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Vepdegestrant (ARV-471/PF-07850327) (vepdegestrant-arv-471-pf-07850327)
Vepdegestrant (ARV-471/PF-07850327) (generic name: vepdegestrant-arv-471-pf-07850327) is a drug developed by Pfizer Inc.. It is currently in Phase 3 development.
Vepdegestrant (ARV-471/PF-07850327) is being studied in clinical trials for the treatment of breast cancer, including advanced or metastatic breast cancer. The exact mechanism of action of vepdegestrant is not specified in the provided information, but it is being investigated in combination with PF-07220060.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | vepdegestrant-arv-471-pf-07850327 |
|---|---|
| Sponsor | Pfizer Inc. |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- Hot flush
- Asthenia
- Constipation
- Nausea
- Arthralgia
- Fatigue
- Hypertension
- Insomnia
- Urinary tract infection
- Decreased appetite
- Headache
- Vertigo
Key clinical trials
- A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer (PHASE3)
- 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) (PHASE1, PHASE2)
- A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer. (PHASE1, PHASE2)
- Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer (PHASE3)
- 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 A) (PHASE1, PHASE2)
- A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function (PHASE1)
- 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) (PHASE1, PHASE2)
- A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vepdegestrant (ARV-471/PF-07850327) CI brief — competitive landscape report
- Vepdegestrant (ARV-471/PF-07850327) updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Vepdegestrant (ARV-471/PF-07850327)
What is Vepdegestrant (ARV-471/PF-07850327)?
Who makes Vepdegestrant (ARV-471/PF-07850327)?
What is the generic name of Vepdegestrant (ARV-471/PF-07850327)?
What development phase is Vepdegestrant (ARV-471/PF-07850327) in?
What are the side effects of Vepdegestrant (ARV-471/PF-07850327)?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing