OnCo
drugsProductPhase 3

Giredestrant

Giredestrant is Roche's oral SERD: it failed to beat an aromatase inhibitor in first-line metastatic disease but succeeded after surgery and after CDK4/6 failure.

evERA (with everolimus after CDK4/6): PFS HR 0.56, HR 0.38 in ESR1-mutant; NDA accepted February 2026. lidERA (adjuvant): ~30% fewer invasive recurrences than standard endocrine therapy (SABCS 2025). persevERA (first-line with palbociclib): missed its primary endpoint (March 2026). Together these define where oral SERDs add value: resistance and adjuvant settings rather than upfront in unselected metastatic disease.

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Giredestrant
PubChem
Modality
Oral SERD
Mechanism
Oral SERD with full ER antagonism and degradation.
Brand / code
GDC-9545, RG6171
Dosing & schedule
Route
Oral
Schedule
30 mg once daily (trial dose)

Regulatory

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  1. 19 Feb 2026Filing / dealUS

    NDA accepted (evERA, ESR1-mutant) source

  2. 9 Mar 2026DesignationGlobal

    persevERA primary endpoint not met source

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Giredestrant
intervention: Giredestrant
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Landmark trials in OnCo

Latest papers

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Literature trend6 papers in the last 12 months0% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Giredestrant" OR ABSTRACT:"Giredestrant" OR TITLE:"GDC-9545" OR ABSTRACT:"GDC-9545" OR TITLE:"RG6171" OR ABSTRACT:"RG6171") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Giredestrant, not a curated reading list.

Connected

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