Drugs / vepdegestrant
vepdegestrant
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed progesterone-receptor positive breast cancer 2 milestones | |||||
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2025-11-05 | “Announced the U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for vepdegestrant” arvinas.com ↗ “The U.S. Food and Drug Administration (FDA) is reviewing the filed New Drug Application (NDA) for vepdegestrant.” arvinas.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2025-08-06 | “On August 8, 2025, the FDA accepted the New Drug Application (NDA) for vepdegestrant (ARV-471) to treat ER+/HER2-, ESR1 -mutated advanced breast cancer” rigel.com ↗ “Submitted a New Drug Application to the U.S. Food and Drug Administration for vepdegestrant.” arvinas.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | VEPPANU | — | 2026-05-01 | fda.gov ↗ |
Trials 24
| 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 → Sep 2026 | breast cancer | Pfizer | Completed | 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 → Mar 2027 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04072952 | Sep 2019 → Sep 2024 | breast cancer | Arvinas Estrogen Receptor, Inc. | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT06590857 Background | Jul 2024 → Oct 2028 expected | hormone receptor-positive breast cancer, metastatic carcinoma in the bone | RayzeBio, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-05-12 | Arvinas Inc. | Regulatory Arvinas Reports First Quarter 2026 Financial Results and Provides Corporate Update arvinas.com ↗ |
| 2026-05-01 | Arvinas Inc. | Regulatory Arvinas Announces FDA Approval of VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer arvinas.com ↗
FDA approval was granted based on data from VERITAC-2 (NCT05654623), a global, randomized, open-label, pivotal Phase 3 clinical trial evaluating vepdegestrant versus fulvestrant. |
| 2025-10-20 | Arvinas Inc. | Results Patient-Reported Outcomes from VERITAC-2 Clinical Trial Support Clinical Benefit of Vepdegestrant in Patients with ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer Previously Treated with Endocrine-Based Therapy arvinas.com ↗
In the VERITAC-2 clinical trial, patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to those who received fulvestrant. |
| 2025-08-08 | Arvinas Inc. | Regulatory Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer arvinas.com ↗ |
| 2025-06-06 | Arvinas Inc. | Regulatory Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer arvinas.com ↗ |
| 2025-05-31 | Pfizer | Results Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer pfizer.com ↗
Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival when compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation |
| 2025-05-31 | Arvinas Inc. | Results Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer arvinas.com ↗
Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival when compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation |
| 2025-03-11 | Pfizer | Results Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial pfizer.com ↗
The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant. |
| 2025-03-11 | Arvinas Inc. | Results Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial arvinas.com ↗
The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant. |
| 2024-12-10 | Pfizer | Results 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 ↗
An encouraging clinical benefit rate of 62.5% was observed among patients with both mutant ESR1 and wild-type ESR1 disease who had all been previously treated with a CDK4/6 inhibitor. |
| 2024-12-10 | Arvinas Inc. | Results 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 arvinas.com ↗
Preliminary results from 16 patients in the Phase 1b sub-study demonstrated a tolerable safety profile for the combination of abemaciclib 150 mg twice daily (BID) with the recommended Phase 3 monotherapy dose of vepdegestrant (200mg once daily; QD). |
| 2024-12-05 | Pfizer | Results Pfizer Showcases Scientific Leadership in Breast Cancer and Blood Disorders Across More than 100 Presentations at ASH and SABCS pfizer.com ↗
These data reinforce the potential of vepdegestrant as a new backbone endocrine therapy, and Pfizer and Arvinas anticipate topline Phase 3 data evaluating vepdegestrant as a monotherapy in the first quarter of 2025. |
| 2024-05-16 | Arvinas Inc. | Results Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) arvinas.com ↗
