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Description

Hydroxytamoxifen (Afimoxifene) is an active metabolite of tamoxifen exerting estrogen receptor modulatory function. In addition, hydroxytamoxifen binds to regulates transcriptional activity of the estrogen-related receptor gamma. ASCEND Therapeutics, Inc. was developing TamoGel (4-hydroxytamoxifen gel) for a variety of estrogen-dependent conditions, including breast cancer, cyclic breast pain and gynecomastia.

CNS Activity

Originator

Approval Year

Targets

Primary TargetPharmacologyConditionPotency

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Unknown
Primary
Unknown

Cmax

ValueDoseCo-administeredAnalytePopulation
3.6 ng/mL
1 mg/kg single, oral
HYDROXYTAMOXIFEN plasma
Mus musculus

AUC

ValueDoseCo-administeredAnalytePopulation
61.5 ng × h/mL
1 mg/kg single, oral
HYDROXYTAMOXIFEN plasma
Mus musculus

T1/2

ValueDoseCo-administeredAnalytePopulation
31.7 h
1 mg/kg single, oral
HYDROXYTAMOXIFEN plasma
Mus musculus

Doses

Drug as perpetrator​

Drug as victim

PubMed

Sample Use Guides

In Vivo Use Guide
A phase II trial of Afimoxifene (4-hydroxytamoxifen gel) for cyclical mastalgia in premenopausal women. Premenopausal women aged at least 18 years experiencing moderate to severe symptoms were randomized to receive placebo, 2 mg, or 4 mg of Afimoxifene daily delivered as a transdermal hydroalcoholic gel for 4 menstrual cycles.
Route of Administration: Transdermal
In Vitro Use Guide
Viability of T47D, MCF-7 and BT-474 cell lines to 4-hydroxytamoxifen was dependent of its dose, and IC50 values after 96 h of treatment were 4.2, 3.2 and 5.7 μM, respectively
Substance Class Mixture
Record UNII
17197F0KYM
Record Status Validated (UNII)
Record Version
All of the following components must be present:
Definition References
(3)