Pipeline Overview

Investigational drug product candidate abaloparatide-SC

In 2018, we initiated a Phase 3 study (ATOM), assessing the efficacy and safety of abaloparatide injection for the treatment of osteoporosis in men. The randomized, double-blind, placebo-controlled trial enrolled a total of 228 men with osteoporosis. In October 2021, Radius announced positive topline results from the ATOM trial. Following FDA review, in 2022 Radius announced the approval of abaloparatide injection for the treatment of osteoporosis in men.

Clinical Trial

Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

Investigational drug product candidate abaloparatide-TD

In August 2019, we initiated our Phase 3 wearABLe study of abaloparatide transdermal system (“abaloparatide-TD”), a single, pivotal, randomized, open label, active-controlled, bone mineral density (“BMD”) non-inferiority bridging study with a planned enrollment of approximately 470 patients with postmenopausal osteoporosis at high risk of fracture. The topline results were reported in December 2021.

Clinical Trial

A Randomized, Non-inferiority, Phase 3, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women With Osteoporosis (the wearABLe Study)

Investigational drug product candidate elacestrant

Elacestrant is a selective estrogen receptor degrader (SERD) out-licensed to Menarini Group which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

In 2018 we initiated and opened for enrollment a Phase 3 study (EMERALD) evaluating elacestrant as second- or third-line monotherapy in postmenopausal women with advanced/metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients. The study achieved its enrollment target of 466 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. In October 2021, the Radius and Menarini group jointly announced positive topline results from the EMERALD trial.

Clinical Trial

Elacestrant Monotherapy for the Treatment of ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)