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Drug intelligence / Profile preview
TOL2506 (leuprolide acetate)
- Development stage
- Approved
- Lead developer
- Tolmar
- Modality
- Small Molecules
- Administration
- Subcutaneous
01
Overview
TOL2506 is a 3-month, extended-release formulation of leuprolide acetate (LA), developed specifically to suppress ovarian function in premenopausal women with hormone receptor-positive (HR+), HER2-negative breast cancer. It utilizes an in situ polymeric extended release technology to deliver higher drug exposure compared to currently available 3-month LA formulations used for advanced prostate cancer. The primary mechanism is as a gonadotropin-releasing hormone (GnRH) agonist, which suppresses the pituitary-gonadal axis and reduces estrogen production by downregulating luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This ovarian suppression is intended as part of endocrine therapy regimens for breast cancer. TOL2506 is administered subcutaneously every three months and is being evaluated in phase 3 clinical trials under the brand name OVELIA[1][2][3][4][5].
- Brand names
- OVELIA
- Other names
- leuprolide acetate for injectable suspensionTOL2506ATOL-2506ATOL 2506A
02
Targets
GnRHR (Gonadotropin-releasing hormone receptor)
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