Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR439859
amcenestrant · 1 trial · 2 indications
Area under the plasma concentration versus time curve extrapolated to infinity
Terminal half-life associated with the terminal slope (λz)
Total body clearance
SAR439859 to radioactivity ratio for plasma AUC
Maximum plasm concentration observed
Time to reach Cmax
SAR439859 to radioactivity ratio for plasma AUC
M7 to SAR439859 ratio for plasma Cmax
M7 to SAR439859 ratio for plasma AUC
Absolute oral bioavailability, expressed as a percentage, estimated from AUCs obtained after oral and IV administration
| Arm | Type | Description |
|---|---|---|
| SAR439859 | EXPERIMENTAL | Single oral dose of SAR439859 at Day 1 in fasted condition followed by intravenous administration of \[14C\]-SAR439859 microtracer 3 hours later, and single oral dose of \[14C\]-SAR439859 at Day 7 in fasted condition |
| Name | Type | Description |
|---|---|---|
| amcenestrant | DRUG | Tablet Oral |
| [14C]-SAR439859 microtracer | DRUG | Solution for infusion Intravenous |
| [14C]-SAR439859 | DRUG | Powder for oral solution Oral |
Inclusion Criteria: Female participants (age between 40 and 75 years old) who are postmenopausal or had post-bilateral surgical oophorectomy not linked to a history of cancer. Participants who are overtly healthy. Body weight within 40.0 and 95.0 kg and body mass index (BMI) within the range 18.0 ...
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Amcenestrant is an investigational small molecule being developed by Sanofi for breast cancer. It has been studied in a Phase 1 clinical trial that included healthy post-menopausal women and involved breast cancer as a condition. It is not yet approved for any indication and remains in clinical development.
Amcenestrant targets ESR1, the gene encoding the estrogen receptor alpha. It is a degrader, meaning it works by promoting the breakdown of the estrogen receptor rather than simply blocking it. This mechanism is intended to interfere with estrogen receptor signaling in breast cancer.
Amcenestrant is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this investigational agent.
Amcenestrant is in Phase 1 clinical development. The only trial listed is a completed Phase 1 study, and no active trials are currently recorded. It is an investigational drug and has not been approved by the FDA or any regulatory agency.
Amcenestrant has been evaluated in a single Phase 1 trial, NCT04940026, titled a study to determine absorption, metabolism, and excretion of [14C]-SAR439859 and to assess absolute oral bioavailability of amcenestrant in healthy post-menopausal women. The trial was completed, enrolled 6 participants, and was conducted in the United Kingdom.
Yes, amcenestrant is also known as SAR439859. The two names refer to the same investigational drug developed by Sanofi. Clinical trial records and scientific literature may use either name interchangeably.