Drugs / vepdegestrant
vepdegestrant
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VEPPANU | — | 2026-05-01 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT07231991 | Nov 2025 → Dec 2026 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT06911788 | Apr → May 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06645938 | Oct 2024 → Feb 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06347861 | Apr → Jul 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06275841 | Feb → May 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06256510 | Feb → Apr 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06005688 | Aug → Oct 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05930925 | Jun → Jul 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05538312 | Feb → Apr 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05732428 | Feb 2023 → Mar 2024 | breast cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05673889 | Jan → Mar 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05652660 | Dec 2022 → Feb 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05501769 | Sep 2022 → Jul 2024 | breast cancer | Arvinas Estrogen Receptor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05463952 | Aug 2022 → May 2023 overdue | breast neoplasm | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT06206837 | Feb 2024 → Sep 2025 overdue | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06125522 | Jan 2024 → Dec 2026 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05573555 | Mar 2023 → Dec 2026 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05548127 | Feb 2023 → Sep 2026 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04072952 | Aug 2019 → Sep 2024 | breast cancer | Arvinas Estrogen Receptor, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05549505 | Feb 2023 → Jul 2024 | breast cancer | Arvinas Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04606446 | Nov 2020 → Jul 2029 expected | breast cancer, castration-resistant prostate carcinoma, non-small cell lung carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05909397 | Aug 2023 → Dec 2026 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05654623 | Mar 2023 → Jan 2025 overdue | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-31 | Pfizer | Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer pfizer.com ↗ |
| 2024-12-10 | Pfizer | Arvinas and Pfizer Announce Initial Phase 1b Data from the TACTIVE-U Sub-Study of Vepdegestrant in Combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium pfizer.com ↗ |
| 2021-12-10 | Pfizer | Arvinas and Pfizer Announce PROTAC® Protein Degrader ARV-471 Continues to Demonstrate Encouraging Clinical Benefit Rate in Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer pfizer.com ↗ |
| 2021-11-19 | Pfizer | Arvinas And Pfizer Announce Updated Phase 1 Dose Escalation Data For ARV-471 To Be Presented In Spotlight Poster Session At 2021 San Antonio Breast Cancer Symposium pfizer.com ↗ |
| 2021-07-22 | Pfizer | Arvinas And Pfizer Announce Global Collaboration To Develop And Commercialize Protac® Protein Degrader Arv-471 pfizer.com ↗ |
| 2021-07-22 | Pfizer | Arvinas and Pfizer Announce Global Collaboration to Develop and Commercialize PROTAC® Protein Degrader ARV-471 pfizer.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vepdegestrant | “Vepdegestrant (ARV-471) is an oral PROTAC ER degrader that binds an E3 ubiquitin ligase and ER to directly trigger ubiquitination of ER and its subsequent proteasomal degradation.” PMID 39072356 ↗ Jul 202415“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 B)” NCT05573555 ↗ “Vepdegestrant (ARV-471, PF-07850327)” NCT05732428 ↗ |
| Known as | ARV-471 | “Vepdegestrant (ARV-471) is an oral PROTAC ER degrader that binds an E3 ubiquitin ligase and ER to directly trigger ubiquitination of ER and its subsequent proteasomal degradation.” PMID 39072356 ↗ Jul 202413“Vepdegestrant (ARV-471, PF-07850327)” NCT05732428 ↗ “vepdegestrant (ARV-471, PF-07850327)” NCT06275841 ↗ “Vepdegestrant (ARV-471/PF-07850327)” NCT05909397 ↗ “PF-07850327, ARV-471, vepdegestrant” NCT04606446 ↗ |
| Known as | ARV-471 (PROTAC) | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095210 ↗ |
| Known as | PF-07850327 | “VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA” NCT05573555 ↗4“Vepdegestrant (ARV-471, PF-07850327)” NCT05732428 ↗ “vepdegestrant (ARV-471, PF-07850327)” NCT06275841 ↗ “Vepdegestrant (ARV-471/PF-07850327)” NCT05909397 ↗ “PF-07850327, ARV-471, vepdegestrant” NCT04606446 ↗ |
| Action | Inhibit | “directly trigger ubiquitination of ER and its subsequent proteasomal degradation” PMID 39072356 ↗ Jul 2024 |
| Modality | Other / unclassified | “Vepdegestrant (ARV-471) is an oral PROTAC ER degrader” PMID 39072356 ↗ Jul 2024 |
| Route | Oral | “ARV-471: 200 mg QD, p.o” NCT01042379 ↗ |