After six months of additional follow-up, clinical benefit rate (63%), overall response rate (41.9%), median progression-free survival (11.2 months), and safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023 |
| 2024-02-06 | Arvinas Inc. | Regulatory Arvinas and Pfizer’s Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast Cancer arvinas.com ↗ |
| 2023-12-05 | Arvinas Inc. | Results Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) and Plans to Expand Vepdegestrant Development Program arvinas.com ↗
Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC ® ) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE ® ). |
| 2023-07-31 | Arvinas Inc. | Regulatory Arvinas and Pfizer Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Vepdegestrant, an Investigational PROTAC® ER degrader being developed in ER+/HER2- Breast Cancer arvinas.com ↗ |
| 2023-05-05 | Arvinas Inc. | Results Arvinas Reports First Quarter 2023 Financial Results and Provides Corporate Update arvinas.com ↗
Preliminary data from the Phase 1b combination trial of vepdegestrant + palbociclib suggests potential clinical benefit in a heavily pretreated patient population |
| 2022-11-22 | Arvinas Inc. | Results Arvinas Announces ARV-471 Achieves a Clinical Benefit Rate of 38% in Evaluable Patients and Continues to Show a Favorable Tolerability Profile in its Phase 2 Expansion Trial (VERITAC) arvinas.com ↗
Arvinas, Inc. (Nasdaq: ARVN) today announced initial results from the Phase 2 cohort expansion portion (VERITAC) of a phase 1/2 study with ARV-471, a novel PROTAC® estrogen receptor (ER) protein degrader. |
| 2021-12-10 | Pfizer | Results 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 ↗
ARV-471 demonstrated antitumor activity in CDK4/6 inhibitor-pretreated patients with a clinical benefit rate (CBR) of 40% in 47 evaluable patients. |
| 2021-12-10 | Arvinas Inc. | Results 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 arvinas.com ↗
ARV-471 demonstrated antitumor activity in CDK4/6 inhibitor-pretreated patients with a clinical benefit rate (CBR) of 40% in 47 evaluable patients. |
| 2020-12-14 | Arvinas Inc. | Results Arvinas Releases Interim Clinical Data Further Demonstrating the Powerful Potential of PROTAC® Protein Degraders ARV-471 and ARV-110 arvinas.com ↗
The efficacy signals include one Response Evaluation Criteria in Solid Tumors (RECIST) confirmed partial response (PR), two additional patients with unconfirmed PRs, and a clinical benefit rate (CBR) of 42%. |
| 2019-10-23 | Arvinas Inc. | Results Arvinas Presents a Platform Update, Including Initial Data from the First Two Clinical Trials of PROTAC® Targeted Protein Degraders arvinas.com ↗ |
| 2019-06-25 | Arvinas Inc. | Regulatory Arvinas Receives Authorization to Proceed for ARV-471, a PROTAC® Protein Degrader to Treat Patients with Locally Advanced or Metastatic ER+ / HER2- Breast Cancer arvinas.com ↗
Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that the U.S. Food and Drug Administration ( FDA ) has cleared the company’s Investigational New Drug application (IND) for ARV-471, an oral estrogen receptor (ER) PROTAC ® protein degrader, designed to selectively target ER for the treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer. |
| 2018-12-07 | Arvinas Inc. | Results Arvinas Presents Preclinical Data on Protein Degrader, ARV-471, at the 2018 San Antonio Breast Cancer Symposium (SABCS) arvinas.com ↗
Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today presented positive preclinical data on the company's lead clinical candidate, ARV-471, for advanced or metastatic ER-positive/HER2-negative breast cancer at the 2018 San Antonio Breast Cancer Symposium (SABCS), taking place December 4-8 in San Antonio, Texas (Poster P5-04-18; Session 5: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance). |
All press releases naming this drug 47 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 26 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 202417“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 ↗ “Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant” NCT06590857 ↗ “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 202412“vepdegestrant (ARV-471, PF-07850327)” NCT06275841 ↗ “Vepdegestrant (ARV-471, PF-07850327)” NCT05732428 ↗ “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 | “an oral proteolysis targeting chimera” NCT05548127 ↗ |
| Route | Oral | “ARV-471: 200 mg QD, p.o” NCT01042379 ↗ |