VEPPANU (vepdegestrant)
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Details
- Status
- Prescription
- First Approved
- 2026-05-01
- PDUFA Date
- 2026-06-05 (10d)
- Routes
- ORAL
- Dosage Forms
- TABLET
VEPPANU Approval History
What VEPPANU Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2026) NewLetter
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06125522 | C4891024 2023-507125-41-00 | Ph 1, Ph 2 | active not recruiting | TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) |
| NCT07231991 | C4891004 | Ph 1 | recruiting | A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function |
| NCT06206837 | C4891026 TACTIVE-K, 2023-508130-33-00 | Ph 1, Ph 2 | active not recruiting | A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer. |
| NCT06256510 | C4891039 2023-508518-40-00 | Ph 1 | completed | A Study to Learn If the Study Medicine Called Vepdegestrant Changes How the Body Processes the Other Study Medicine Called Midazolam |
| NCT05463952 results posted | C4891016 | Ph 1 | active not recruiting | A Study to Learn About the Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (BC) |
| NCT05538312 results posted | C4891009 2022-003282-38 | Ph 1 | completed | A Study to Understand the Effect of Itraconazole on the Levels of a Study Medicine Called ARV-471 in Healthy Adults |
| NCT06275841 | C4891035 | Ph 1 | completed | A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant |
| NCT06005688 PK | C4891011 2023-505881-27 | Ph 1 | completed | A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VEPPANU FDA Label Details
Indications & Usage
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is a heterobifunctional protein degrader indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1) -mutated advanced or metastatic breast cancer, as detect...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.