Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Z-Endoxifen · 1 trial · 1 indication
Change from baseline
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | oral capsule |
| 1 mg (Z)-endoxifen | EXPERIMENTAL | oral capsule |
| 2 mg (Z)-endoxifen | EXPERIMENTAL | oral capsule |
| Name | Type | Description |
|---|---|---|
| Z-Endoxifen | DRUG | Z-Endoxifen |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Premenopausal women (defined as having at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if \<52 years) 2. Women of childbearing potential using a highly effective method of birth control\* throughout the stud...
Z-Endoxifen is an investigational small molecule being studied for breast density reduction in premenopausal women. It is being developed by Atossa Therapeutics, Inc. (NASDAQ: ATOS) and is currently in Phase 2 clinical development. The drug has received FDA orphan drug designation and rare pediatric disease designation.
Z-Endoxifen is an active metabolite of tamoxifen, a selective estrogen receptor modulator. It works by binding to estrogen receptors, thereby modulating estrogen signaling pathways. This mechanism is relevant to its potential effect on breast density, as estrogen influences breast tissue composition.
Z-Endoxifen is being developed by Atossa Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ATOS. The company is conducting clinical trials to evaluate the drug's safety and efficacy for reducing breast density in premenopausal women.
Z-Endoxifen is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed, and the drug is not yet available for commercial use.
Z-Endoxifen has been studied in a Phase 2 clinical trial with the identifier NCT05068388. This trial, titled 'Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density,' was a randomized, double-blind, placebo-controlled study conducted in Sweden. It enrolled 240 female participants aged 40 years and older.
Z-Endoxifen is the Z-isomer of endoxifen, which is the active metabolite of tamoxifen. While endoxifen exists as both E and Z isomers, Z-Endoxifen specifically refers to the Z-isomer form being developed by Atossa Therapeutics. This distinction is important for its pharmacological properties and clinical development.