated with the sediment phase. Comment: According to CHMP guidance on environmental risk assessment, persistence studies should reflect environmental conditions in Europe and should therefore preferably be conducted or reported at 12°C. The DT₅₀ values reported under the "PBT assessment" were corrected to this temperature.

Bioaccumulation: Venetoclax has high log K_ow values (4.77–5.91 depending on pH). At the same time, a very low BMF value (0.0048 kg/kg) was reported, indicating a low potential for biomagnification in the food chain.

Chronic toxicity: Data are available for one trophic level, crustaceans (Daphnia sp.), with an EC₁₀ of 3.3 microg/L.

Risk

The CHMP recommends correction of the PEC calculation.

Assessment report Venclyxto 2020

Assessment report for Venclyxto, AbbVie, type II variations for extension of indication, 30 January 2020, EMA/166265/2020.

An updated environmental risk assessment was submitted following a change in indication. In Phase I, the predicted environmental concentration (PEC) in surface water was calculated to be 0.096 microg/L, exceeding the action limit of 0.01 microg/L and therefore leading to a Phase II environmental risk assessment. In Phase II, persistence, bioaccumulation and toxicity (PBT) were evaluated. All PEC/PNEC ratios for water, groundwater, microorganisms, sediment and soil were below 1, indicating that no further testing was considered necessary. The new indication was not expected to result in a significant increase in environmental exposure, and venetoclax was therefore not expected to pose a risk to the environment.

Assessment report Venclyxto 2026

Two assessment reports for Venclyxto (AbbVie), related to Type II variations, were identified from April 2026 and contain largely identical information. The summary below is based on the report dated 23 April 2026, (EMADOC-1700519818-3010802).

No new environmental risk assessment (ERA) was submitted. Previous ERA data for venetoclax were used. The PEC for surface water exceeded the action limit and led to a Phase II assessment. All PEC/PNEC ratios were < 1. However, the CHMP considered the ERA not fully aligned with current guidance and recommended a re-evaluation before reaching a final conclusion on environmental risk. No such supplementary data were identified during a search of the EMA website on 21 August 2026.

Fass environmental information

Fass environmental information for Venclyxto from AbbVie (retrieved on 2026-08-20).

Hazard

Persistence: In an OECD 308 study of aerobic transformation in aquatic sediment systems, the DT₅₀ for the total system was 47–87 days. Venetoclax was therefore considered to degrade slowly in the environment.

Bioaccumulation: Venetoclax has high log K_ow values (4.77–5.91), but BMF values were very low (< 0.01) and calculated BCF values were < 500. Venetoclax was therefore considered to have a low potential for bioaccumulation.

Chronic toxicity: There are data for 3 trophic levels, most sensitive crustacean species (Daphnia magna) NOEC of 7.3 microg/L.

Risk

PEC/PNEC is based on total sold amount API (active pharmaceutical ingredient) in Sweden year 2021.

PEC = 0.0024 microg/L.

PNEC = Lowest NOEC, 7.3 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.73 microg/L.

PEC/PNEC = 0.0033 which gives the risk insignificant.