NDAINTRAMUSCULARSOLUTION
Approved
May 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
FULVESTRANT (fulvestrant) by Fresenius Kabi is estrogen receptor antagonists [moa]. Approved for breast cancer. First approved in 2019.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fulvestrant is an estrogen receptor antagonist indicated for hormone receptor-positive breast cancer, administered via intramuscular injection. It works by binding to and degrading estrogen receptors, blocking estrogen-driven tumor growth. This selective estrogen receptor degrader (SERD) offers a distinct mechanism compared to aromatase inhibitors or tamoxifen.
Peak8.0 years to LOE
Product is at peak commercial performance with sustained market presence; expect stable but competitive team dynamics as competitors dominate market spending.
Mechanism of Action
Estrogen Receptor Antagonists
Pharmacologic Class:
Estrogen Receptor Antagonist
Indications (1)
Clinical Trials (20)
Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.
Started May 2026
51 enrolled
Metastatic (Stage IV) Melanoma
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Started Apr 2026
80 enrolled
Breast Cancer
Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment
Started Mar 2026
94 enrolled
Breast Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Started Feb 2026
80 enrolled
Breast Cancer
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
Started Nov 2025
312 enrolled
Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.