NDAINTRAMUSCULARSOLUTION
Approved
Apr 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
FASLODEX (fulvestrant) by AstraZeneca is estrogen receptor antagonists [moa]. First approved in 2002.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FASLODEX (fulvestrant) is a selective estrogen receptor degrader (SERD) administered intramuscularly for hormone receptor-positive (HR+) breast cancer. It works by antagonizing estrogen receptors and promoting their degradation, blocking estrogen signaling in cancer cells. The drug is indicated for HR+ metastatic breast cancer, typically in post-menopausal women or as adjunctive therapy with other agents.
$0.293MPart D
LOE ApproachingProduct is in late-stage lifecycle with approaching loss of exclusivity, signaling defensive positioning and reduced commercial team expansion.
Mechanism of Action
Estrogen Receptor Antagonists
Pharmacologic Class:
Estrogen Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
Started Oct 2026
25 enrolled
Advanced Breast CancerHormone Receptor Positive / HER2-negative Breast CancerHER2 Mutation
A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.
Started Jun 2026
160 enrolled
Breast Cancer
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
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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.