ER PROTAC degrader ยท degrader

vepdegestrant

0 active trials, targeting ER. 1 active approval for a biomarker on marked.bio.

Also known as ARV-471.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
vepdegestrant
FDA, 2026
advanced or metastatic, ESR1-mutated, after >=1 line of endocrine therapy FDA approval 01/05/2026; companion test Guardant360 CDx. Source
Veppanu
ESR1 mutation breast (ER+/HER2-) Approved 2026 Not approved

VERITAC-2 vs fulvestrant, 270 with ESR1 mutation
PFS 5.0 months vs 2.1 months, HR 0.57 (0.42-0.77)Response 19% vs 4%

Serious side effects 9%Stopped for side effects 2.9%Fatal 1.0%

Trial details and side effects
Patients
ESR1-mutated ER+/HER2- advanced breast cancer after CDK4/6 inhibitor (NCT05654623)
Most common side effects
musculoskeletal pain 30%, fatigue 29%, nausea 14%, decreased appetite 11%, constipation 10%, QT prolongation 10% (312 patients)
Notes
FDA approval summary (2026); OS immature. Warnings: QTc prolongation. Side effects: Veppanu US label, section 6 (VERITAC-2), via RxList.
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase

Trials

Status

0 of 0 trials shown