Product Description
Fulvestrant is a pure antiestrogen that emerged from a systematic medicinal chemistry strategy of modification of long-chain alkyl substitutes in the 7a-position of estradiol. Fulvestrant has no uterotrophic effects on the immature or ovariectomized rat and blocks the agonistic effects of estradiol and tamoxifen in a dose-dependent manner. In in vivo and in vitro breast cancer models, fulvestrant has anticancer activity at least as good as tamoxifen and is superior to tamoxifen in some models. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/15865849/)
Mechanisms of Action: ER Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intramuscular
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Back Pain | Headache | Low Back Pain | Pain Unspecified | Arthralgia | Bone Cancer | Breast Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified | Dyspnea | Anorexia | Asthenia | Constipation | Back Pain | Headache | Low Back Pain | Pain Unspecified | Arthralgia | Musculoskeletal Pain | Bone Cancer | Breast Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified | Contraception | Dyspnea | Anorexia | Asthenia | Constipation
Known Adverse Events: Back Pain | Headache | Low Back Pain | Pain Unspecified | Arthralgia | Bone Cancer | Breast Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified | Dyspnea | Anorexia | Asthenia | Constipation | Musculoskeletal Pain
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 85
Highest Development Phases
Phase 3: Breast Cancer|Breast Cyst
Phase 2: Adenocarcinoma|Adenosarcoma|Breast Diseases|Ductal Breast Carcinoma|Ductal Carcinoma|Endometrial Cancer|Endometrial Stromal Tumors|Leiomyosarcoma|Ovarian Cancer|Sarcoma, Endometrial Stromal|Serous Cystadenocarcinoma|Sex Cord-Gonadal Stromal Tumors|Tic Disorders|Uterine Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| WO41554 | P3 |
Unknown Status |
Breast Cancer |
2030-09-30 |
|
| WO43919 | P3 |
Unknown Status |
Breast Cancer |
2029-03-30 |
|
| INAVO121 | P3 |
Recruiting |
Breast Cancer |
2029-03-30 |
|
| jRCT2051230196 | P3 |
Recruiting |
Breast Cancer |
2028-11-13 |